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Pharmaceutical reference substances and impurities from LGC GmbH
For further information, or if you require substances or materials not currently listed please contact one of our local sales offices.
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HungaryTel: +36 (06) 26 314 891Email: [email protected] served:Croatia, Hungary, Slovenia
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www.lgcstandards.com
Contents
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 1
ContentsIntroduction
Background 2
About LGC 2
Certification 2
Narcotics 3
Delivery time 3
Certificate of Accreditation according ISO Guide 34:2009 4
Certificate of Accreditation according DIN EN ISO/IEC 17025:2005 5
Certificate of analysis 6
Pharmaceutical impurities List of products 10
Pharmaceutical impurities
2 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Pharmaceutical impurities Background
The pharmacopeial monographs regulate the legal definition but also the analysis and the limits of impurities in a given substance. Impurities in a pharmaceutical substance can change the effects and side effects of a drug significantly. It is therefore important to have an accurate detection of impurities. The increasing importance of impurity reference materials is also becoming apparent in the registration of drugs, where an exact identification and quantification of susceptible impurities is required for an assured documentation. A wide range of known impurities is listed in individual pharmacopeial monographs. However, impurities that are still protected by a patent, as well as those that are only known to the manufacturer, are not listed. Guidelines and limits for impurities have been laid out in compendial monographs, in specifications from the manufacturer internally or in the International Conference on Harmonisation (ICH) Guidelines which have been agreed by Europe, Japan and the United States. The ICH conducted three guidelines on impurity issues:
ICH Q3A (R1): Impurities in New Drug Substances ICH Q3B (R2): Impurities in New Drug Products ICH Q3C (R3): Impurity Guidelines for Residual Solvents.
The full wording of the ICH guidelines is available at the official website of the ICH: www.ich.org.
About LGC The pharmaceutical impurities listed in this section are produced by LGC, whose Research & Technology Division acts as the designated UK National Measurement Institute for Chemical and Biochemical Measurements. LGC is an independent, science-based service company providing chemical, biochemical and DNA based analytical and diagnostic services, and reference standards. LGC is Europe's largest, independent analytical laboratory.Its services include analytical testing, research, consultancy, validation, training and knowledge transfer. LGC Standards, a division of LGC, provides the most comprehensive source of certified reference materials and standards, pharmaceutical reference substances and impurities, biomaterials, cell lines and high purity solvents to the scientific community worldwide. LGC Standards has successfully established a global reputation for the production of impurities and working standards, and as a single source for the supply of pharmacopeia reference materials. Our menu of custom services, including custom synthesis of impurities and metabolites, characterisation, certification, packaging and distribution, adds value to the scientific support we provide to our pharmaceutical customers. For more information about these services, please contact your local LGC Standards office.
Certification Each product is accompanied by a detailed certificate of analysis, which gives information on the identity and purity, together with the various analytical methods and their conditions. A sample of such a certificate is printed on the following pages. In the past, we received some inquiries from a few customers wondering why there is no declaration on the certificates of analysis (CofA) for LGC products stating that the substances are fulfilling the specifications for reagents, as described for example in chapter 4 of the European Pharmacopeia. The LGC impurity standards are thoroughly tested chemical reference substances and are used for reliable identification and quantification of impurities of pharmaceutical ingredients and products. The abbreviations EP, Pharmeuropa, BP and USP in the article description are indicating that the particular substance is mentioned as an impurity in that particular compendial publication. They do not indicate that certain specification of reagents or drug substances mentioned in the publications are fulfilled. The standards – where they are actually listed as reagents or drug substances – may fulfill this specification, but this is not the intention and is not certified on the CofA. LGC GmbH in Luckenwalde has reached the peak of the accreditation for the production of pharmaceutical reference substances. The accreditation according to ISO guide 34, which has been developed for producers of certified reference materials, completes the way from the ISO 9001 ff quality management and the confirmation of the accretitation body DQS that the company´s system respects the rules of "Good Manufacturing Practice (GMP)" via the EN ISO/IEC 17025 for their analytical laboratory. The company takes over Europe´s leading role for pharmaceutical reference substances of this high quality level and is the only one in Germany.
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 3
Narcotics Some of the substances described in this section are subject to narcotics legislation. These are marked as [Controlled Substance]. Please contact your local LGC Standards office for information on the legal requirements in order to purchase these products.
Delivery time The majority of products mentioned in this section are available from stock; others may have a delivery time of approximately four weeks. For substances marked with "on request", longer delivery times may apply. For custom synthesis, the time is estimated from previous experience. Customers will be notified if unforeseen complications arise during the synthesis. In the unlikely event that a synthesis does not reach the expected result, LGC Standards reserves the right to cancel the order.
Pharmaceutical impurities
10 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Products Code Product Code Unit
4-Aminobenzoic Acid MM 0094.00 Imp. B (EP): Benzocaine
H2N
O
O (A) 500 mg
MM 0093.17 Imp. C (EP) as Hydrochloride: Aniline Hydrochloride H2N
x HCl(B) 100 mg
Acebutolol Hydrochloride MM 0435.00 Acebutolol Hydrochloride O
OOH H
N
NH
O
x HCl
(A) 500 mg
MM 0435.01 Imp. A (EP): N-[3-Acetyl-4-[(2RS)-oxiran-2-ylmethoxy]phenyl]butanamide
O
OO
NH
O
(A) 50 mg
MM 0435.02 Imp. B (EP) as Hydrochloride:N-[3-Acetyl-4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino]-propoxy]phenyl]acetamide Hydrochloride (Diacetolol Hydrochloride)
O
OOH
HN
NH
O x HCl
(A) 100 mg
MM 0435.03 Imp. C (EP): N-(3-Acetyl-4-hydroxyphenyl)butanamide O
OH
NH
O
(A) 100 mg
MM 0435.04 Imp. D (EP) as Hydrochloride: 1-[5-Amino-2- [(2RS)-2-hydroxy-3-[(1-methylethyl)amino]- propoxy]phenyl]ethanone Dihydrochloride
O
OOH
HN
H2N
x 2 HCl
(A) 50 mg
MM 0435.05 Imp. E (EP) as Hydrochloride: N-[4-[(2RS)-2- Hydroxy-3-[(1-methylethyl)amino]propoxy]- phenyl]butanamide Hydrochloride
O
OHHN
NH
O x HCl
(A) 50 mg
MM 0435.06 Imp. F (EP): N-[3-Acetyl-4-[(2RS)-2,3-dihydroxypropoxy]phenyl]butanamide
O
O
OH
OH
NH
O
(A) 50 mg
MM 0435.07 Imp. G (EP): N,N'-[[(1-Methylethyl)imino]-bis[(2-hydroxypropane-1,3-diyl)oxy(3-acetyl-1,4-phenylene)]]dibutanamide (Acebutolol Biamine)
O
O
OH
N
HN
O
OHO
O
NH
O
(A) 50 mg
MM 0435.08 Imp. H (EP): N,N'-[(2-Hydroxypropane-1,3-diyl)bis[oxy(3-acetyl-1,4-phenylene)]]di-butanamide
O
O
OH
O
HN
O
O
NH
O
(A) 50 mg
MM 0435.09 Imp. I (EP): N-[3-Acetyl-4-[(2RS)-3-(ethylamino)-2-hydroxypropoxy]-phenyl]butanamide
O
O
OHHN
NH
O
(A) 50 mg
MM 0435.10 Imp. J (EP) as Hydrochloride: N-[3-Acetyl-4- [(2RS)-2-hydroxy-3-[(1-methylethyl)amino]- propoxy]phenyl]propanamide Hydrochloride
O
OHN
NH
O
OH
x HCl
(A) 50 mg
MM 0435.11 Imp. K (EP) as Hydrochloride: N-[3-Butanoyl-4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino]-propoxy]phenyl]butanamide Hydrochloride
O
O
OHHN
NH
O x HCl
(A) 50 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 11
Code Product Code Unit
Aceclofenac MM 0181.00 Aceclofenac
NHClCl
O
OOH
O (A) 250 mg
MM 0006.20 Imp. A (EP): [2-[(2,6-Dichlorophenyl)amino]phenyl]acetic Acid (Diclofenac)
NH
ClCl
OH
O
(A) 100 mg
MM 0006.10 Imp. B (EP): Methyl [2-[(2,6-Dichlorophenyl)amino]phenyl]acetate (Methyl Ester of Diclofenac) NH
ClCl
O
O
(A) 100 mg
MM 0006.11 Imp. C (EP): Ethyl 2-{2-[(2,6-dichlorophenyl)amino]phenyl}acetate (Ethyl Ester of Diclofenac) NH
ClCl
O
O
(A) 100 mg
MM 0181.01 Imp. D (EP): Methyl [[[2-[(2,6-Dichloro-phenyl)amino]phenyl]acetyl]oxy]- acetate (Methyl Ester of Aceclofenac) NH
ClCl
O
OO
O (A) 100 mg
MM 0181.02 Imp. E (EP): Ethyl [[[2-[(2,6-Dichlorophenyl)amino]phenyl] acetyl]oxy]acetate (Ethyl Ester of Aceclofenac)
NHClCl
O
OO
O (A) 100 mg
MM 0181.03 Imp. F (EP): Benzyl[[[2-[(2,6-Dichlorophenyl)amino]phenyl] acetyl]oxy]acetate (Benzyl Ester of Aceclofenac)
NHClCl
O
OO
O (A) 100 mg
MM 0181.04 Imp. G (EP): [[[[[2-[(2,6-Dichlorophenyl)amino]phenyl]- acetyl]oxy]acetyl]oxy]acetic Acid (Acetic Aceclofenac)
NHClCl
O
OO
OOH
O
(A) 100 mg
MM 0006.01 Imp. I (EP):1-(2,6-Dichlorophenyl)-1,3-dihydro-2H-indol-2-one
ClClN
O(A) 100 mg
MM 0181.05 Imp. H (EP): [[[[[[[2-[(2,6-Dichlorophenyl)-amino]phenyl]acetyl]oxy]acetyl]oxy]acetyl]-oxy]acetic Acid (Diacetic Aceclofenac)
NHClCl
O
O
O
O
O
O
OH
O (A) 50 mg
MM 0181.06 Isopropyl [2-[(2,6-Dichlorophenyl)amino]phenyl]acetate (Isopropyl Ester of Diclofenac) NH
ClCl
O
O
(A) 100 mg
Acesulfame Potassium New MM 1093.01 Imp. A (EP): 3-Oxobutanamide (Acetylacetamide)
NH2
O
O
(A) 100 mg
Acetazolamide MM 0648.00 Acetazolamide
N N
S SNH2
HN
O
O O (A) 500 mg
New MM 0648.04 Imp. A (EP): N-(5-Chloro-1,3,4-thiadiazol-2- yl)acetamide
NN
SClHN
O
(A) 50 mg
Pharmaceutical impurities
12 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
New MM 0648.01 Imp. B (EP): N-(1,3,4-Thiadiazol-2-yl)acetamide NN
S HN
O
(A) 100 mg
Acetylcysteine MM 0024.00 N-Acetyl-L-cysteine
HS OH
O
HN
O
(A) 500 mg
MM 0024.03 Imp. A (EP): L-Cystine S OH
O
NH2
SHO
O
NH2 (B) 100 mg
MM 0024.02 Imp. B (EP): L-Cysteine HS OH
O
NH2
(B) 100 mg
MM 0024.04 Imp. C (EP): N,N’-Diacetyl-L-cystine
S OH
O
HN
SHO
O
NH
O
O (A) 100 mg
MM 0024.01 Imp. D (EP): N,S-Diacetyl-L-cysteine S OH
O
HN
O
O (A) 100 mg
MM 0024.05 Sodium 2-Methyl-4,5-dihydro-1,3-thiazol-4-carboxylate N
S
ONa
O (A) 100 mg
MM 0024.06 N-Propionyl-L-cysteine HS OH
O
HN
O
(A) 100 mg
Acetylsalicylic Acid MM 0133.00 Acetylsalicylic Acid O
HO OO (A) 500 mg
MM 0045.01 Imp. A (EP): 4-Hydroxybenzoic Acid HO
OH
O (B) 100 mg
MM 0045.02 Imp. B (EP): 4-Hydroxybenzene-1,3-dicarboxylic Acid (4-Hydroxyisophthalic Acid) HO
OH
O
OH
O (A) 100 mg
MM 0045.00 Imp. C (EP): Salicylic Acid OH
O
OH
(A) 500 mg
MM 0133.01 Imp. D (EP): 2-[[2-(Acetyloxy)benzoyl]oxy]benzoic Acid (Acetylsalicylsalicylic Acid)
O
O
OH
O
O
O
(A) 100 mg
MM 0133.03 Imp. E (EP):2-[(2-Hydroxybenzoyl)oxy]benzoic Acid (Salicylsalicylic Acid)
O
O
OH
O
OH
(A) 100 mg
MM 0133.02 Imp. F (EP): 2-(Acetyloxy)benzoic Anhydride (Acetylsalicylic Anhydride)
O
O
O
O O O
O (A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 13
Code Product Code Unit
MM 0133.04 2-(2,4-Dihydroxybenzoyl)benzoic Acid OH
O
O
OH
OH
(A) 100 mg
N-Acetyltryptophan MM 1267.01 Imp. A (EP): Tryptophan H
N
O
OHNH2
(A) 100 mg
MM 0172.03 Imp. D (EP): (S)-2-Amino-3-(5-hydroxy- 1H-indol-3-yl)propanoic Acid (5-Hydroxy- tryptophan)
HN
O
OH
NH2
HO
(A) 100 mg
Aciclovir MM 0061.00 Aciclovir
N
HN N
N
O
H2NO
OH
(A) 500 mg
MM 0061.01 Imp. A (EP): 2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy]ethyl Acetate
N
HN N
N
O
H2NO
OO
(A) 100 mg
MM 0061.02 Imp. B (EP): 2-Amino-1,7-dihydro-6H-purin-6-one (Guanine)
N
HNHN
N
O
H2N
(B) 100 mg
MM 0061.04 Imp. D (EP): 2-[(2-Amino-6-oxo-1,6-dihydro-9H-purin-9-yl)methoxy]ethyl Benzoate
N
HN N
N
O
H2NO
OO
(A) 100 mg
MM 0061.06 Imp. F (EP): N-[9-[(2-Hydroxyethoxy)methyl]-6-oxo-6,9-dihydro-1H-purin-2-yl]acetamide
N
HN N
N
O
NH O
OHO
(A) 100 mg
MM 0061.07 Imp. G (EP): 2-[[(2-(Acetylamino)-6-oxo-1,6-dihydro-9H-purin-9-yl]methoxy]ethyl Acetate
N
HN N
N
O
NH O
OO O(A) 100 mg
MM 0061.08 Imp. H (EP): 2-[[2-(Acetylamino)-6-oxo-1,6-dihydro-9H-purin-9-yl]methoxy]ethyl Benzoate
N
HN N
N
O
NH O
OO
O
(A) 100 mg
MM 0061.10 2,6-Dichloropurine
N
N N
NH
Cl
Cl
(B) 100 mg
Adalapene New MM 0681.03 Imp. A (EP): 2,2'-Binaphthalene-6,6'-dicarboxylic Acid
HO
O
O
OH
(A) 50 mg
New MM 0681.01 Imp. C (EP): 1-(2-Methoxyphenyl)tricyclo- [3.3.1.1
3,7
]decane
O (A) 50 mg
Pharmaceutical impurities
14 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Adenosine MM 0784.00 Adenosine
N
NN
N
NH2
OHO
OH OH
(A) 500 mg
New MM 0784.01 Imp. A (EP) as Sulphate: 7H-Purin-6-amine Sulphate (Adenine Sulphate)
NH
NN
N
NH2
2
x H2SO4
(A) 100 mg
New MM 0784.02 Imp. F (EP): 1-�-D-Ribofuranosylpyrimidine- 2,4(1H,3H)-dione (Uridine)
NO
HO
OH OH
HN
O
O
(A) 100 mg
New MM 0784.03 Imp. G (EP): 9-�-D-Ribofuranosyl-1,9-dihydro- 6H-purin-6-one (Inosine)
N
NHN
N
O
OHO
OH OH
(A) 100 mg
New MM 0784.04 Imp. H (EP): 2-Amino-9-�-D-ribofuranosyl- 1,9-dihydro-6H-purin-6-one (Guanosine)
N
NHN
N
O
OHO
OH OH
H2N
(A) 100 mg
Adiphenine Hydrochloride MM 1172.00 Adiphenine Hydrochloride
O
O
Nx HCl
(A) 250 mg
Adrenaline Tartrate MM 0614.00 Adrenaline Tartrate
OHHO
OH HN
HOOH
OHOH
O
O
x
(A) 500 mg
MM 0614.02 L-Adrenaline
OHHO
OH HN
(A) 500 mg
MM 0614.13 Imp. C (EP) as Hydrochloride: 1-(3,4-Di- hydroxyphenyl)-2-(methylamino)ethanone Hydrochloride (Adrenalone Hydrochloride)
HO
OHNHO x HCl
(A) 100 mg
MM 0614.01 (1R)-1-(3,4-Dihydroxyphenyl)-2-methylaminoethanesulphonic Acid(Adrenaline �-Sulphonate)
OH
HO
HN
SO3H (A) 100 mg
Alanine MM 0566.00 Alanine
OH
O
NH2 (A) 500 mg
Albendazole MM 0382.00 Albendazole
N
HN
SNH
OO (A) 500 mg
MM 0382.01 Imp. A (EP): 5-(Propylsulphanyl)-1H-benzimidazol-2-amine
N
HN
S
NH2
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 15
Code Product Code Unit
MM 0382.02 Imp. B (EP): Methyl [5-Propylsulphinyl)-1H-benzimidazol-2-yl]carbamate
N
HN
SNH
OO
O
(A) 100 mg
MM 0382.03 Imp. C (EP): Methyl [5-Propylsulphonyl)-1H-benzimidazol-2-yl]carbamate
N
HN
SNH
OO
OO
(A) 100 mg
MM 0382.04 Imp. D (EP): 5-(Propylsulphonyl)-1H-benzimidazol-2-amine N
HN
SNH2
OO
(A) 100 mg
MM 2500.00 Imp. E (EP): Methyl (1H-Benzimidazol-2-yl)carbamate (Carbendazim)
N
HN
NHO
O (A) 100 mg
Alfuzosin Hydrochloride MM 0085.04 Imp. B (EP): 2-Chloro-6,7-dimethoxyquinazolin-4-amine
N
NO
O
NH2
Cl (A) 100 mg
New MM 1004.04 Imp. D (EP) as Dihydrochloride: N- (4-Amino-6,7-dimethoxyquinazolin- 2-yl)-N-methylpropane-1,3- diamine Dihydrochloride
N
NO
O
NH2
N NH2
x 2 HCl
(A) 50 mg
Allobarbital MM 0899.00 Allobarbital
[Controlled Substance]NH
HN OO
O
(A) 100 mg
Allopurinol MM 0034.00 Allopurinol
NH
NNH
N
O (A) 500 mg
MM 0034.01 Imp. A (EP) as Hemisulphate: 5-Amino-1H-pyrazole-4-carboxamide Hemisulphate NH2
NH2NH
N
O
x 1/2 H2SO4
(A) 100 mg
MM 0034.05 Imp. D (EP): Ethyl 5-Amino1H-pyrazole-4-carboxylate O
NH2NH
N
O (A) 100 mg
MM 0034.06 Imp. E (EP): Ethyl 5-(Formylamino)-1H-pyrazole-4-carboxylate O
NH
NH
N
O
O
(A) 100 mg
MM 0034.07 Oxypurinol
NH
NHN
NH
O
O
(A) 100 mg
Alprazolam MM 0028.03 Imp. E (EP): (2-Amino-5-chlorophenyl)phenylmethanone
OCl
NH2 (B) 100 mg
Alverine Citrate MM 0454.00 Alverine Citrate
N
OHO
OHO
OHO
OH
x
(A) 250 mg
MM 0454.02 Imp. A (EP): 1-Chloro-3-phenyl-propane Cl
(A) 100 mg
MM 0454.03 Imp. B (EP): 3-Phenylpropan-1-ol OH
(A) 100 mg
Pharmaceutical impurities
16 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0454.04 Imp. C (EP) as Hydrochloride: N-Ethyl- 3-phenylpropan-1-amine Hydrochloride NH
x HCl (A) 100 mg
MM 0454.05 Imp. D (EP) as Hydrochloride: N-(3- Cyclohexylpropyl)-N-ethyl-3-phenyl- propan-1-amine Hydrochloride
Nx HCl (A) 100 mg
MM 0454.06 Imp. E (EP) as Hydrochloride: 3-Phenyl- N,N-bis(3-phenylpropyl)propan-1-amine Hydrochloride
N
x HCl
(A) 100 mg
Amantadine Hydrochloride MM 0564.00 Amantadine Hydrochloride NH2
x HCl
(A) 500 mg
Ambroxol Hydrochloride MM 0005.00 Ambroxol Hydrochloride
x HCl
BrNH2
BrNH
OH (A) 500 mg
MM 0005.01 Imp. A (EP): (2-Amino-3,5-dibromophenyl)methanol
BrNH2
BrOH (A) 100 mg
MM 0005.04 Imp. B (EP) as Hydrochloride: trans-4-(6,8-Dibromo-1,4-dihydroquinazolin-3(2H)-yl)cyclohexanol Hydrochloride
x HCl
BrNH
BrN
OH (A) 100 mg
MM 0005.03 Imp. C (EP): trans-4-[[(E)-2-Amino-3,5-dibromobenzyliden]amino]cyclohexanol
BrNH2
BrN
OH (A) 100 mg
MM 0005.05 Imp. D (EP) as Hydrochloride: cis-4-[(2-Amino-3,5-dibromobenzyl)amino]cyclohexanol Hydrochloride
x HCl
BrNH2
BrNH
OH (A) 100 mg
MM 0005.02 Imp. E (EP): 2-Amino-3,5-dibromobenzaldehyde
BrNH2
BrO (A) 100 mg
MM 0005.06 trans-4-Aminocyclohexanol Hydrochloride x HCl
H2N
OH (A) 100 mg
MM 0005.07 cis-4-Aminocyclohexanol Hydrochloride x HCl
H2N
OH (A) 100 mg
Amiloride Hydrochloride MM 0560.00 Amiloride Hydrochloride Dihydrate
N
NCl
NH2H2N
NH
O
NH2
NH
x HClx 2 H2O
(A) 500 mg
Aminocaproic Acid MM 0896.00 Aminocaproic Acid
H2NOH
O (A) 500 mg
Amiodarone Hydrochloride MM 0697.00 Amiodarone Hydrochloride O
O
I
I
ON
x HCl
(A) 250 mg
MM 0697.11 Imp. A (EP) as Oxalate: (2-Butylbenzofuran-3-yl) [4-[2-(diethylamino)ethoxy]- phenyl]methanone Oxalate
O
O
ON
HO O
OHO
x
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 17
Code Product Code Unit
MM 0697.03 Imp. B (EP) as Hydrochloride: (2-Butylbenzofuran-3-yl)[4- [2-(ethylamino)ethoxy]-3,5- diiodophenyl]methanone Hydrochloride (Desethylamiodarone Hydrochloride)
O
O
I
I
O
HN
x HCl
(D) 100 mg
MM 0697.04 Imp. C (EP) as Hydrochloride: (2-Butylbenzofuran-3-yl)[4-[2-(diethylamino)ethoxy]- 3-iodophenyl]methanone Hydrochloride
O
OI
ON
x HCl
(A) 100 mg
MM 0697.05 Imp. D (EP): (2-Butylbenzofuran-3-yl)(4-hydroxy-3,5-diiodophenyl)methanone
O
O
I
I
OH
(A) 100 mg
MM 0697.06 Imp. E (EP): (2-Butylbenzofuran-3-yl)(4-hydroxyphenyl)methanone
O
O
OH
(A) 100 mg
MM 0697.07 Imp. F (EP): (2-Butylbenzofuran-3-yl)(4-hydroxy-3-iodophenyl)methanone
O
OI
OH
(A) 100 mg
MM 0697.09 Imp. H (EP) as Hydrochloride: 2-Chloro-N,N-diethylethanamine Hydrochloride (2-Chlorotriethylamine Hydrochloride; (2-Chloroethyl)diethylamine Hydrochloride)
ClN
x HCl(C) 100 mg
MM 0697.10 Amiodarone N-Oxide Hydrochloride O
O
I
I
ON
x HClO
(A) 100 mg
Amisulpride MM 0051.01 Imp. A (EP): [(2RS)-1-Ethylpyrrolidin-2-yl]methanamine H2N
N(A) 100 mg
New MM 0793.03 Imp. C (EP): 4-Amino-N-[[(2RS)-1-ethyl- pyrrolidin-2-yl]methyl]-5-iodo-2-methoxy- benzamide
I
H2N O
NH
O
N
(A) 50 mg
New MM 0793.04 Imp. D (EP): 4-Amino-N-[[(2RS)-1-ethyl- pyrrolidin-2-yl]methyl]-2-methoxy-5- (methylsulphonyl)benzamide
SO O
H2N O
NH
O
N
(A) 50 mg
New MM 0793.05 Imp. E (EP): 4-Amino-5-(ethylsulphonyl)- 2-methoxybenzoic Acid S
O O
H2N O
OH
O (A) 100 mg
Amitraz MM 1018.01 Imp. A (BP): 2,4-Dimethylaniline
(2,4-Xylidine) NH2 (A) 100 mg
MM 1018.02 Imp. B (BP): Form-2',4'-xylidide HN O (A) 100 mg
Amitriptyline Hydrochloride MM 0062.00 Amitriptyline Hydrochloride
N x HCl
(A) 500 mg
MM 0062.01 Imp. A (EP): 10,11-Dihydro-5H-dibenzo- [a,d][7]annulen-5-one (Dibenzosuberone) O
(B) 100 mg
Pharmaceutical impurities
18 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0062.02 Imp. B (EP) as Hydrochloride: 3-(5H-Dibenzo[a,d][7]annulen-5-ylidene)-N,N-dimethylpropan-1-amine Hydrochloride (Cyclobenzaprine Hydrochloride) N x HCl
(A) 100 mg
MM 0079.00 Imp. C (EP) as Hydrochloride: 3-(10,11-Dihydro-5H-dibenzo[a,d][7]annulen-5-ylidene)-N-methylpropan-1-amine Hydrochloride (Nortriptyline Hydrochloride) N
H x HCl
(A) 500 mg
MM 0062.03 Imp. D (EP): 5-[3-(Dimethylamino)propyl]-10,11-dihydro-5H-dibenzo[a,d][7]annulen-5-ol OH N
(A) 100 mg
MM 0062.05 Imp. F (EP): (5EZ,10RS)-5-[3-(Dimethyl- amino)propylidene]-10,11-dihydro-5H- dibenzo[a,d][7]annulen-10-ol
HO
N(A) 100 mg
MM 0062.14 Imp. G (EP): 10,11-Dihydro-5H-dibenzo[a,d][7]annulen-5-ol (Dibenzosuberol) OH
(A) 100 mg
MM 0062.12 Amitriptyline N-Oxide Hydrochloride
N x HClO
(B) 10 mg
MM 0062.13 10,11-Dihydro-5H-dibenzo[a,d]cycloheptene (Dibenzosuberane) (A) 100 mg
Amlodipine Besilate MM 0383.00 Amlodipine Besilate H
N
O
O
O
O
ONH2
Cl
SO
O
OH
x
(D) 100 mg
MM 0383.06 Amlodipine HN
O
O
O
O
ONH2
Cl
(A) 100 mg
MM 0383.01 Imp. A (EP): 3-Ethyl-5-Methyl (4RS)-4-(2-Chlorophenyl)-2-[[2-(1,3-dioxo-1,3-dihydro-2H-isoindol-2-yl)ethoxy]methyl]-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
HN
O
O
O
O
O
Cl
N
O
O
(D) 100 mg
MM 0383.02 Imp. B (EP): 3-Ethyl 5-Methyl (4RS)-4-(2-Chlorophenyl)-6-methyl-2-[[2-[[2-(methylcarbamoyl)benzoyl]amino]-ethoxy]methyl]-1,4-dihydropyridine-3,5-dicarboxylate
HN
O
O
O
O
OHN
Cl
O
NH
O(D) 100 mg
MM 0383.03 Ethyl Methyl (4RS)-2,6-Bis[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-1,4-dihydropyridine-3,5-dicarboxylate Dihydrochloride
HN
O
O
O
O
ONH2
Cl
OH2N
x 2 HCl
(D) 100 mg
MM 0383.04 Imp. D (EP): 3-Ethyl-5-Methyl 2-[(2-Aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methylpyridine-3,5-dicarboxylate
N
O
O
O
O
ONH2
Cl
(D) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 19
Code Product Code Unit
MM 0383.10 Imp. E (EP): Diethyl (4RS)-2-[(2-Amino- ethoxy)methyl]-4-(2-chlorophenyl)-6- methyl-1,4-dihydropyridine-3,5-dicarboxylate
HN
O
O
O
O
ONH2
Cl
(D) 100 mg
MM 0383.07 Imp. G (EP): Dimethyl 4-(2-Chlorophenyl)- 2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate
HN
O
O
O
OCl
(A) 100 mg
MM 0383.11 Imp. H (EP): 2-[[2-[[(4RS)-4-(2-Chlorophenyl)- 3-(ethoxycarbonyl)-5-(methoxycarbonyl)-6- methyl-1,4-dihydropyridin-2-yl]methoxy]ethyl]- carbamoyl]benzoic Acid
HN
O
O
O
O
OHN
Cl
OOHO
(D) 100 mg
MM 0383.05 Benzenesulfonic Acid SO
O
OH(B) 100 mg
Amlodipine Maleate MM 0631.00 Amlodipine Maleate H
N
O
O
O
O
ONH2
Cl
O
OH
O
OHx
(D) 100 mg
Amlodipine Mesilate MM 0592.00 Amlodipine Mesilate H
N
O
O
O
O
ONH2
Cl
SHO
xO O
(D) 100 mg
Amodiaquine Dihydrochloride Dihydrate MM 0617.00 Amodiaquine Dihydrochloride Dihydrate NCl
HN
OH
N x 2 HClx 2 H2O
(A) 500 mg
MM 0617.01 4-Acetamido-2-diethylaminomethylphenol
OH
N
O
HN
(A) 100 mg
MM 0617.02 7-Chloro-4-(4-hydroxyphenylamino)quinoline NCl
HN
OH
(A) 100 mg
MM0617.03 4,7-Dichloroquinoline NCl
Cl
(C) 100 mg
MM 0617.04 Monodesethylamodiaquine Dihydrochloride NCl
HN
OH
HNx 2 HCl
(A) 100 mg
Amoxicillin Trihydrate MM 0232.00 Amoxicillin Trihydrate
N
S
OHO
H
O
HN
HO
NH2
O
x 3 H2O
(A) 500 mg
Pharmaceutical impurities
20 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0026.04 Imp. A (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid (6-Aminopenicillanic Acid) N
S
OHO
H
O
H2N
(B) 100 mg
New MM 0232.02 Imp. B (EP): (2S,5R,6R)-6-[[(2S)-2-Amino- 2-(4-hydroxyphenyl)acetyl]amino]-3,3- dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]- heptane-2-carboxylic Acid (L-Amoxicillin)
N
S
OHO
H
O
HN
HO
NH2
O
(D) 100 mg
MM 0232.03 Imp. C (EP): (4S)-2-[5-(4-Hydroxyphenyl)-3,6-dioxopiperazin-2-yl]-5,5-dimethyl-thiazolidine-4-carboxylic Acid (Amoxicillin Diketopiperazines) H
N S
HN
OHO
NH
HO
O
O
(A) 100 mg
MM 0232.04 Imp. D (EP) as Sodium Salt:(4S)-2-[[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]-carboxymethyl]-5,5-dimethylthiazolidine-4-carboxylic Acid Sodium Salt (Penicilloic Acids of Amoxicillin Sodium Salt)
HN
HO
NH2
O
S
HN
ONaO
OHO
(A) 100 mg
MM 0232.05 Imp. E (EP): (2RS,4S)-2-[[[(2R)-2-Amino-2-(4-hydroxyphenyl)acetyl]amino]methyl]-5,5-dimethylthiazolidine-4-carboxylic Acid (Penilloic Acids of Amoxicillin)
HN
HO
NH2
O
S
HN
OOH (A) 50 mg
MM 0232.06 Imp. F (EP): 3-(4-Hydroxyphenyl)pyrazin-2-ol N
N
HO
HO (A) 100 mg
MM 0232.08 Imp. H (EP): (2R)-2-[(2,2-Dimethylpropanoyl)amino]-2- (4-hydroxyphenyl)acetic Acid
HO
NH
O
O
OH
(A) 100 mg
MM 0232.09 Imp. I (EP): (2R)-2-Amino-2-(4-hydroxyphenyl)acetic Acid
HO
NH2
OH
O
(B) 100 mg
MM 0232.12 (2R)-2-Amino-2-(4-hydroxyphenyl)acetamide
HO
NH2NH2
O
(A) 100 mg
Ampicillin Sodium MM 0253.00 Ampicillin Sodium
N
S
ONaO
H
O
HN
NH2
O
(A) 500 mg
MM 0253.15 Ampicillin Trihydrate
N
S
OOH
H
O
HN
NH2
O
x 3 H2O
(A) 500 mg
MM 0026.04 Imp. A (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid (6-Aminopenicillanic Acid) N
S
OHO
H
O
H2N
(B) 100 mg
MM 0253.02 Imp. B (EP): (2S,5R,6R)-6-[[(2S)-2-Amino-2-phenylacetyl]amino]-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid (L-Ampicillin) N
S
OOH
H
O
HN
NH2
O
(A) 100 mg
MM 0253.03 Imp. C (EP): (4S)-2-(3,6-Dioxo-5-phenylpiperazin-2-yl)-5,5-dimethylthiazolidine-4-carboxylic Acid (Diketopiperazines of Ampicillin) H
N S
HN
OOH
NH
O
O
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 21
Code Product Code Unit
MM 0253.04 Imp. D (EP) as Sodium Salt: (4S)-2-[[[(2R)-2-Amino-2-phenylacetyl]amino]-carboxymethyl]-5,5-dimethylthiazolidine-4-carboxylic Acid Sodium Salt (Penicilloic Acids of Ampicillin Sodium Salt)
HN
NH2
O
S
HN
ONaO
OHO
(A) 100 mg
MM 0253.06 Imp. F (EP): (2RS,4S)-2-[[[(2R)-2-Amino-2-phenylacetyl]amino]methyl]-5,5-dimethyl-thiazolidine-4-carboxylic Acid (Penilloic Acids of Ampicillin) H
N
NH2
O
S
HN
OOH (A) 100 mg
MM 0253.11 Imp. K (EP): (2R)-2-[(2,2-Dimethylpropanoyl)amino]-2-phenylacetic Acid
O
OH
NH
O (A) 100 mg
MM 0253.08 Imp. H (EP): 3-Phenylpyrazin-2-ol N
NHO (A) 100 mg
MM 0253.12 Imp. L (EP): (2R)-2-Amino-2-phenylacetic Acid (D-Phenylglycine)
O
OHNH2 (B) 100 mg
MM 0253.16 Ampicillin, anhydrous
N
S
OOH
H
O
HN
NH2
O
(A) 500 mg
Androstanolone MM 0565.00 Androstanolone
O
OH (A) 250 mg
Anise Oil MM 0164.01 trans-Anethole
O
(C) 100 mg
MM 0164.02 Estragole O
(C) 100 mg
MM 0164.03 AnisaldehydeO
O (C) 100 mg
MM 0164.05 Linalol
HO
(C) 100 mg
MM 0164.06 cis-Anethole O
(D) 100 mg
Antazoline Hydrochloride MM 0171.00 Antazoline Hydrochloride
N NH
N x HCl
(A) 500 mg
MM 0171.01 Imp. A (EP) as Dihydrochloride: N-(2-Aminoethyl)-2-(benzylphenylamino)acetamide Dihydrochloride
NNH
ONH2
x 2 HCl
(A) 100 mg
MM 0171.03 N-Benzylaniline NH (B) 100 mg
MM 0171.04 Imp. B (Pharmeuropa) as Hydrochloride: 2-(Chloro- methyl)-4,5-dihydro-1H-imidazole Hydrochloride
Cl
NH
N
x HCl(A) 100 mg
Pharmaceutical impurities
22 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Antazoline Phosphate MM 0561.00 Antazoline Phosphate
NN
HN
x H3PO4
(A) 500 mg
Apomorphine Hydrochloride MM 0562.00 Apomorphine Hydrochloride Hemihydrate
N
OHHO
H
x HClx ½ H2O
(A) 250 mg
MM 0037.00 Imp. B (EP) as Hydrochloride Trihydrate: Morphine Hydrochloride Trihydrate [Controlled Substance]
O OHHO
N
x HClx 3 H2O
(A) 250 mg
Aprindine Hydrochloride MM 0467.00 Aprindine Hydrochloride
N
N
HCl
on request
Arginine MM 0568.00 Arginine
OH
O
HNH2N
NH
NH2 (A) 500 mg
Arginine Hydrochloride MM 0569.00 Arginine Hydrochloride
OH
O
HNH2N
NH
NH2
x HCl(A) 500 mg
Articaine Hydrochloride MM 0369.00 Articaine Hydrochloride
HN
NHS
OO
O
x HCl
(A) 100 mg
MM 0369.01 Imp. A (EP) as Hydrochloride: Methyl 3-[[2-(Propylamino)acetyl]amino]-4-methylthiophene-2-carboxylate Hydrochloride (Acetamidoarticaine Hydrochloride)
x HClHN
NHS
OO
O
(A) 100 mg
MM 0369.02 Imp. B (EP) as Hydrochloride: 4-Methyl-3-[[(2RS)-2-(propylamino)propanoyl]amino]thiophene-2-carboxylic Acid Hydrochloride (Articaine Acid Hydrochloride)
x HClHN
NHS
OHO
O
(A) 50 mg
MM 0369.03 Imp. C (EP) as Hydrochloride: 1-Methylethyl 4-Methyl-3-[[(2RS)-2-(propylamino)propanoyl]amino]thiophene-2-carboxylate Hydrochloride (Articaine Isopropyl Ester Hydrochloride)
x HClHN
NHS
OO
O
(A) 100 mg
MM 0369.04 Imp. D (EP) as Hydrochloride: Methyl 3-[[(2RS)-2-(Ethylamino)propanoyl]amino]-4-methylthiophene-2-carboxylate Hydrochloride (Ethylarticaine Hydrochloride)
x HClHN
NHS
OO
O
(B) 10 mg
MM 0369.05 Imp. E (EP) as Hydrochloride: Methyl 4-Methyl-3-[[(2RS)-2-[(1-methylethyl)amino]propanoyl]amino]thiophene-2-carboxylate Hydrochloride (Isopropylarticaine Hydrochloride)
x HClHN
NHS
OO
O
(A) 100 mg
MM 0369.06 Imp. F (EP) as Hydrochloride: 4-Methyl-N-propyl-3-[[(2RS)-2-(propylamino)propanoyl]amino]thiophene-2-carboxamide Hydrochloride (Articaine Acid Propionamide Hydrochloride)
x HClHN
NHS
OHN
O
(A) 50 mg
MM 0369.07 Imp. G (EP) as Hydrochloride: Methyl 3-[[(2RS)-2-(Butylamino)propanoyl]amino]-4-methylthiophene-2-carboxylate Hydrochloride (Butylarticaine Hydrochloride)
x HClHN
NHS
OO
O
(A) 100 mg
MM 0369.08 Imp. H (EP) as Hydrochloride: Methyl 3-[[(2RS)-2-(Dipropylamino)propanoyl]amino]-4-methylthiophene-2-carboxylate Hydrochloride (Dipropylarticaine Hydrochloride)
x HClHN
NS
OO
O
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 23
Code Product Code Unit
MM 0369.09 Imp. I (EP): Methyl 3-Amino-4-methylthiophene-2-carboxylate (3-Aminoarticaine)
S
NH2
OO (C) 100 mg
MM 0369.10 Imp. J (EP): Methyl 3-[[(2RS)-2-Bromopropanoyl]amino]-4-methylthiophene-2-carboxylate (Bromo Compound)
HN
BrS
OO
O
(B) 10 mg
Ascorbic Acid MM 0166.00 L-Ascorbic Acid
OHO
OH
OHHO
O(A) 500 mg
Asparagine Monohydrate MM 0765.01 Phenylacetylasparagine
O
H2NOH
O
HN
O (C) 50 mg
Aspartame MM 0314.00 Aspartame H
NO
O
O
NH2
HO
O (A) 500 mg
MM 0314.01 Imp. A (EP): 2-(5-Benzyl-3,6-dioxopiperazin-2-yl)acetic Acid (Diketopiperazine)
NH
O
HN
HO
O
O (A) 100 mg
MM 0314.02 Imp. B (EP): L-Aspartyl-L-phenylalanine HN
OH
O
O
NH2
HO
O (A) 100 mg
MM 0314.03 Imp. C (EP): Phenylalanine H2N
OH
O (B) 100 mg
Aspartic Acid MM 0567.00 Aspartic Acid
OH
OHO
NH2O (A) 500 mg
New MM 0460.10 Imp. B (Pharmeuropa): (E)-Butenedioic Acid (Fumaric Acid) OH
OHO
O
(B) 100 mg
New MM 0566.00 Imp. D (Pharmeuropa): (S)-2-Aminopropanoic Acid (Alanine) OH
O
NH2 (A) 500 mg
New MM 0169.00 Imp. F (Pharmeuropa): (2S)-2,5-Diamino-5- oxopentanoic Acid (L-Glutamine) OH
O
NH2
H2N
O
(A) 500 mg
Astemizole MM 0184.00 Astemizole
NN
HN
NO
F (A) 250 mg
MM 0184.13 Desmethyl Astemizole Hydrochloride
NN
HN
NOH
F
x HCl
(B) 10 mg
Atenolol MM 0013.00 Atenolol
H2N
OO
OH HN
(A) 500 mg
MM 0013.03 Imp. A (EP): 2-(4-Hydroxyphenyl)acetamide H2N
OOH (B) 100 mg
Pharmaceutical impurities
24 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0013.05 Imp. B (EP): 2-[4-[(2RS)-2,3-Dihydroxypropoxy)phenyl]acetamide
H2N
OO
OHOH
(A) 100 mg
MM 0013.01 2-[4-[[(2RS)-Oxiran-2-yl]methoxy]phenyl]acetamide
H2N
OO
O (A) 100 mg
MM 0013.06 Imp. D (EP): 2-[4-[(2RS)-3-Chloro-2-hydroxypropoxy]phenyl]acetamide
H2N
OO
OHCl
(A) 50 mg
MM 0013.07 Imp. E (EP): 2,2'-[(2-Hydroxypropane-1,3- diyl)bis(oxy-4,1-phenylene)]diacetamide
H2N
OO
NH2
OO
OH (A) 50 mg
MM 0013.02 Imp. F (EP): 2,2'-[[(1-Methylethyl)- imino]bis[(2-hydroxypropane-3,1- diyl)oxy-4,1-phenylene]]diacetamide
H2N
OO
OHN
NH2
OO
OH (A) 50 mg
MM 0013.04 Imp. G (EP): 2-[4-[(2RS)-2-Hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]acetic Acid
HO
OO
OH HN
(A) 50 mg
MM 0013.08 Imp. H (EP): 2-[4-[(2RS)-2-Hydroxy-3-[(1-methylethyl)amino]propoxy]phenyl]acetonitrile O
OH HN
N
(A) 100 mg
MM 0013.13 4-Hydroxyphenylacetic Acid HO
OOH (B) 100 mg
Atorvastatin Calcium MM 0400.00 Atorvastatin Calcium
N
F
NH
O
O
OOH
OH
-
2
Ca2+
(D) 100 mg
MM 0400.12 Imp. G (Pharmeuropa) as Calcium Salt: (3R,5R)-7-[2-(4-Fluorophenyl)-3-phenyl-4- (phenylcarbamoyl)-5-(propan-2-yl)-1H-pyrrol-1-yl]-5-hydroxy-3-methoxyheptanoic Acid Calcium Salt (3-O-Methylatorvastatin Calcium Salt)
N
F
NH
O
O
OOH
O
-
2
Ca2+
(D) 100 mg
MM 0400.16 Imp. G (Pharmeuropa) as Lithium Salt: (3R,5R)-7- [2-(4-Fluorophenyl)-3-phenyl-4-(phenylcarbamoyl)- 5-(propan-2-yl)-1H-pyrrol-1-yl]-5-hydroxy-3-methoxy-heptanoic Acid Lithium Salt (3-O-Methylatorvastatin Lithium Salt)
N
F
NH
O
O
OLiOH
O
(D) 100 mg
MM 0400.01 Imp. H (Pharmeuropa): (2R,4R)-2-[2-[2-(4-Fluoro- phenyl)-3-phenyl-4-(phenylcarbamoyl)-5-(propan- 2-yl)-1H-pyrrol-1-yl]ethyl]-4-hydroxytetrahydro-2H-pyran-6-one (Atorvastatin Lactone)
N
F
NH
O O
OH
O (D) 100 mg
MM 0400.04 1,1-Dimethylethyl (4R-cis)-6-[2-[2-(4-Fluorophenyl)-5-(1-methylethyl)-3-phenyl-4-[(phenylamino)carbonyl]-1-H-pyrrol-1-yl]ethyl]-2,2-dimethyl-1,3-dioxane-4-acetate
NNH
O O OO
F
O
(A) 100 mg
MM 0400.05 1,1-Dimethylethyl (4R-cis)-6-Aminoethyl-2,2-dimethyl-1,3-dioxane-4-acetate O
O
O O
H2N
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 25
Code Product Code Unit
MM 0400.13 1-[2-[(2S)-3,6-Dihydro-6-oxo-2H-pyran-2-yl]-ethyl]-5-(4-fluorophenyl)-2-(1-methylethyl)-N,4-diphenyl-1H-pyrrole-3-carboxamide (Atorvastatin eliminated Lactone) N
F
NH
O O
O (A) 100 mg
Atracurium Besilate MM 0858.13 Imp. J (EP): Methyl Benzenesulphonate
SO
O O (A) 100 mg
Atropine MM 0289.18 Atropine
O
ON
OH
H
H
H
and enantiomer
(A) 250 mg
MM 0289.00 Atropine Sulphate
O
ON
OH
H
2and enantiomer
x H2SO4x H2O
H
H (A) 500 mg
MM 0289.01 Imp. A (EP) as Hydrochloride: (1R,3r,5S)-8-Methyl-8-azabicyclo[3.2.1]oct-3-yl 2-Phenylpropenoate Hydrochloride (Apoatropine Hydrochloride)
O
ON
H x HCl
H
H (D) 100 mg
MM 0601.03 Imp. C (EP): (2RS)-3-Hydroxy-2-phenylpropanoic Acid (Tropic Acid)
OH
OH
O (A) 100 mg
MM 0546.00 Imp. F (EP) as Hydrobromide Trihydrate: Hyoscine Hydrobromide Trihydrate
ON
OH
H
H
H
O
H
H
x HBrx 3 H2O
O(A) 500 mg
MM 0289.03 Atropic AcidOH
O (A) 100 mg
Avobenzone MM 0902.00 Avobenzone O O
O
(A) 500 mg
Azelaic Acid MM 0687.00 Azelaic Acid
HO OH
OO (A) 500 mg
Azelastine Hydrochloride MM 0362.00 Azelastine Hydrochloride
N
N
ON
Cl
x HCl
(A) 100 mg
MM 0362.04 Imp. A (EP): Benzoyldiazane (Benzohydrazide)NH
O
NH2
(C) 100 mg
MM 0362.02 Imp. B (EP) as Hydrochloride: 1-Benzoyl-2-[(4RS)-1-methylhexahydro-1H-azepin-4-yl]diazane Hydrochloride H
N
O
x HClNH
N(A) 100 mg
PRS - Pharmaceutical referencestandards traceable to USP, EP, BP
The concept of secondary standards derived by direct
comparison with pharmacopoeial reference standards
is a proven one and acknowledged by all major
regulation agencies and pharmacopoeias.
To source them from a dedicated provider instead
of producing them on your own offers some more
advantages.
Efficiency:
You can focus your resources on value producing
activities, rather than the routine.
Risk Mitigation:
These standards are supplied by an independent
3rd party Reference Material Producer accredited
according to ISO 17025 & ISO Guide 34.
Economical savings:
Attractively priced over pharmacopeial reference standards
or in-house standards.
Generous Quantities:
Product contains 2 - 20x the amount offered by the Pharmacopoeias,
allowing multiple uses.
Furthermore, every current Pharmaceutical Reference Standard is re-certified
after new pharmacopoeial lot or batch releases. Please contact your local
LGC Standards office to obtain updated certificates for the materials purchased.
www.lgcstandards.comNo part of this publication may be reproduced or transmitted in any form or byany means, electronic or mechanical, including photocopying, recording or anyretrieval system, without the written permission of the copyright holder. © LGC Standards, 2010. All rights reserved. 2593/SR/0510
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 27
Code Product Code Unit
MM 0362.05 Imp. C (EP): 2-[(4-Chlorophenyl)acetyl]benzoic Acid OH
O
O
Cl
(A) 100 mg
MM 0362.01 Imp. D (EP): 4-(4-Chlorobenzyl)phthalazin-1(2H)-one
N
NH
O
Cl
(A) 100 mg
MM 0362.06 Imp. E (EP) Z-Isomer: (Z)-3-(4-Chlorobenzylidene)-isobenzofuran-1(3H)-one O
O
Cl
(A) 100 mg
MM 0362.03 1-Methylazepan-4-one Hydrochloride O
N x HCl(A) 100 mg
Azithromycin New MM 1075.00 Azithromycin
O
HOOH
O
HO
O
O
OOH
N
O
N
O
OH
(A) 100 mg
MM 1075.01 Imp. A (EP): 6-Demethylazithromycin (Azaerythromycin A)
O
HOOH
O
HO
O
O
O
OHOO
N
OH
HN (D) 100 mg
Baclofen MM 1235.03 Imp. B (EP): (3RS)-5-Amino-3-(4-chlorophenyl)-
5-oxopentanoic Acid
Cl
OH
O
O
H2N
(A) 100 mg
MM 1235.01 3-(4-Chlorophenyl)glutaric Acid
Cl
OH
O
O
HO
(A) 100 mg
Bambuterol Hydrochloride MM 0773.04 Imp. D (EP): 5-[(1RS)-1-Hydroxyethyl]-1,3-phenylene
Bis(dimethylcarbamate) ON
O
O
OH
O
N
(A) 100 mg
MM 0773.05 Imp. E (EP): 5-Acetyl-1,3-phenylene Bis-(dimethylcarbamate) ON
O
O
O
O
N
(A) 100 mg
Basic Butylated Methacrylate Copolymer MM 0753.01 Imp. A (EP): Butyl Methacrylate O
O
(A) 100 mg
MM 0753.02 Imp. B (EP): Methyl Methacrylate O
O
(A) 100 mg
Pharmaceutical impurities
28 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0753.03 Imp. C (EP): 2-(Dimethylamino)ethyl Methacrylate O
ON
(A) 100 mg
Beclometasone Dipropionate MM 0199.00 Beclometasone Dipropionate
O
HO
O
O
O
Cl
O
O (A) 250 mg
MM 0199.02 Imp. A (EP): 9-Chloro-11�,17-dihydroxy-16�-methyl-3,20-dioxopregna-1,4-dien-21-yl Propanoate (Beclometasone 21-Propionate)
O
HO
Cl
OH
OO
O (A) 100 mg
MM 0199.06 Imp. B (EP): 21-(Acetyloxy)-9-chloro-11�-hydroxy-16�-methyl-3,20-dioxopregna-1,4- dien-17-yl Propanoate (Beclometasone 21- Acetate 17-Propionate)
O
HO
Cl
O
OO
O
O
(A) 100 mg
MM 0199.05 Imp. C (EP): 9-Chloro-11�-hydroxy-16�-methyl- 3,20-dioxo-17-(propanoyloxy)-pregna-1,4-dien- 21-yl Butanoate (Beclometasone 21-Butyrate 17-Propionate)
O
HO
Cl
O
OO
O
O
(A) 100 mg
MM 0199.01 Imp. H (EP): 9-Chloro-11�,21-dihydroxy-16�-methyl-3,20-dioxopregna-1,4-dien-17-yl Propanoate (Beclometasone 17-Propionate)
O
HO
Cl
O
OOHO (A) 100 mg
MM 0199.03 9-Chloro-11�,17,21-trihydroxy-16�-methylpregna- 1,4-diene-3,20-dione (Beclometasone)
O
HO
Cl
OH
OOH (A) 100 mg
Benazepril Hydrochloride New MM 1229.00 Benazepril Hydrochloride
N
OOH
O
HN
OO
x HCl
(A) 100 mg
Bendroflumethiazide MM 0674.01 Imp. A (EP): 4-Amino-6-(trifluoromethyl)benzene-1,3-disulphonamide S S
NH2
H2NO
FF
F
O ONH2
O (A) 100 mg
Benfluorex Hydrochloride New MM 0278.01 Imp. C (EP): Benzoic Acid
HO
O (B) 100 mg
Benperidol MM 0113.00 Benperidol
F
ON
NHN
O (A) 100 mg
MM 0113.03 Imp. A (EP): 1-(Piperidin-4-yl)-1,3-dihydro-2H-benzimidazol-2-one
HN
NHN
O (A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 29
Code Product Code Unit
MM 0113.07 4-Chloro-4'-fluorobutyrophenone
F
OCl
(B) 100 mg
Benzalkonium Chloride MM 0224.00 Benzalkonium Chloride
N
Cl
n
(A) 500 mg
MM 0795.00 Imp. A (EP): Benzyl Alcohol OH
(A) 500 mg
MM 0224.01 Benzyldimethyldodecylammonium Chloride N
Cl
5
(A) 500 mg
MM 0224.02 Benzyldimethyltetradecylammonium Chloride N
Cl
6
(A) 500 mg
MM 0224.03 Benzyldimethylhexadecylammonium Chloride N
Cl
7
(A) 500 mg
BenzbromaroneMM 0456.00 Benzbromarone O
OBr
OHBr
(A) 500 mg
Benzocaine MM 0094.00 Benzocaine
H2N
O
O (A) 500 mg
MM 0094.01 Benzocaine Acetylsalicylamide
NH
O
O
O
O
O
(C) 50 mg
MM 0094.02 N-Acetylbenzocaine
NH
O
O
O
(A) 100 mg
MM 0094.03 4-Aminobenzoic Acid
H2N
OH
O (B) 100 mg
MM 0094.04 Ethyl 4-Nitrobenzoate
O2N
O
O (B) 100 mg
Benzydamine Hydrochloride MM 0142.00 Benzydamine Hydrochloride
NN
O N
x HCl
(A) 500 mg
MM 0142.04 Imp. C (BP): 1-Benzyl-1H-indazol-3-ol N
N
OH
(A) 100 mg
MM 0142.08 Benzydamine N-Oxide Hydrochloride N
N
O N
x HCl
O
(A) 100 mg
MM 0290.02 1-Chloropropyl(dimethyl)amine Hydrochloride (N,N-Dimethyl-3-chloropropylamine Hydrochloride)
Cl N x HCl (B) 100 mg
Benzyl Alcohol MM 0795.00 Benzyl Alcohol
OH(A) 500 mg
Pharmaceutical impurities
30 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0795.02 Imp. B (EP): Cyclohexylmethanol OH (A) 100 mg
Benzyl Benzoate MM 0570.00 Benzyl Benzoate
O
O (A) 500 mg
Benzyl Nicotinate MM 0104.00 Benzyl Nicotinate
N O
O (A) 500 mg
MM 0553.00 Nicotinic Acid N OH
O (A) 500 mg
Benzylpenicillin Benzathine MM 0513.00 Benzylpenicillin Benzathine
N
SH
O
OOH
HN
NH
2
x HN
O
(A) 500 mg
MM 0513.02 Imp. A (EP): Monobenzylethylendiamine HNNH2 (C) 100 mg
MM 0160.03 Imp. B (EP): Phenylacetic Acid [Drug Precursor] OH
O
(B) 100 mg
MM 0160.07 Imp. D (EP): (3S,7R,7aR)-5-Benzyl-2,2-dimethyl-2,3,7,7a-tetrahydroimidazo[5,1-b]-thiazole-3,7-dicarboxylic Acid (Penillic Acid of Benzylpenicillin)
N
S
OOH
N
OHO
H
(A) 100 mg
MM 0160.01 Imp. E (EP): (4S)-2-[Carboxy[(phenylacetyl)amino]methyl]-5,5-dimethylthiazolidine-4-carboxylic Acid (Penicilloic Acids of Benzylpenicillin)
HN
S
OOH
HN
OO OH
(A) 100 mg
MM 0160.05 Imp. F (EP): (2RS,4S)-2-[[(Phenylacetyl)amino]methyl]-5,5-dimethylthiazolidine-4-carboxylic Acid (Penilloic Acids of Benzylpenicillin)
HN
S
OOH
HN
O
(A) 100 mg
MM 0513.01 N,N’-Dibenzylethylenediamine Diacetate
HO
Ox
2
HN
NH
(C) 100 mg
Benzylpenicillin Potassium MM 0160.00 Benzylpenicillin Potassium
N
SH
O
NH
O
OOK (A) 250 mg
MM 0026.04 Imp. A (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid (6-Aminopenicillanic Acid)
N
SH
O
H2N
OOH (B) 100 mg
MM 0160.03 Imp. B (EP): Phenylacetic Acid [Drug Precursor] O
OH
(B) 100 mg
MM 0160.07 Imp. D (EP): (3S,7R,7aR)-5-Benzyl-2,2-dimethyl-2,3,7,7a- tetrahydroimidazo[5,1-b]-thiazole-3,7-dicarboxylic Acid (Penillic Acid of Benzylpenicillin)
N
S
OOH
N
OHO
H
(A) 100 mg
MM 0160.01 Imp. E (EP): (4S)-2-[Carboxy[(phenylacetyl)amino]methyl]-5,5-dimethyl-thiazolidine-4-carboxylic Acid (Penicilloic Acids of Benzylpenicillin)
HN
S
OOH
HN
OO OH
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 31
Code Product Code Unit
MM 0160.05 Imp. F (EP): (2RS,4S)-2-[[(Phenylacetyl)amino]methyl]-5,5-dimethylthiazolidine-4-carboxylic Acid (Penilloic Acids of Benzylpenicillin)
HN
S
OOH
HN
O
(A) 100 mg
Benzylpenicillin Procaine MM 0094.03 Imp. A (EP): 4-Aminobenzoic Acid
OH
H2N
O (B) 100 mg
MM 0160.01 Imp. B (EP): (4S)-2-[Carboxy[(phenyl- acetyl)amino]methyl]-5,5-dimethyl- thiazolidine-4-carboxylic Acid (Penicilloic Acids of Benzylpenicillin)
HN
S
OOH
HN
OO OH
(A) 100 mg
MM 0160.05 Imp. C (EP): (2RS,4S)-2-[[(Phenylacetyl)- amino]methyl]-5,5-dimethylthiazolidine-4- carboxylic Acid (Penilloic Acids of Benzylpenicillin)
HN
S
OOH
HN
O
(A) 100 mg
MM 0160.07 Imp. D (EP): (3S,7R,7aR)-5-Benzyl-2,2- dimethyl-2,3,7,7a-tetrahydroimidazo[5,1- b]thiazole-3,7-dicarboxylic Acid (Penillic Acid of Benzylpenicillin)
N
S
OOH
N
OHO
H
(A) 100 mg
MM 0160.03 Imp. E (EP): Phenylacetic Acid [Drug Precursor] OH
O
(B) 100 mg
Betahistine Dihydrochloride MM 0587.00 Betahistine Dihydrochloride N
HN
x 2 HCl(A) 500 mg
MM 0587.01 Imp. A (EP): 2-Ethenylpyridine (2-Vinylpyridine) N (C) 100 mg
MM 0587.02 Imp. B (EP): 2-(Pyridin-2-yl)ethanol (2-(2-Hydroxyethyl)pyridine) N OH (B) 100 mg
MM 0587.03 Imp. C (EP) as Trihydrochloride: N-Methyl-2-(pyridin-2-yl)-N-[2-(pyridin-2-yl)ethyl]ethanamine Trihydrochloride
N N Nx 3 HCl
(A) 100 mg
MM 0587.04 Imp. C (EP) as Trimesilate: N-Methyl-2-(pyridin-2-yl)-N-[2-(pyridin-2-yl)ethyl]ethanamine Trimesilate
N N Nx 3 S
OH
OO (A) 100 mg
Betaine Hydrochloride MM 0611.00 Betaine Hydrochloride
NOH
OCl
(A) 500 mg
Betamethasone MM 0200.00 Betamethasone
O
HO
F
OH
O
OH(A) 250 mg
MM 0213.00 Imp. A (EP): Dexamethasone
O
HO
F
OH
O
OH(A) 250 mg
MM 0200.01 Imp. B (EP): 21-Chloro-9-fluoro-11�,17-dihydroxy-16�-methylpregna-1,4-diene-3,20-dione (Clobetasol)
O
HO
F
OH
O
Cl(A) 100 mg
Pharmaceutical impurities
32 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Betamethasone Acetate MM 0201.00 Betamethasone Acetate
O
O
OHHO
F
O
O (A) 250 mg
MM 0200.00 Imp. A (EP): Betamethasone
O
O
OHHO
F
OH (A) 250 mg
MM 0445.00 Imp. B (EP): Dexamethasone Acetate
O
O
OHHO
F
O
O (A) 250 mg
MM 0201.03 Imp. C (EP): Betamethasone 11,21-Diacetate
O
O
F
OH
O
O
OO (A) 100 mg
Betamethasone Dipropionate MM 0200.00 Imp. A (Pharmeuropa): 9-Fluoro-11�,17,21-
trihydroxy-16�-methylpregna-1,4-diene-3,20- dione (Betamethasone)
O
HO
F
OH
OOH (A) 250 mg
MM 0202.00 Betamethasone Dipropionate
O
O
OHO
F
O
O
O
(A) 250 mg
MM 0202.04 Imp. C (Pharmeuropa): 9-Fluoro-11�,17- dihydroxy-16�-methyl-3,20-dioxopregna- 1,4-dien-21-yl Propanoate (Betamethasone 21-Propionate)
O
HO
F
OH
OO
O (A) 100 mg
MM 0199.00 Imp. E (Pharmeuropa): 9-Chloro-11�-hydroxy- 16�-methyl-3,20-dioxopregna-1,4-diene-17,21- diyl Dipropanoate (Beclometasone Dipropionate)
O
HO
Cl
O
OO
O
O
(A) 250 mg
Betamethasone Sodium Phosphate MM 0303.00 Betamethasone Sodium Phosphate
O
O
OHHO
F
O PO
ONaONa
on request
Betamethasone 17-Valerate MM 0203.00 Betamethasone 17-Valerate
O
O
OHO
F
OHO (A) 250 mg
MM 0200.00 Imp. A (EP): Betamethasone
O
HO
F
OH
OOH (A) 250 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 33
Code Product Code Unit
Betaxolol Hydrochloride MM 0436.01 Imp. A (EP) as Hydrochloride: (2RS)-
1-(4-Ethylphenoxy)-3-[(1-methylethyl)amino]-propan-2-ol Hydrochloride
O
OHHN x HCl
(A) 50 mg
MM 0027.10 Imp. B (EP): (2RS)-1-[4-(2-Hydroxyethyl)phenoxy]- 3-[(1-methylethyl)amino]propan-2-ol
HO
OOH
HN
(A) 100 mg
MM 0436.03 Imp. C (EP): 2-[[4-[2-(Cyclopropylmethoxy)-ethyl]phenoxy]methyl]oxirane
O
OO
(A) 50 mg
MM 0436.04 Imp. D (EP): 4-[2-(Cyclopropylmethoxy)ethyl]phenol
O
OH (A) 50 mg
MM 0436.05 Imp. E (EP) as Hydrochloride: (2RS)-1-[4-(2-Butoxyethyl)phenoxy]-3-[(1-methylethyl)amino]propan-2-ol Hydrochloride O
O
OHHN
x HCl
(A) 50 mg
New MM 0436.06 1-[4-(2-Cyclobutoxyethyl)phenoxy]-3-(isopropylamino)propan-2-ol Hydrochloride
O
OOH
HN
x HCl
(D) 50 mg
Bezafibrate MM 0063.00 Bezafibrate
Cl
NH
OO
OH
O (A) 500 mg
MM 0063.01 Imp. A (EP): 4-Chloro-N-[2-(4-hydroxyphenyl)ethyl]benzamide (4-Chlorobenzoyltyramine)
Cl
NH
OOH (A) 100 mg
MM 0063.03 Imp. B (EP): 4-Chlorobenzoic Acid
Cl
O
OH
(B) 100 mg
MM 0063.04 Imp. C (EP): Methyl 2-[4-[2-[(4-Chlorobenzoyl)amino]ethyl]phenoxy]- 2-methylpropanoate
Cl
NH
OO
O
O (A) 100 mg
MM 0063.02 Imp. D (EP): Ethyl 2-[4-[2-[(4-Chlorobenzoyl)amino]- ethyl]phenoxy]-2-methylpropanoate
Cl
NH
OO
O
O (A) 100 mg
MM 0063.05 Imp. E (EP): Butyl 2-[4-[2-[(4-Chlorobenzoyl)amino]- ethyl]phenoxy]-2-methylpropanoate
Cl
NH
OO
O
O (A) 100 mg
MM 0063.06 Tyramine H2N
OH (B) 100 mg
MM 0063.07 N,O-Bis-(4-chlorobenzoyl)tyramine
NH
O
OO
Cl
Cl (A) 100 mg
Bicalutamide MM 0894.00 Bicalutamide F
SO O
NH
O
OH
N
F
F F
(A) 100 mg
MM 0894.01 N-[4-Cyano-3-(trifluoromethyl)phenyl]-3-[(4-fluorophenyl)sulfinyl]-2-hydroxy-2-methylpropanamide F
SHN
O
HO
N
F
F FO (A) 50 mg
Pharmaceutical impurities
34 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Bifonazole MM 0318.00 Bifonazole
NN
(A) 500 mg
MM 0318.01 Imp. A (EP): (RS)-(Biphenyl-4-yl)phenylmethanol
OH
(A) 100 mg
MM 0015.02 Imp. C (EP): 1H-Imidazole (Imidazole) N
HN (B) 100 mg
MM 0318.03 Imp. D (EP) as Chloride: 1,3-Bis[(biphenyl-4-yl)phenylmethyl]-1H-imidazolium Chloride
N+
NCl-
(D) 100 mg
Bisacodyl MM 0031.00 Bisacodyl
N
O
O
O
O
(A) 500 mg
MM 0031.01 Imp. A (EP): 4,4'-(Pyridin-2-ylmethylene)diphenol
N
HO OH (A) 100 mg
MM 0031.04 Imp. B (EP): 2-[(RS)-(4-Hydroxyphenyl)(pyridin-2-yl)methyl]phenol
N
OH OH (A) 50 mg
MM 0031.02 Imp. C (EP): 4-[(RS)-(4-Hydroxyphenyl)(pyridin-2-yl)methyl]phenyl Acetate
N
HO O
O
(A) 100 mg
MM 0031.03 Imp. E (EP): 2-[(RS)-[4-(Acetyloxy)phenyl](pyridin-2-yl)methyl]phenyl Acetate
N
O
O
O
O
(A) 50 mg
MM 0054.01 4-[(RS)-(4-Hydroxyphenyl)(pyridin-2-yl)- methyl]phenyl Sodium Sulphate (4-[(Pyridin-2-yl)(4-hydroxyphenyl)methyl]- phenyl Sodium Sulphate) N
HO OS
ONa
O O
(A) 100 mg
MM 0054.02 2-[(RS)-(Pyridin-2-yl)[4-(sulphonatooxy)- phenyl]methyl]phenyl Disodium Sulphate (2,4'-[(Pyridin-2-yl)methylene]bisphenyl Bis(Sodium Sulphate)) N
O
OS
SNaO
ONa
O O
O O(D) 50 mg
Bisoprolol Fumarate MM 0460.00 Bisoprolol
OOH H
N
OO
(A) 100 mg
MM 0460.08 Bisoprolol Fumarate O
OHHN
OO
OH
HO
O
O
2
x
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 35
Code Product Code Unit
MM 0460.01 Imp. A (EP): (RS)-1-(4-Hydroxymethyl- phenoxy)-3-isopropylaminopropan-2-ol O
OHHN
OH
(A) 100 mg
MM 0460.07 Imp. B (EP): (RS)-1-Isopropylamino-3-[4-(2- propoxyethoxymethyl)phenoxy]propan-2-ol O
OHHN
OO
(A) 100 mg
MM 0460.15 Imp. C (EP): (RS)-1-[4-[4-(2-Hydroxy- 3-isopropylaminopropoxy) benzyl]-phenoxy]- 3-isopropylaminopropan-2-ol
O
OHHNO
HN
OH (A) 100 mg
MM 0460.21 Imp. G (EP): (2RS)-1-[4-[[(2-Isopropoxy- ethoxy)methoxy]methyl]phenoxy]-3-iso- propylaminopropan-2-ol
O
OHHN
O OO
(D) 100 mg
MM 0460.24 Imp. J (Pharmeuropa): (2RS)-3-[4-((2-Isopropoxy- ethoxy)methyl)phenoxy]-1,2-propanediol O
OH
OH
OO
(A) 100 mg
MM 0460.18 Imp. K (EP): 2-Isopropoxyethyl 4-[[(2RS)-2-Hydroxy-3-(isopropylamino)propyl]oxy]- benzoate (Bisoprolol Ester)
OOH
HN
O
O
O
(A) 100 mg
MM 0027.24 Imp. L (EP) as Hydrochloride: 4-[[(2RS)-2- Hydroxy-3-(isopropylamino)propyl]oxy]benz- aldehyde Hydrochloride (4-[(2RS)-2-Hydroxy- 3-[(1-methylethyl)amino]propoxy]benzaldehyde Hydrochloride)
OOH
HN
O
x HCl
(A) 100 mg
MM 0460.02 Imp. M (Pharmeuropa): 4-[(2-Isopropoxyethoxy)methyl]phenol OH
O
O(A) 100 mg
MM 0460.25 Imp. N (EP): [(2RS)-1-[4-[(2-Ethoxyethoxy)- methyl]phenoxy]-3-isopropylaminopropan-2-ol O
OHHN
O
O
(A) 100 mg
MM 0460.05 Imp. Q (EP): (2RS)-1-(Isopropylamino)-3-[4-(2- methoxyethoxy)methyl]phenoxypropan-2-ol O
OHHN
OO
(A) 100 mg
MM 0460.28 Imp. R (EP): (2RS)-1-(Isopropylamino)-3-(4- methylphenoxy)propan-2-ol O
OHHN
(A) 50 mg
MM 0460.14 Imp. S (EP): 4-Hydroxybenzaldehyde OH
O
(C) 100 mg
MM 0460.17 Imp. T (EP): 4-[(3-Isopropyl-2-oxo-1,3-oxazolidin-5- yl)methoxy]benzaldehyde (Bisoprolol Oxazolidinone- benzaldehyde) O N
O
O
O
(A) 50 mg
MM 0460.27 (2RS)-4-[2-Hydroxy-3-(isopropylamino)propoxy]- benzoic Acid Hydrochloride O
OHHN
O
HOx HCl
(A) 50 mg
MM 0460.16 Imp. U (EP): 5-[[4-(Hydroxymethyl)phenoxy]- methyl]-3-isopropyl-1,3-oxazolidin-2-one (Bisoprolol Oxazolidinonebenzylalcohol) O N
O
O
HO
(A) 50 mg
MM 0460.03 2-[4-(2-Isopropoxyethoxymethyl)phenoxymethyl]oxirane O
OO
O (A) 100 mg
MM 0460.06 4-Hydroxybenzyl Alcohol OH
HO(B) 100 mg
MM 0460.10 Fumaric Acid OH
HO
O
O (B) 100 mg
Pharmaceutical impurities
36 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
New MM 0460.23 (2RS)-1-[4-((2-Hydroxyethoxy)methyl)phenoxy]-3-(isopropylamino)-2-propanol NH2
O
O
(A) 50 mg
Boldenone MM 0864.00 Boldenone
O
OH (A) 100 mg
Brimonidine Tartrate New MM 1324.00 Brimonidine Tartrate
NH
Br
NH
NN
NHO
OH
OH
OH
O
O
x
(A) 100 mg
BromazepamMM 0064.00 Bromazepam
[Controlled Substance]N
HN
N
O
Br
(A) 100 mg
MM 0064.01 Imp. A (EP): (2-Amino-5-bromophenyl)(pyridin-2-yl)methanone Br
NH2
O
N
(A) 100 mg
MM 0064.02 Imp. B (EP): N-[4-Bromo-2-(pyridin-2- ylcarbonyl)phenyl]-2-chloroacetamide
Br
NH
O
N
OCl (A) 50 mg
MM 0064.09 Imp. C (EP): 7-Bromo-5-(6-methylpyridin-2-yl)-1,3-dihydro-2H-1,4-benzodiazepin-2-one
N
HN
N
O
Br
(A) 50 mg
MM 0064.04 Imp. D (EP): 3-Amino-6-bromo-4-(pyridin- 2-yl)quinolin-2(1H)-one
Br
HN
N
NH2
O (A) 50 mg
MM 0064.07 Imp. E (EP): 2-Bromo-N-[4-bromo-2-(pyridin- 2-ylcarbonyl)phenyl]acetamide
Br
NH
O
N
OBr (A) 50 mg
Bromhexine Hydrochloride MM 0065.00 Bromhexine Hydrochloride Br
Br
NH2
N x HCl
(A) 500 mg
MM 0005.01 Imp. A (EP): (2-Amino-3,5-dibromophenyl)methanol
BrNH2
BrOH (A) 100 mg
MM 0005.02 Imp. B (EP): 2-Amino-3,5-dibromobenzaldehyde
BrNH2
BrO (A) 100 mg
MM 0065.02 Imp. C (EP): N-(2-Aminobenzyl)-N-methylcyclohexanamine
NH2
N(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 37
Code Product Code Unit
MM 0065.03 Imp. D (EP) as Dihydrochloride: N-(2-Amino-5-bromobenzyl)-N-methylcyclohexanamine Dihydrochloride
NH2
N
Br
x 2 HCl
(A) 100 mg
MM 0065.01 N-(2-Nitrobenzyl)-N-cyclohexyl-N-methylamine
NO2
N(A) 100 mg
MM 0065.05 6,8-Dibromo-3-cyclohexyl-3,4-dihydro-2(1H)-quinazolinone Br
BrHN N
O
(A) 100 mg
MM 0065.09 Bromhexine N-Oxide Br
Br
NH2
NO
(A) 100 mg
Bromisoval MM 1128.01 Ethyl 2-Bromoisovalerate
Br
O
O (A) 100 mg
Brompheniramine Maleate MM 0060.00 Brompheniramine Maleate O
OH
O
OHx
N
Br
N
(A) 500 mg
MM 0090.00 Imp. A (EP) as Maleate: Chlorphenamine Maleate O
OH
O
OHx
N
Cl
N
(A) 500 mg
MM 1114.00 Imp. B (EP) as Maleate: Dexchlorpheniramine Maleate O
OH
O
OHx
N
Cl
N
(A) 100 mg
MM 0059.01 Imp. C (EP): (3RS)-N,N-Dimethyl-3-phenyl-3-(pyridin-2-yl)- propan-1-amine (Pheniramine) N
N
(A) 100 mg
MM 0059.00 Imp. C (EP) as Maleate: (3RS)-N,N-Dimethyl- 3-phenyl-3-(pyridin-2-yl)propan-1-amine Maleate (Pheniramine Maleate)
O
OH
O
OHx
N
N
(A) 100 mg
MM 0060.12 Brompheniramine N-Oxide N
Br
NO
on request
MM 0060.16 Desmethylbrompheniramine Maleate O
OH
O
OHx
N
Br
NH
(A) 100 mg
Buclizine Hydrochloride MM 0380.04 Imp. A (BP): 1,4-Bis(4-chlorobenzhydryl)piperazine
(1,4-Bis[(4-chlorophenyl)phenylmethyl]piperazine)
NN
Cl
Cl
(A) 100 mg
Pharmaceutical impurities
38 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0380.09 4-Chlorobenzhydrol OH
Cl (B) 100 mg
MM 0380.10 4-Chlorobenzophenone O
Cl (B) 100 mg
MM 0380.01 1-(4-Chlorobenzhydryl)piperazine((RS)-1-[(4-Chlorophenyl)phenylmethyl]piperazine)
NH
N
Cl (A) 100 mg
Budesonide MM 0204.01 Imp. A (EP): 11�,16�,17,21-Tetrahydroxy-
pregna-1,4-diene-3,20-dione (16�-Hydroxy- prednisolone)
O
HO
OH
O
OH OH(A) 100 mg
New MM 0204.02 Imp. B (EP): 16�,17-[(1RS)-Ethylidenebis(oxy)]- 11�,21-dihydroxypregna-1,4-diene-3,20-dione
O
HO
O
OOH
O
(A) 50 mg
Bufexamac MM 0179.00 Bufexamac
O
HN
OHO
(A) 500 mg
MM 0179.01 Imp. A (EP): 2-(4-Butoxyphenyl)acetic Acid O
OH
O
(A) 100 mg
MM 0179.02 Imp. B (EP): Methyl 2-(4-Butoxyphenyl)acetate O
O
O
(A) 100 mg
MM 0179.03 Imp. C (EP): Butyl 2-(4-Butoxyphenyl)acetate O
O
O
(A) 100 mg
MM 0179.04 Imp. D (EP): 2-(4-Butoxyphenyl)acetamide O
NH2
O
(A) 100 mg
MM 0179.05 4'-Butoxyacetophenone
O
O (A) 100 mg
MM 0179.06 Ethyl 2-(4-Butoxyphenyl)acetate O
O
O
on request
Buflomedil Hydrochloride MM 0066.00 Buflomedil Hydrochloride
NOO
OOx HCl
(A) 500 mg
MM 0066.01 Imp. A (EP) as Hydrochloride: 4-(Pyrrolidin- 1-yl)-1-(2-hydroxy-4,6-dimethoxyphenyl)- butan-1-one Hydrochloride (o-Desmethyl-Buflomedil Hydrochloride)
NOOH
OOx HCl
(A) 100 mg
MM 0066.02 Imp. B (EP) as Hydrochloride: 4-(Pyrrolidin-1-yl)-1-(4-hydroxy-2,6-dimethoxyphenyl)butan-1-one Hydrochloride(p-Desmethyl-Buflomedil Hydrochloride)
NOO
OHOx HCl
(A) 100 mg
MM 0066.03 4-(1-Pyrrolidino)butyronitrile N
N (C) 100 mg
MM 0066.05 1,3,5-Trimethoxybenzene O
OO
(C) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 39
Code Product Code Unit
Bunolol Hydrochloride MM 0642.00 Bunolol Hydrochloride
OOH H
N x HClO
(A) 100 mg
Buphenine Hydrochloride MM 0710.00 Buphenine Hydrochloride
HO
OH
HNx HCl
(A) 500 mg
Bupivacaine Hydrochloride MM 0613.00 Bupivacaine Hydrochloride Monohydrate
HN
O
Nx HClx H2O
(A) 500 mg
MM 0368.03 Imp. A (EP): N-(2,6-Dimethylphenyl)pyridine- 2-carboxamide
HN
ON
(A) 100 mg
MM 0613.05 Imp. E (EP) as Hydrochloride: 6-(Butylamino)-N-(2,6-dimethylphenyl)hexanamide Hydrochloride
HN
O
NH
x HCl
(A) 50 mg
MM 0102.02 Imp. F (EP): 2,6-Dimethylaniline NH2
(B) 100 mg
MM 0613.07 Bupivacaine N-Oxide HN
ON
O
(A) 100 mg
Bupropion Hydrochloride MM 0745.00 Bupropion Hydrochloride
ClO
HN
x HCl
(A) 100 mg
MM 0745.02 2-(tert-Butylamino)-4'-chloropropiophenone Hydrochloride OHN
x HCl
Cl
(A) 100 mg
MM 0745.03 2-(tert-Butylamino)-3'-bromopropiophenone Hydrochloride OHN
x HClBr
on request
MM 0745.05 2-(tert-Butylamino)propiophenone Hydrochloride OHN
x HCl
(A) 100 mg
MM 0745.07 1-(3-Chlorophenyl)-1-hydroxy-2-propanone Cl
OH
O(D) 100 mg
MM 0745.08 3-Chloropropiophenone Cl
O (B) 100 mg
Buspirone Hydrochloride MM 0464.00 Buspirone Hydrochloride N
NNN
N
O
O
x HCl
(A) 500 mg
MM 0464.02 Imp. A (EP) as Dihydrochloride: 2-(Piperazin- 1-yl)pyrimidine Dihydrochloride
HN
N
N
N x 2 HCl
(A) 100 mg
New MM 0464.04 Imp. C (EP): 2,2'-[Butane- 1,4-diylbis(piperazine- 1,4-diyl)]dipyrimidine
N
NN
N
N
N
N
N
(A) 50 mg
Pharmaceutical impurities
40 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
New MM 0464.12 Imp. G (EP): 2,2'-(Piperazine-1,4-diyl)dipyrimidine
N
NN
N
N
N
(A) 50 mg
New MM 0464.14 Imp. I (EP): 8-[4-[4-(5-Chloropyrimidin-2- yl)-piperazin-1-yl]butyl]-8-azaspiro [4.5]decane-7,9-dione N
O
O
N
N
N
N
Cl
(A) 50 mg
MM 0464.08 Imp. K (EP): 8-Azaspiro[4,5]-decane-7,9-dione
NH
O
O
(B) 100 mg
New MM 0464.09 Imp. L (EP): 8-(4-Chlorobutyl)-8-azaspiro[4.5]- decane-7,9-dione
N
O
O
Cl
(A) 50 mg
New MM 0464.16 Imp. M (EP): 8-(4-Bromobutyl)-8-azaspiro[4.5]- decane-7,9-dione
N
O
O
Br
(A) 50 mg
Butalbital MM 0899.00 5,5-Diallybarbituric acid (Allobarbital)
[Controlled Substance] NH
HN OO
O
(A) 100 mg
Butenafine Hydrochloride MM 1041.00 Butenafine Hydrochloride
Nx HCl
on request
Butetamate Citrate MM 0606.00 Butetamate Citrate
O
O
N
x
OHO
OHO
OHO
OH
(A) 500 mg
Butyl Parahydroxybenzoate MM 0496.00 Butyl Parahydroxybenzoate
HO
O
O (A) 500 mg
MM 0045.01 Imp. A (EP): 4-Hydroxybenzoic Acid
HO
OH
O (B) 100 mg
MM 0431.00 Imp. B (EP): Methyl 4-Hydroxybenzoate (Methyl Parahydroxybenzoate)
HO
O
O (A) 500 mg
MM 0498.00 Imp. C (EP): Ethyl 4-Hydroxybenzoate (Ethyl Parahydroxybenzoate)
HO
O
O (A) 500 mg
MM 0432.00 Imp. D (EP): Propyl 4-Hydroxybenzoate (Propyl Parahydroxybenzoate)
HO
O
O (A) 500 mg
MM 0496.05 Imp. E (Pharmeuropa): 2-Methylpropyl 4- Hydroxybenzoate (Isobutyl Parahydroxybenzoate)
HO
O
O (A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 41
Code Product Code Unit
Butylhydroxytoluene MM 0679.00 Butylhydroxytoluene
OH
(A) 500 mg
Caffeine MM 0494.00 Caffeine
N
N N
N
O
O
(A) 500 mg
MM 0176.00 Imp. A (EP): Theophylline N
N N
HN
O
O (A) 500 mg
MM 0176.02 Imp. B (EP): N-(6-Amino-1,3-dimethyl-2,4-dioxo-1,2,3,4-tetrahydropyrimidin- 5-yl)formamide
N
NO
O
NH2
HN O
(A) 100 mg
MM 0494.03 Imp. C (EP): 1,3,9-Trimethyl-3,9-dihydro- 1H-purine-2,6-dione (Isocaffeine) N
N N
N
O
O
(A) 50 mg
MM 0577.00 Imp. D (EP): Theobromine HN
N N
N
O
O
(A) 500 mg
MM 0494.06 Imp. E (EP) as Nitrate: N,1-Dimethyl-4- (methylamino)-1H-imidazole-5-carbox- amide Nitrate (Caffeidine Nitrate)
NH
HN N
N
O
x HNO3
(A) 100 mg
MM 0494.04 Imp. F (EP): 1,7-Dimethyl-3,7-dihydro-1H-purine-2,6-dione (Paraxanthine;1,7-Dimethylxanthine) N
NNH
N
O
O
(D) 50 mg
Candesartan Cilexetil New MM 0776.01 Imp. A (Pharmeuropa): Ethyl 2-Ethoxy-1-[[2'-
(1H-tetrazol-5-yl)-4-biphenylyl]methyl]-1H-benzimidazole-7-carboxylate NH
NNN
N
NO
O
O(A) 100 mg
New MM 0776.07 Trityl Candesartan Cilexetil
NNN
NN
NO
O
OO
O
O(A) 100 mg
New MM 0776.08 Trityl Candesartan
NNN
NN
NO
O
OH(A) 100 mg
Capecitabine New MM 0992.02 2,3-O-Carbonyl-5-deoxy-5-fluoro-
N4-(pentyloxycarbonyl)cytidine
ON
N
O
HN OF
O
O O
O
(A) 100 mg
Pharmaceutical impurities
42 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Captopril MM 0067.00 Captopril
NHS
OO OH (A) 500 mg
MM 0067.01 Imp. A (EP): (2S,2'S)-1,1'-[Disulphanediyl-bis[(2S)-2-methyl-1-oxopropane-3,1-diyl]-bis[pyrrolidine-2-carboxylic] Acid (Captopril-Disulphide)
NS
OO OH
N S
OOHO
(A) 100 mg
MM 0067.02 Imp. C (Pharmeuropa): (2RS)-2-Methyl-3-sulphanylpropanoic Acid OHHS
O (A) 100 mg
MM 0067.06 Imp. D (Pharmeuropa): (2RS)-3-Bromo-2-methylpropanoic Acid O
OHBr
(A) 100 mg
MM 0067.08 Imp. E (Pharmeuropa): (2S)-1-[2-Methylpropanoyl]- pyrrolidine-2-carboxylic Acid
N
OO OH (A) 100 mg
MM 0067.05 Imp. J (Pharmeuropa) as Hydrate: 1-[(2S)-3-(Acetylthio)-2-methylpropanoyl]-L-proline Hydrate (S-Acetylcaptopril Hydrate)
NS
OO OH
Ox H2O
(A) 100 mg
MM 0067.04 Imp. K (Pharmeuropa): (2S)-3-(Acetylthio)-2-methylpropanoic Acid OHS
OO (C) 100 mg
MM 0067.15 Imp. N (Pharmeuropa): (2S,2'S)-3,3'-Disulphane-diylbis(2-methylpropanoic) Acid OHS
OSHO
O
(A) 50 mg
MM 0067.03 Captopril Ethyl Ester NHS
OO O on request
Carbamazepine MM 0076.00 Carbamazepine O
NH2N
(A) 250 mg
MM 0076.04 Imp. A (EP): 10,11-Dihydro-5H-dibenzo[b,f]-azepine-5-carboxamide (10,11-Dihydrocarbamazepine)
O
NH2N
(A) 100 mg
MM 0076.09 Imp. B (EP): 9-Methylacridine N
(A) 100 mg
MM 0076.12 Imp. C (EP): (5H-Dibenzo[b,f]azepin-5-yl-carbonyl)urea(N-Carbamoylcarbamazepine)
O
NH
N NH2
O (A) 100 mg
MM 0076.08 Imp. D (EP): 5H-Dibenzo[b,f]azepine (Iminostilbene)
NH
(B) 100 mg
MM 0076.06 Imp. E (EP): 10,11-Dihydro-5H-dibenzo[b,f]-azepine (Iminodibenzyl)
NH
(B) 100 mg
MM 0076.01 Carbamazepine 10,11-Epoxide O
NH2N
O
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 43
Code Product Code Unit
MM 0076.05 Imp. G (EP): 10-Bromo-5H-dibenzo[b,f]azepine- 5-carboxamide (10-Bromocarbamazepine)
O
NH2N
Br
(A) 100 mg
MM 0076.10 10-Hydroxy-10,11-dihydrocarbamazepine O
NH2N
HO
(A) 100 mg
MM 0076.17 Oxcarbazepine O
NH2N
O
(A) 100 mg
Carbasalate Calcium MM 0133.02 Imp. A (EP): 2-(Acetyloxy)benzoic Anhydride
(Acetylsalicylic Anhydride) O
O O O
O
O
O
(A) 100 mg
MM 0133.01 Imp. B (EP): 2-[[2-(Acetyloxy)benzoyl]oxy]benzoic Acid (Acetylsalicylsalicylic Acid)
O
OH
O
O
O
O
(A) 100 mg
MM 0045.00 Imp. C (EP): Salicylic Acid OH
O
OH
(A) 500 mg
MM 0133.03 Imp. D (EP): 2-[(2-Hydroxybenzoyl)oxy]- benzoic Acid (Salicylsalicylic Acid)
O
OH
O
O
OH
(A) 100 mg
Carbendazim MM 2500.00 Carbendazim
N
HN
NHO
O (A) 100 mg
MM 2500.01 2,3-Diaminophenazine N
N NH2
NH2
(A) 100 mg
MM 2500.02 2-Amino-3-hydroxyphenazine N
N NH2
OH
(A) 100 mg
Carbenicillin Sodium MM 0805.00 Carbenicillin Sodium
N
SH
O
NH
O
OONa
ONaO
(A) 250 mg
Carbocisteine MM 0236.00 Carbocisteine
S OHNH2
OHO
O
(A) 500 mg
MM 0236.01 (S)-Carboxymethyl-L-cysteine (R/S)-Sulphoxide S OH
NH2
OHO
O O
(A) 100 mg
MM 0236.02 Lactam of (S)-Carboxymethyl-L-cysteine
OH
O
NHS
O (A) 100 mg
Pharmaceutical impurities
44 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0236.03 L-Cysteinesulfinic Acid S OH
NH2
OHO
O
(C) 100 mg
Carisoprodol MM 0782.03 Imp. C (EP): 2-Methyl-2-propylpropane-1,3-diol HO OH (A) 100 mg
Carvedilol MM 0291.00 Carvedilol
O
O
HN
OH
O
HN
(A) 100 mg
MM 0291.02 Imp. B (EP): 1,1'-[[2-(2-Methoxyphenoxy) ethyl]nitrilo]bis[3-(9H-carbazol-4-yloxy) propan-2-ol]
O
ON
OH
O
HN
OHO NH
(A) 100 mg
MM 0291.03 Imp. C (EP): (2RS)-1-[Benzyl[2-(2-methoxy- phenoxy)ethyl]amino]-3-(9H-carbazol-4- yloxy)propan-2-ol
OO
N
OH
O
HN
(A) 100 mg
MM 0291.04 Imp. D (Pharmeuropa): Toluene (C) 100 mg
MM 0291.10 4-(2,3-Epoxypropoxy)carbazole O
HN
O (A) 100 mg
MM 0291.11 2-(2-Methoxyphenoxy)ethylamine Hydrochloride O
OH2N
x HCl
(A) 100 mg
Cefaclor MM 0326.00 Cefaclor Monohydrate
N
S
Cl
O OH
O
H
HN
O
NH2 x H2O
(A) 100 mg
MM 0253.12 Imp. A (EP): (2R)-2-Amino-2-phenylacetic Acid (D-Phenylglycine)
O
OHNH2 (B) 100 mg
MM 0253.08 Imp. F (EP): 3-Phenylpyrazin-2-ol
N
N OH (A) 100 mg
Cefadroxil Monohydrate MM 0232.09 Imp. A (EP): (2R)-2-Amino-2-(4-hydroxyphenyl)acetic Acid
HO
NH2
OH
O
(B) 100 mg
MM 0811.01 Imp. B (EP): (6R,7R)-7-Amino-3-methyl-8-oxo- 5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (7-ADCA; 7-Aminodesacetoxycephalosporanic Acid) N
S
O OH
O
H2N H
(A) 100 mg
Cefalexin Monohydrate MM 0605.00 Cefalexin Monohydrate
N
H
OHN
NH2
O
x H2O
S
O OH (A) 500 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 45
Code Product Code Unit
MM 0253.12 Imp. A (EP): (2R)-2-Amino-2-phenylacetic Acid (D-Phenylglycine)
O
OHNH2 (B) 100 mg
MM 0811.01 Imp. B (EP): (6R,7R)-7-Amino-3-methyl-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (7-Aminodesacetoxycephalosporanic Acid; 7-ADCA) N
S
O OH
O
H2N H
(A) 100 mg
Cefazolin Sodium MM 0238.00 Cefazolin Sodium
N
S
O ONa
OS
SNNH
HN
NN
NN O
(A) 100 mg
MM 0238.05 Imp. E (EP): 5-Methyl-1,3,4-thiadiazol-2-thiol (MMTD)
NNS
SH (A) 100 mg
MM 0238.08 Imp. H (EP): (6R,7R)-3-[(Acetyloxy)methyl]-7-amino-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (7-ACA)
N
S
O OH
OO
HH2N
O (A) 100 mg
Cefetamet MM 0811.01 7-Aminodesacetoxycephalosporanic Aicd
N
S
O OH
O
H2N H
(A) 100 mg
Cefoperazone Sodium MM 0853.03 Imp. C (EP): 1-Methyl-1H-tetrazole-5-thiol
N NNN
SH (A) 100 mg
MM 0238.08 Imp. E (EP): (6R,7R)-3-[(Acetyloxy)methyl]-7-amino-8-oxo-5-thia-1-azabicyclo- [4.2.0]oct-2-ene-2-carboxylic Acid (7-ACA) N
S
O OH
OO
HH2N
O (A) 100 mg
Cefradine MM 0811.01 Imp. A (EP): (6R,7R)-7-Amino-3-methyl-8-oxo-
5-thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylic Acid (7-Aminodeacetoxycephalosporanic Acid, 7-ADCA)
N
S
O OH
O
HH2N
(A) 100 mg
Celecoxib MM 0344.02 4-[5-[4-(Hydroxymethyl)phenyl]-3-(trifluoromethyl)-1H-pyrazol-
1-yl]-benzenesulfonamide N N
SH2N
O O
HO
F
FF
(D) 100 mg
MM 0344.03 4-[1-[4-(Aminosulfonyl)phenyl]-3-(trifluoromethyl)-1H-pyrazol-5-yl]benzoic Acid
N N
F
SH2N
O O
HO
O
FF
(D) 100 mg
Celiprolol Hydrochloride MM 0128.00 Celiprolol Hydrochloride O
NH
O
N
OOH
HN
x HCl
(A) 100 mg
Pharmaceutical impurities
46 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0128.01 Imp. A (EP): 1-[5-Amino-2-[(2RS)-3-[(1,1-dimethylethyl)amino]-2-hydroxypropoxy]phenyl]ethanone
O
H2N
O
OHHN
(A) 100 mg
MM 0128.03 Imp. C (EP): 1-[3-Acetyl-4-[(2RS)-3-[(1,1-dimethylethyl)amino]-2-hydroxypropoxy]phenyl]-3-(1,1-dimethylethyl)urea
O
NH
O
NH
O
OHHN
(A) 100 mg
MM 0128.10 Imp. D (EP):3-[3-Acetyl-4-[(RS)-3-(diethylamino)-2-hydroxypropoxy]phenyl]-1,1-diethylurea
O
NH
O
N
OOH
N
(D) 100 mg
MM 0128.05 Imp. E (EP): 1,1'-[[(1,1-Dimethylethyl)-imino]bis[(2-hydroxypropane-1,3-diyl)-oxy(3-acetyl-1,4-phenylene)]]bis(3,3-diethylurea)
O
HN
O
OH
N
O N
OH
O
O
NH
N O
(D) 50 mg
MM 0128.07 Imp. F (EP): 3-(3-Acetyl-4-hydroxyphenyl)-1,1-diethylurea O
NH
O
N
OH
(A) 100 mg
MM 0128.06 Imp. G (EP): 3-[3-Acetyl-4-[[(RS)-oxiranyl]methoxy]phenyl]-1,1-diethylurea
O
NH
O
N
OO
(A) 100 mg
MM 0128.04 Imp. H (EP): 3-[3-Acetyl-4-[(2RS)-3-bromo-2-hydroxypropoxy]phenyl]-1,1-diethylurea (Bromhydrin Compound)
O
NH
O
N
OOH
Br
(A) 100 mg
MM 0128.11 3-Acetyl-4-hydroxyaniline Hydrochloride O
H2N
OH x HCl
(A) 100 mg
MM 0128.58 5-Acetamido-2-hydroxyacetophenone O
NH
OOH
(A) 100 mg
Cethexonium Bromide MM 0501.01 rac-trans-2-Dimethylaminocyclohexanol Hydrochloride
OH
N
x HCl
and enantiomer
(A) 100 mg
Cetirizine Dihydrochloride MM 0380.00 Cetirizine Dihydrochloride
NN
OCl
x 2 HCl
OH
O (A) 100 mg
MM 0380.01 Imp. A (EP): (RS)-1-[(4-Chlorophenyl)phenylmethyl]piperazine N
NHCl (A) 100 mg
MM 0380.02 Imp. B (EP) as Dihydrochloride: (RS)-2-[4-[(4-Chlorophenyl)phenylmethyl]- piperazin-1-yl]acetic Acid Dihydrochloride
NN
OH
O
Cl
x 2 HCl
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 47
Code Product Code Unit
MM 0380.03 Imp. C (EP) as Dihydrochloride: (RS)-2-[2-[4-[(2-Chloro-phenyl)phenylmethyl]piperazin-1-yl]ethoxy]acetic Acid Dihydrochloride N
NO
OH
O
Cl x 2 HCl
(A) 100 mg
MM 0380.04 Imp. D (EP): 1,4-Bis[(4-chlorophenyl)- phenylmethyl]piperazine
N
NCl
Cl
(A) 100 mg
MM 0380.05 Imp. E (EP) as Dihydrochloride: (RS)- 2-[2-[2-[4-[(4-Chlorophenyl)phenyl- methyl]piperazin-1-yl]ethoxy]ethoxy]- acetic Acid Dihydrochloride (Ethoxycetirizine Dihydrochloride)
N
NOCl
OOH
O
x 2 HCl
(D) 100 mg
MM 0380.06 Imp. F (EP) as Dihydrochloride: [2-[4-[Diphenylmethyl]piperazin-1-yl]ethoxy]acetic Acid Dihydrochloride N
NO
OH
O
x 2 HCl
(A) 100 mg
MM 0380.11 Imp. G (EP) as Dihydrochloride: 2-[4-[(RS)-(4-Chlorophenyl)phenylmethyl]-piperazin-1-yl]ethanol Dihydrochloride
NN
OHCl
x 2 HCl
(A) 100 mg
MM 0380.08 Isopropyl Ester of Cetirizine
NN
OClO
O (A) 100 mg
MM 0380.09 4-Chlorobenzhydrol OH
Cl
(B) 100 mg
MM 0380.10 4-Chlorobenzophenone O
Cl
(B) 100 mg
MM 0380.13 Cetirizine N-Oxide
N
NO
OH
O
ClO (A) 100 mg
MM 0380.15 Ethyl Ester of Cetirizine Dihydrochloride
NN
OClO
O
x 2 HCl
(A) 100 mg
New MM 0380.16 Methyl Ester of Cetirizine Dihydrochloride
N
NO
O
OCl
x 2 HCl
(A) 100 mg
New MM 0380.17 3-Chlorocetirizine Dihydrochloride ((RS)-2-[2-[4-[(3-Chlorophenyl)phenyl-methyl]piperazin-1-yl]ethoxy]acetic AcidDihydrochloride) N
NO
OH
O
x 2 HCl
Cl
(A) 100 mg
Chlorambucil MM 0821.00 Chlorambucil OH
ON
Cl
Cl
(A) 500 mg
������������ ����������������������������������������
• Key references to FDA guidelines
• Designed specifically for preclinical drug discovery researchers
• Substrate and metabolites organised by metabolising enzyme
• Metabolite standards - labelled - unlabelled
• Enzyme inducers
• Enzyme transporter - substrates - inhibitors
• Model systems
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2580/CF/0410© LGC Limited 2010. All rights reserved.
NEW
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 49
Code Product Code Unit
Chloramphenicol MM 0516.00 Chloramphenicol NO2
NH
OHO
Cl
Cl OH
(A) 500 mg
MM 0516.01 (D)-(-)-threo-2-Amino-1-(4-nitrophenyl)-1,3-propanediol NO2
H2N
OH
OH
(A) 100 mg
Chlordiazepoxide Hydrochloride MM 0028.02 Imp. A (EP): 7-Chloro-5-phenyl-1,3-dihydro-
2H-1,4-benzodiazepin-2-one 4-Oxide (Demoxepam) N
HN
O
OCl
(A) 100 mg
MM 0028.04 Imp. B (EP): 6-Chloro-2-(chloromethyl)-4-phenylquinazoline 3-Oxide
Cl
N
NO
Cl (A) 100 mg
MM 0028.03 Imp. C (EP): (2-Amino-5-chlorophenyl)phenyl-methanone (Aminochlorobenzophenone)
Cl
NH2
O
(B) 100 mg
Chlorhexidine Diacetate MM 0162.00 Chlorhexidine Diacetate
HN
HN
HN
NH
NH
ClNH NH
NH
NH
NHCl
O
OHx 2
(A) 500 mg
MM 0162.05 4-Chloroaniline NH2
Cl
(B) 100 mg
MM 0162.07 (4-Chlorophenyl)urea HN NH2
ClO
(A) 100 mg
MM 0162.08 (4-Chlorophenyl)guanidine Hydrochloride HN NH2
ClNH
x HCl(C) 50 mg
Chlorhexidine Dihydrochloride MM 0946.00 Chlorhexidine Dihydrochloride
Cl
HN
HN
NH
HN
NH
NH
NH
NH
NH
NHCl
x 2 HCl
(A) 500 mg
Chlormezanone MM 0017.00 Chlormezanone
N
S
O
O OCl (A) 250 mg
MM 0017.02 2-(4-Chlorophenyl)-3-methylperhydro-1,3-thiazin-4-one
N
S
O
Cl on request
MM 0017.03 4-Chlorobenzaldehyde H
ClO (B) 100 mg
Chlorobutanol Hemihydrate MM 0535.00 Chlorobutanol Hemihydrate Cl
ClCl
OHx ½ H2O
(A) 500 mg
Pharmaceutical impurities
50 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Chlorocresol MM 0459.00 Chlorocresol OH
Cl
(A) 500 mg
Chlorphenamine Maleate MM 0090.00 Chlorphenamine Maleate
NN
O
OH
O
OHx
Cl (A) 500 mg
MM 0090.03 Imp. A (EP) as Dihydrochloride: 2-(4- Chlorophenyl)-4-(dimethylamino)-2- [2-(dimethylamino)ethyl]butanenitrile Dihydrochloride N N
N
Cl
x 2 HCl
(D) 100 mg
MM 0090.04 Imp. B (EP): N-(Pyridin-2-yl)pyridin-2-amine (2,2'-Dipyridylamine)
HNN
N
(A) 100 mg
MM 0090.13 Imp. C (EP) as Maleate: (3RS)-3-(4-Chloro- phenyl)-N-methyl-3-(pyridin-2-yl)propan-1- amine Maleate
NHN
O
OH
O
OHx
Cl (A) 100 mg
MM 0090.05 Imp. D (EP) as Maleate: (2RS)-2-(4-Chloro- phenyl)-4-(dimethylamino)-2-(pyridin-2- yl)butanenitrile Maleate
NN
N
ClO
OH
O
OHx
(D) 100 mg
MM 0090.11 Chlorphenamine N-Oxide Dihydrochloride
NN
Cl
O
x 2 HCl
(A) 100 mg
Chlorpromazine Hydrochloride MM 0420.00 Chlorpromazine Hydrochloride
NS
Cl
Nx HCl
(A) 500 mg
MM 0420.01 Imp. A (EP): 3-(2-Chloro-10H-phenothiazin-10-yl)-N,N-dimethylpropan-1-amine S-Oxide (Chlorpromazine Sulphoxide) N
S
Cl
N
O
(A) 100 mg
MM 0420.06 Imp. B (EP) as Dihydrochloride: N-[3-(2-Chloro-10H-phenothiazin-10-yl)propyl]-N,N',N'-trimethylpropane-1,2-diamine Dihydrochloride
NS
Cl
N N
x 2 HCl
(A) 100 mg
MM 0290.00 Imp. C (EP) as Hydrochloride: Promazine Hydrochloride N
S
Nx HCl
(A) 500 mg
MM 0420.07 Imp. D (EP) as Hydrochloride: 3-(2-Chloro-10H-phenothiazin-10-yl)-N-methylpropan-1-amine Hydrochloride (Desmethylchlorpromazine Hydrochloride)
NS
Cl
NHx HCl
(A) 100 mg
MM 0420.04 Imp. E (EP): 2-Chloro-10H-phenothiazine NH
S
Cl
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 51
Code Product Code Unit
MM 0420.02 Chlorpromazine Sulphoxide N-Oxide Maleate N
S
Cl
NO
O
O
OH
O
OHx
(B) 10 mg
Chlorprothixene Hydrochloride New MM 1321.01 Imp. A (EP): (RS)-2-Chloro-9-[3-(dimethylamino)-
propyl]-9H-thioxanthen-9-ol S
Cl
N
OH(A) 100 mg
New MM 1321.05 Imp. E (EP): 2-Chloro-9H-thioxanthen-9-one
S
Cl
O(A) 100 mg
Chlorquinaldol MM 0390.00 Chlorquinaldol OH
Cl
Cl
N(A) 500 mg
Chlortalidone MM 0297.00 Chlortalidone HNHO
O
Cl
SH2N
O O(A) 250 mg
Chlortetracycline Hydrochloride MM 0607.00 Chlortetracycline Hydrochloride OH O OH O
NH2
O
OH
OH
N
HH x HCl
Cl OH
(A) 500 mg
MM 0636.00 Imp. B (EP) as Hydrochloride: Demeclocycline Hydrochloride
OH O OH O
NH2
O
OH
OH
N
HH x HCl
Cl OH
(A) 250 mg
MM 0452.00 Tetracycline Hydrochloride OH O OH O
NH2
O
OH
OH
N
HH x HCl
HO
(A) 500 mg
Cholecalciferol MM 0249.02 Imp. B (EP): Cholesta-5,7-dien-3�-ol
(7,8-Didehydrocholesterol; Provitamin D3)
HO
(A) 100 mg
Ciclopirox Olamine MM 0418.00 Ciclopirox Olamine
N OOH
H2NOHx
(A) 250 mg
MM 0418.03 Imp. C (EP): 6-Cyclohexyl-4-methylpyridin-2(1H)-one HN O
(A) 50 mg
Cimetidine Hydrochloride MM 0020.00 Cimetidine
N
NH
NH
S
NHN
N (A) 500 mg
Pharmaceutical impurities
52 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0020.08 Imp. A (EP): 3-Cyano-2-methyl-1-[2- [[(5-methyl-1H-imidazol-4-yl)methyl]- sulphanyl]ethyl]isothiourea N
SNH
S
NHN
N (A) 100 mg
MM 0020.12 Imp. B (EP): 3-Cyano-2-methyl-1-[2-[[(5-methyl-1H-imidazol-4-yl)methyl]-sulphanyl]ethyl]isourea
N
ONH
S
NHN
N (A) 100 mg
MM 0020.03 Imp. C (EP) as Dihydrochloride: 1-[(Methylamino)[[2-[[(5-methyl-1H-imidazol-4-yl)-methyl]sulphanyl]ethyl]amino]- methylene]urea Dihydrochloride (Cimetidine Amide Dihydrochloride)
x 2 HClN
NH
NH
SN
HN
NH2O (A) 100 mg
MM 0020.06 Imp. D (EP) as Dihydrochloride:1-Methyl-3-[2-[[(5-methyl-1H-imidazol-4-yl)methyl]sulphanyl]ethyl]guanidine Dihydrochloride
x 2 HClNH
NH
NH
SN
HN (A) 100 mg
MM 0020.04 Imp. E (EP): 2-Cyano-1-methyl-3-[2-[[(5-methyl-1H-imidazol-4-yl)methyl]sulphinyl]ethyl]guanidine (Cimetidine Sulphoxide)
N
NH
NH
S
NHN
N
O
(A) 100 mg
MM 0020.15 Imp. G (EP): 2-Cyano-1,3-dimethylguanidine
NH
NH
N
N (A) 100 mg
MM 0020.07 Imp. H (EP): 1,1'-(Disulphanediyldiethylene)bis (2-cyano-3-methylguanidine)
N
HN
HN
SS
N
NH
NH
N
N (A) 100 mg
MM 0020.50 Imp. J (EP) as Dihydrobromide: 2-[[(5-Methyl-1H-imidazol-4-yl)methyl]-sulphanyl]ethanamine Dihydrobromide x 2 HBr
NH2S
NHN (A) 100 mg
MM 0020.10 1,1-Dimethyl-3-cyanoguanidine N
HN
NHN
(A) 100 mg
MM 0056.01 Cyanoguanidine H2NHN
NHN
(B) 100 mg
Cinchocaine Hydrochloride MM 0604.00 Cinchocaine Hydrochloride
x HClN
NH
ONO
(A) 500 mg
MM 0604.02 Imp. B (EP): 2-Hydroxyquinoline-4-carboxylic Acid
NOH
OHO
(A) 100 mg
MM 0604.05 Cinchocaine N-Oxide
N
NH
O
NOO
(A) 100 mg
Cinnarizine MM 1038.01 Imp. A (EP): 1-(Diphenylmethyl)piperazine
N
NH (A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 53
Code Product Code Unit
MM 1038.03 Imp. B (EP): (Z)-1-(Diphenylmethyl)-4-(3- phenylprop-2-enyl)piperazine
N
N
(A) 100 mg
MM 1038.04 Imp. C (EP): (4-(Diphenylmethyl)-1,1-bis[(E)- 3-phenylprop-2-enyl]piperazinium Chloride N
N+
Cl-
(A) 100 mg
MM 1038.06 Imp. E (EP): 1,4-Bis(diphenylmethyl)piperazine
N
N
(A) 100 mg
Ciprofloxacin Hydrochloride MM 0018.06 Ciprofloxacin Hydrochloride Monohydrate
NN
O
OH
O
HN
F
x HClx H2O
(A) 500 mg
MM 0018.01 Imp. A (EP): 7-Chloro-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid (Fluoroquinolonic Acid) NCl
O
OH
OF
(A) 100 mg
MM 0018.05 Imp. B (EP): 1-Cyclopropyl-4-oxo-7-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic Acid (Desfluoro Compound) NN
O
OH
O
HN (A) 100 mg
MM 0018.04 Imp. C (EP): 7-(2-Aminoethylamino)-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid (Ethylenediamine Compound)
NHN
O
OH
OF
H2N
(D) 50 mg
MM 0018.02 Imp. D (EP): 7-Chloro-1-cyclopropyl-4-oxo-6-(piperazin-1-yl)-1,4-dihydroquinoline-3-carboxylic Acid
NCl
O
OH
ON
HN
(D) 50 mg
MM 0018.03 Imp. E (EP): 1-Cyclopropyl-6-fluoro-7-(piperazin-1-yl)-quinolin-4(1H)-one (Decarboxylated Compound) NN
O
HN
F
(A) 100 mg
MM 0018.10 6-(2-Aminoethylamino)-7-chloro-1-cyclopropyl-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride NCl
O
OH
ONH
H2Nx HCl
(D) 100 mg
Citalopram Hydrobromide MM 0242.00 Citalopram Hydrobromide
ON
F
N
x HBr
(A) 250 mg
MM 0242.14 Imp. A (EP): (1RS)-1-[3-(Dimethylamino)- propyl]-1-(4-fluorophenyl)-1,3-dihydro- isobenzofuran-5-carboxamide (Citalopram- Amide)
ON
F
H2N
O
(A) 100 mg
Pharmaceutical impurities
54 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0242.17 Imp. C (EP): (3RS)-6-Cyano-3-[3-(dimethyl- amino)propyl]-3-(4-fluorophenyl)isobenzofuran-1(3H)-one
ON
F
N O
(A) 100 mg
MM 0242.09 Imp. D (EP) as Hydrochloride: (1RS)-1-(4- Fluorophenyl)-1-[3-(methylamino)propyl]-1,3- dihydroisobenzofuran-5-carbonitrile Hydro- chloride (Desmethylcitalopram Hydrochloride)
ONH
F
x HCl
N
(A) 100 mg
MM 0242.12 Imp. E (EP) as Oxalate: 3-[(1RS)-5-Chloro-1-(4-fluorophenyl)-1,3-dihydroisobenzofuran-1-yl]-N,N-dimethylpropan-1-amine Oxalate
ON
F
Cl
HO O
OHO
x
(A) 50 mg
Citric Acid Anhydrous MM 0988.00 Citric Acid Anhydrous
O
HO OH
OHOO OH (A) 250 mg
Citric Acid Monohydrate MM 0575.00 Citric Acid Monohydrate
x H2OO
HO OH
OHOO OH (A) 500 mg
Clarithromycin MM 0057.00 Clarithromycin
O
O
O
O
O
OH
OHOO
NHO
O
O
OH
on request
MM 0057.05 Imp. E (EP): 6,11-Di-O-methylerythromycin A O
O
OOH
O
O
O
O
O
OH
OO
N
OH
(D) 100 mg
Clindamycin Hydrochloride New MM 0259.00 Clindamycin Hydrochloride
O
OH
HO
HN
OH
S
Cl
O
N
x HCl
(A) 100 mg
Clioquinol MM 0312.00 Clioquinol
N
Cl
OHI
(A) 500 mg
MM 0312.01 Imp. A (EP): 5-Chloroquinolin-8-ol N
Cl
OH (B) 100 mg
MM 0312.02 Imp. B (EP): 5,7-Dichloroquinolin-8-ol N
Cl
OHCl
(B) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 55
Code Product Code Unit
MM 0312.03 Imp. C (EP): 5,7-Diiodoquinolin-8-ol N
I
OHI
(B) 100 mg
Clobenzorex Hydrochloride MM 0649.00 Clobenzorex Hydrochloride H
N
Cl
x HCl
(A) 500 mg
Clobetasol Propionate MM 0769.00 Clobetasol Propionate
HO
F
O
OOCl
O
(A) 100 mg
MM 0200.01 Imp. G (EP): 21-Chloro-9-fluoro-11�,17-dihydroxy-16�-methylpregna-1,4-diene-3,20-dione (Clobetasol)
HO
F
OH
OCl
O
(A) 100 mg
MM 0202.04 Imp. K (EP):9-Fluoro-11�,17-dihydroxy- 16�-methyl-3,20-dioxopregna-1,4-dien- 21-yl Propanoate (Betamethasone 21- Propionate) HO
F
OH
OO
O
O (A) 100 mg
Clobutinol Hydrochloride MM 0038.00 Clobutinol Hydrochloride
N
ClOH
x HCl
on request
MM 0038.01 1-Dimethylamino-2-methylbutan-3-one N
O
(A) 100 mg
Clomifene Citrate MM 0650.00 Clomifene Citrate
Cl
ON
OHO
OHO
OHO
OH
x
and Z-Isomer
(A) 250 mg
MM 0650.01 Clomifene N-Oxide Hydrochloride
Cl
ON
and Z-Isomer
O
x HCl
(A) 100 mg
MM 0650.03 Desethylclomifene Hydrochloride
Cl
ONH
and Z-Isomerx HCl
(A) 100 mg
Clomipramine Hydrochloride MM 0545.00 Clomipramine Hydrochloride
N x HClN
Cl (A) 500 mg
Pharmaceutical impurities
56 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0545.01 Imp. A (EP) as Dihydrochloride: N-[3-(3- Chloro-10,11-dihydro-5H-dibenzo[b,f]azepin- 5-yl)propyl]-N,N',N'-trimethylpropane-1,3- diamine Dihydrochloride N
x 2 HCl
N
Cl
N
on request
MM 0077.00 Imp. B (EP) as Hydrochloride: Imipramine Hydrochloride
N x HClN
(A) 500 mg
MM 0545.03 Imp. C (EP) as Hydrochloride: 3-(3-Chloro-5H-dibenzo[b,f]azepin-5-yl)-N,N-dimethylpropan-1-amine Hydrochloride
N x HClN
Cl (C) 10 mg
MM 0545.04 Imp. D (EP) as Hydrochloride: 3-(3,7-Dichloro- 10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)-N,N- dimethylpropan-1-amine Hydrochloride
N x HClN
Cl
Cl
(A) 10 mg
MM 0076.06 Imp. E (EP): 10,11-Dihydro-5H-dibenzo[b,f]-azepine (Iminodibenzyl)
NH
(B) 100 mg
MM 0545.06 Imp. F (EP): 3-Chloro-10,11-dihydro-5H-dibenzo[b,f]azepine
NH
Cl (A) 100 mg
MM 0545.07 Imp. G (EP): 3-Chloro-5-(prop-2-enyl)-10,11-dihydro-5H-dibenzo[b,f]azepine
N
Cl (C) 50 mg
MM 0545.08 Desmethylclomipramine Hydrochloride
NH
x HClN
Cl (A) 100 mg
MM 0545.09 Clomipramine N-Oxide
NN
Cl
O
on request
MM 0545.13 3-Chloro-10-[3(dimethylamino)propyl]-9-acridanone
NN
O
Cl (A) 100 mg
Clonazepam New MM 0945.01 Imp. A (EP): (2-Amino-5-nitrophenyl)(2-
chlorophenyl)methanone O2N
O
Cl
NH2 (A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 57
Code Product Code Unit
New MM 0945.02 Imp. B (EP): 3-Amino-4-(2-chlorophenyl)-6-nitroquinolin-2(1H)-one HN O
NH2O2N
Cl
(A) 50 mg
New MM 0945.04 Methylclonazepam
O2N N
NO
Cl
(A) 50 mg
New MM 0945.05 2-Bromo-2'-(2-chlorobenzoyl)-4'-nitroacetanilide
O2NO
Cl
NH
OBr (A) 50 mg
MM 0945.01 Imp. A (EP): (2-Amino-5-nitrophenyl)(2- chlorophenyl)methanone
O2NO
Cl
NH2 (A) 100 mg
Clonidine Hydrochloride MM 0983.00 Clonidine Hydrochloride
NCl
Cl
NH
HNx HCl
(A) 100 mg
MM 0983.04 Imp. A (EP): 1-Acetylimidazolidin-2-one O N
HN
O
(A) 100 mg
New MM 0983.03 Imp. B (EP): 1-Acetyl-2-[(2,6-dichloro- phenyl)amino]-4,5-dihydro-1H-imidazole
NH
Cl
Cl
N
N
O
(A) 50 mg
MM 0006.21 Imp. C (EP): 2,6-Dichloroaniline NH2
Cl
Cl (B) 100 mg
MM 0983.02 1-(2,6-Dichlorophenyl)thiourea
Cl
Cl
NH
NH2
S (A) 100 mg
Clopidogrel Hydrogen Sulphate MM 0455.10 Clopidogrel Hydrogen Sulphate
Cl
N
O O
S
x H2SO4
(A) 100 mg
MM 0455.09 Clopidogrel Alcohol
Cl
N
OH
S
(D) 100 mg
MM 0455.13 Imp. B (Pharmeuropa) as Racemate Hydrogen Sulphate: Methyl (2RS)-(2-Chlorophenyl)[4,7- dihydrothieno[2,3-c]pyridin-6(5H)-yl]ethanoate Hydrogen Sulphate Cl
N
O O
S x H2SO4
(A) 100 mg
MM 0455.12 Imp. C (Pharmeuropa) as Hydrogen Sulphate: Methyl (2R)-(2-Chlorophenyl)[6,7-dihydrothieno [3,2-c]pyridin-5(4H)-yl]ethanoate Hydrogen Sulphate ((R)-Clopidogrel Hydrogen Sulphate) Cl
N
O O
S
x H2SO4
(A) 100 mg
Clotrimazole MM 0015.00 Clotrimazole
N
N
Cl (A) 500 mg
Pharmaceutical impurities
58 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0015.01 Imp. A (EP): (2-Chlorophenyl)diphenylmethanol
OHCl
(A) 100 mg
MM 0015.10 Imp. B (EP): 1-[(4-Chlorophenyl)diphenylmethyl]-1H-imidazole
N
N
Cl (A) 100 mg
MM 0015.03 Imp. C (EP): 1-Chloro-2-(chlorodiphenylmethyl)benzene
ClCl
(A) 100 mg
MM 0015.02 Imp. D (EP): Imidazole
N
HN (B) 100 mg
MM 0015.06 Imp. E (EP): (2-Chlorophenyl)phenylmethanone (2-Chlorobenzophenone)
Cl O
(A) 100 mg
MM 0015.11 Imp. F (EP): 1-(Triphenylmethyl)-1H-imidazole (Deschloroclotrimazole)
N
N
(A) 100 mg
MM 0015.04 (2-Chlorophenyl)diphenylmethane
Cl
(A) 100 mg
MM 0015.05 (2-Chlorophenyl)diphenylmethyl Ethyl Ether
OCl
(A) 100 mg
MM 0015.07 (2-Chlorophenyl)phenyldichloromethane
Cl Cl Cl
(A) 100 mg
MM 0015.08 (2-Chlorophenyl)trichlormethane Cl
Cl ClCl
(A) 100 mg
MM 0015.09 1-[(2-Chlorophenyl)diphenylmethyl]-1H-pyrazole
NNCl
(C) 50 mg
Cloxacillin Sodium MM 0682.00 Cloxacillin Sodium Monohydrate
NO
S
OONa
H
x H2OHN
O
NO
Cl (A) 500 mg
MM 0026.04 Imp. C (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid (6-Aminopenicillanic Acid) N
O
S
OOH
HH2N
(B) 100 mg
MM 0682.04 Imp. D (EP): 3-(2-Chlorophenyl)-5-methylisoxazole-4-carboxylic Acid N
O
Cl
OH
O
(A) 100 mg
Cloxiquine MM 0391.00 Cloxiquine OH
Cl
N(A) 500 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 59
Code Product Code Unit
Clozapine MM 0480.00 Clozapine
NN
N
HN
Cl (A) 100 mg
MM 0480.01 Imp. A (EP): 8-Chloro-5,10-dihydro-11H-dibenzo[b,e][1,4]diazepin-11-one O
HN
HN
Cl (A) 100 mg
MM 0480.03 Imp. C (EP): 8-Chloro-11-(piperazin-1-yl)-5H-dibenzo[b,e][1,4]diazepine N
NHN
HN
Cl (A) 100 mg
Codeine MM 0442.00 Codeine Phosphate Hemihydrate
[Controlled Substance]
O OHO
N
x ½ H2Ox H3PO4
(A) 100 mg
MM 0004.00 Codeine Monohydrate [Controlled Substance]
O OHO
N
x H2O
(A) 100 mg
MM 0004.03 Imp. A (EP): 7,8-Didehydro-4,5�-epoxy-3,6�-dimethoxy- 17-methylmorphinan (O-Methylcodeine) [Controlled Substance]
O OO
N (A) 100 mg
MM 0037.00 Imp. B (EP) as Hydrochloride Trihydrate: Morphine Hydrochloride Trihydrate [Controlled Substance]
O OHHO
N
x HClx 3 H2O
(A) 250 mg
MM 0280.00 Imp. B (EP) as Hemisulphate Pentahemihydrate: Morphine Hemisulphate Pentahemihydrate [Controlled Substance]
O OHHO
N
x H2SO4x 5 H2O
2
(A) 250 mg
MM 0037.02 Imp. C (EP): 7,7',8,8'-Tetradehydro-4,5�:4',5'�-diepoxy-3,3'-dimethoxy-17,17'-dimethyl-2,2'-bimorphinanyl-6�,6'�-diol (Codeine Dimer; Dimethyl Pseudomorphine)
O OHO
NOHO O
N
(A) 100 mg
MM 0004.01 Codeine N-Oxide [Controlled Substance]
O OHO
NO (A) 250 mg
MM 0004.02 Codeinone
O OO
N (A) 100 mg
MM 0004.04 Codeimethine
O OHO
N (C) 50 mg
MM 0004.05 Norcodeine [Controlled Substance]
O OHO
HN (A) 100 mg
MM 0004.06 Acetylcodeine [Controlled Substance]
O OO
N
O
(A) 100 mg
Pharmaceutical impurities
60 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0004.08 Isocodeine [Controlled Substance]
O OHO
N (A) 100 mg
MM 0037.01 Pseudomorphine
O OHHO
NOHO OH
N
(A) 100 mg
Colchicine MM 1083.00 Colchicine O
O
OO
O
NH
O
(A) 100 mg
MM 1083.04 Imp. D (EP): N-[(7S,12aS)-3-(�-D-Glucopyranosyloxy)-1,2,10-trimethoxy-9-oxo-5,6,7,9-tetrahydrobenzo[a]heptalen-7-yl]acetamide (Colchicoside)
O
O
NH
O
O
O
O
HO
HO
OH
OH O
(A) 100 mg
Cortisone MM 0214.00 Cortisone
O
O OH
OOH
(A) 500 mg
Cortisone Acetate MM 0186.00 Cortisone Acetate
O
O OH
OO
O (A) 500 mg
MM 0187.00 Imp. A (EP): Hydrocortisone Acetate
O
HO OH
OO
O (A) 500 mg
Cyclizine Hydrochloride New MM 1265.01 Imp. A (EP): 1-Methylpiperazine
HN
N (A) 100 mg
MM 0490.02 Imp. B (EP): Diphenylmethanol (Benzhydrol) OH
(B) 100 mg
Cyclobenzaprine Hydrochloride MM 0062.02 Cyclobenzaprine Hydrochloride
N x HCl
(A) 100 mg
Cyclopentolate Hydrochloride MM 0580.00 Cyclopentolate Hydrochloride O
ON
x HClHO
(A) 500 mg
MM 0580.01 Imp. A (EP): (2RS)-(1-Hydroxycyclopentyl)(phenyl)acetic Acid O
OHHO
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 61
Code Product Code Unit
MM 0160.03 Imp. B (EP): Phenylacetic Acid [Drug Precursor] O
OH
(B) 100 mg
MM 0580.03 Imp. C (EP) as Hydrochloride: 2-(Dimethylamino)ethyl Phenylacetate Hydrochloride
O
ON
x HCl(A) 100 mg
Cynarine MM 0048.01 3,4-Dihydroxycinnamic Acid (Caffeic Acid)
OH
OHO
HO
(B) 100 mg
Cyproheptadine Hydrochloride MM 0609.00 Cyproheptadine Hydrochloride Sesquihydrate N
x HCl x 11/2 H2O
(A) 500 mg
New MM 0609.01 Imp. A (EP): 5H-Dibenzo[a,d][7]annulene (Dibenzocycloheptene)
(A) 50 mg
MM 0062.01 Imp. B (EP): 10,11-Dihydro-5H-dibenzo[a,d][7]- annulen-5-one (Dibenzosuberone) O
(B) 100 mg
New MM 0609.07 Imp. C (EP) as Hydrochloride: 5-(1-Methyl- piperidin-4-yl)-5H-dibenzo[a,d][7]annulen-5- ol Hydrochloride
OHN
x HCl
(A) 50 mg
MM 0609.02 5H-Dibenzo[a,d]cyclohepten-5-one (Dibenzosuberenone) O
(C) 100 mg
MM 0609.04 Demethylcyproheptadine Hydrochloride NH
x HCl
(A) 100 mg
MM 0609.05 Cyproheptadine �-N-Oxide N
O (A) 100 mg
MM 0609.06 Cyproheptadine �-N-Oxide N
O (A) 100 mg
Cyproterone Acetate MM 0215.00 Cyproterone Acetate
O
O
O
Cl
O
(A) 250 mg
Dacarbazine New MM 1289.02 Imp. B (EP): 5-Amino-1H-imidazole-4-carboxamide
O
NH2
NHN
H2N
(A) 100 mg
MM 0056.06 Imp. D (EP) as Hydrochloride: N-Methylmethanamine Hydrochloride
HN x HCl (C) 100 mg
Pharmaceutical impurities
62 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
DDT MM 2513.01 2,2-Bis(4-chlorophenyl)-1-chloroethane
Cl
Cl
Cl
(A) 100 mg
MM 2513.02 1-Chloro-3-[1-(4-chlorophenyl)ethyl]benzene
Cl
Cl(A) 100 mg
MM 2513.05 1,1-Bis(4-chlorophenyl)ethane
Cl Cl
(A) 100 mg
Dembrexine Hydrochloride Monohydrate New MM 1200.03 Imp. C (EP): 3,5-Dibromo-2-hydroxybenzaldehyde
Br Br
OH
O (A) 100 mg
MM 1200.04 Imp. D (EP): 2-Hydroxybenzaldehyde (Salicylaldehyde) OH
O (A) 100 mg
New MM 1200.05 Imp. E (EP): 2,4,6-Tribromophenol
Br Br
OH
Br (A) 100 mg
Demeclocycline Hydrochloride MM 0636.00 Demeclocycline Hydrochloride OH O OH O
NH2
O
OH
OH
N
HH x HCl
Cl OH
(A) 250 mg
Desipramine Hydrochloride MM 0589.00 Desipramine Hydrochloride
NH
x HClN
(A) 250 mg
MM 0077.00 Imipramine Hydrochloride
N x HClN
(A) 500 mg
MM 0076.06 Iminodibenzyl
NH
(B) 100 mg
Dexamethasone MM 0213.00 Dexamethasone
O
HO
F
OH
O
OH(A) 250 mg
MM 0200.00 Imp. B (EP): Betamethasone
O
HO
F
OH
O
OH(A) 250 mg
MM 0213.01 Imp. C (EP): 9-�-Fluoro-11�,17�,21- trihydroxy-16�-methylpregn-4-ene-3,20-dione
O
HO
F
OH
O
OH(D) 50 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 63
Code Product Code Unit
MM 0445.00 Imp. G (EP): Dexamethasone Acetate
O
HO
F
OH
O
O
O (A) 250 mg
Dexamethasone Acetate MM 0445.00 Dexamethasone Acetate
O
HO
F
OH
O
O
O (A) 250 mg
MM 0213.00 Imp. A (EP): 9-Fluoro-11�,17,21-trihydroxy- 16�-methylpregna-1,4-diene-3,20-dione (Dexamethasone)
O
HO
F
OH
O
OH(A) 250 mg
MM 0201.00 Imp. D (EP): 9-Fluoro-11�,17-dihydroxy-16�-methyl-3,20-dioxopregna-1,4-dien-21-yl Acetate (Betamethasone Acetate)
O
HO
F
OH
O
O
O (A) 250 mg
Dexamethasone Sodium Phosphate MM 0210.00 Dexamethasone Sodium Phosphate
O
HO
F
OH
O
O PONa
OONa (A) 250 mg
MM 0213.00 Imp. A (EP): Dexamethasone
O
HO
F
OH
O
OH(A) 250 mg
MM 0303.00 Imp. B (EP): Betamethasone Sodium Phosphate
O
HO
F
OH
O
O PONa
OONa on request
Dexchlorpheniramine Maleate MM 1114.00 Dexchlorpheniramine Maleate
NN
Cl
OH
O
O
OHx
(A) 100 mg
MM 0059.00 Imp. A (EP) as Maleate: (3RS)-N,N-Dimethyl-3- phenyl-3-(pyridin-2-yl)propan-1-amine Maleate (Pheniramine Maleate) N
N
OH
O
O
OHx
(A) 100 mg
Dextromethorphan Hydrobromide MM 0033.00 Dextromethorphan Hydrobromide Monohydrate
O
N
x HBrx H2O
(A) 500 mg
MM 0033.10 Imp. A (EP) as Hydrochloride: ent-3-Methoxymorphinan Hydrochloride
O
HN
x HCl
(A) 100 mg
Pharmaceutical impurities
64 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0033.09 Imp. B (EP) as (L)-Tartrate: ent-17-Methylmorphinan-3-ol (L)-Tartrate
HO
N
HOOH
OHOH
O
O
x
(A) 100 mg
MM 0033.02 Imp. C (EP): ent-3-Methoxy-17-methylmorphinan-10-one
O
NO (D) 100 mg
MM 0033.11 Dextromethorphan N-Oxide Hydrochloride
O
N
x HCl
O (A) 100 mg
Dextropropoxyphene Hydrochloride MM 0098.01 Dextropropoxyphene Hydrochloride
[Controlled Substance] O
O
N
x HCl
(A) 50 mg
MM 0098.00 Dextropropoxyphene [Controlled Substance] O
O
N (A) 50 mg
MM 0098.06 Imp. A (EP): (2S,3R)-4-(Dimethylamino)-1,2-diphenyl-3-methylbutan-2-ol
OH
N (A) 100 mg
MM 0098.07 Imp. B (EP) as Hydrochloride: (1S,2R)-1- Benzyl-3-(dimethylamino)-2-methyl-1- phenylpropyl Acetate Hydrochloride (Acetoxyphene Hydrochloride)
O
O
N
x HCl
(A) 100 mg
MM 0098.08 Imp. C: (EP) as Hydrochloride: (1S,2R)-1- Benzyl-3-(dimethylamino)-2-methyl-1-phenyl- propyl Butanoate Hydrochloride (Butyroxy- phene Hydrochloride)
O
O
N
x HCl
(A) 50 mg
MM 0291.04 Toluene (C) 100 mg
Diazepam MM 0023.00 Diazepam
[Controlled Substance]N
NO
Cl
(A) 100 mg
MM 0023.02 Imp. A (EP): 7-Chloro-5-phenyl-1,3-dihydro-2H- 1,4-benzodiazepin-2-one (Nordazepam) [Controlled Substance] N
HN
O
Cl
(A) 100 mg
MM 0023.04 Imp. B (EP): 2-Chloro-N-(4-chloro-2-benzoylphenyl)-N-methylacetamide
Cl
N
O
OCl (A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 65
Code Product Code Unit
MM 0023.03 Imp. C (EP): 3-Amino-6-chloro-1-methyl-4-phenylquinolin-2(1H)-one
Cl
N
NH2
O(A) 100 mg
MM 0023.01 Imp. D (EP): [5-Chloro-2-(methylamino)phenyl]phenylmethanone (5-Chloro-2-(methylamino)benzophenone)
Cl
NH
O
(B) 100 mg
MM 0023.05 2'-Benzoyl-2,4'-dichloroacetanilide
Cl
NH
O
OCl (A) 100 mg
Dibutyl Sebacate MM 0925.00 Dibutyl Sebacate OO
O O
(A) 500 mg
Dichlorobenzyl Alcohol MM 0739.01 Bis-(2,4-dichlorobenzyl)Ether
ClCl
O
ClCl
(A) 100 mg
Diclofenac Sodium MM 0006.00 Diclofenac Sodium
NH
O ONa
ClCl
(A) 500 mg
MM 0006.01 Imp. A (EP): 1-(2,6-Dichlorophenyl)-1,3-dihydro-2H-indol-2-one
ClClN
O(A) 100 mg
MM 0006.03 Imp. B (EP): 2-[(2,6-Dichlorophenyl)amino]benzaldehyde NH
ClCl
O (A) 100 mg
MM 0006.04 Imp. C (EP): [2-[(2,6-Dichlorophenyl)amino]phenyl]methanol NH
ClCl
OH (A) 100 mg
MM 0006.09 Imp. D (EP): 2-[2-[(2-Bromo-6-chlorophenyl)amino]phenyl]acetic Acid
NH
ClBr
OH
O
(D) 100 mg
MM 0006.05 Imp. D (EP) as Sodium Salt: Sodium 2-[2-[(2-Bromo- 6-chlorophenyl)amino]phenyl]acetate
NH
ClBr
ONa
O
(D) 100 mg
MM 0006.02 Imp. E (EP): 1,3-Dihydro-2H-indol-2-one NH
O(B) 100 mg
MM 0006.06 1-(2-Bromo-6-chlorophenyl)indolin-2-one
ClBrN
O(C) 10 mg
Pharmaceutical impurities
66 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0006.10 Methyl 2-[2-[(2,6-Dichlorophenyl)amino]phenyl]acetate (Methyl Ester of Diclofenac) NH
ClCl
O
O
(A) 100 mg
MM 0006.11 Ethyl [2-[(2,6-Dichlorophenyl)amino]phenyl]acetate (Ethyl Ester of Diclofenac) NH
ClCl
O
O
(A) 100 mg
MM 0181.06 Isopropyl 2-[2-[(2,6-Dichlorophenyl)amino]phenyl]acetate (Isopropyl Ester of Diclofenac) NH
ClCl
O
O
(A) 100 mg
MM 0006.12 2-(2,6-Dichlorophenylamino)benzoic Acid
NHClCl
OH
O (A) 100 mg
MM 0006.15 2,6-Dichlorodiphenylamine NH
ClCl
(A) 100 mg
MM 0006.16 2-Bromo-6-chlorodiphenylamine NH
ClBr
(A) 100 mg
MM 0006.17 1-(2,6-Dichlorophenyl)indolin-2,3-dione
ClClN
O
O (A) 100 mg
MM 0006.18 Diclofenac Potassium NH
ClCl
OK
O
(A) 100 mg
MM 0006.19 2-Chloro-N-(2,6-dichlorophenyl)-N-phenylacetamide
N
ClCl
O
Cl (A) 100 mg
MM 0006.20 2-[2-[(2,6-Dichlorophenyl)amino]phenyl]acetic Acid (Diclofenac)NH
ClCl
OH
O
(A) 100 mg
MM 0006.21 2,6-Dichloroaniline NH2ClCl
(B) 100 mg
MM 0006.22 2-Bromo-6-chloroaniline NH2ClBr
on request
MM 0006.27 N-Acetyl-N-phenyl-2,6-dichloroaniline N
ClCl
O (A) 100 mg
MM 0006.28 Diethyl Phthalate O
O
O
O
(C) 100 mg
Dicloxacillin Sodium MM 0229.00 Dicloxacillin Sodium Monohydrate
N
SH
O
OONa
x H2OHN
O
NO
Cl
Cl on request
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 67
Code Product Code Unit
MM 0026.04 Imp. C (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid (6-Aminopenicillanic Acid)
N
SH
O
H2N
OOH (B) 100 mg
Diflucortolone Valerate MM 0600.00 Diflucortolone Valerate
OF
F
HO
OO
O (A) 100 mg
Digitoxin MM 0336.01 Digitoxigenin
HOOH
O O (A) 50 mg
Digoxin MM 0212.00 Digoxin
O
OH
O O
HO
OHOO
OOOH
HO
OH
OH
(A) 250 mg
Dihydrocodeine Hydrogen Tartrate New MM 0280.00 Imp. B (EP) as Hemisulphate Pentahemihydrate:
Morphine Hemisulphate Pentahemihydrate [Controlled Substance]
O OHHO
N
2
x H2SO4x 5 H2O
(A) 250 mg
New MM 0037.00 Imp. B (EP) as Hydrochloride Trihydrate: Morphine Hydrochloride Trihydrate [Controlled Substance]
O OHHO
N
x HClx 3 H2O
(A) 250 mg
New MM 0004.00 Imp. A (EP) as Monohydrate: Codeine Monohydrate [Controlled Substance]
O OHO
N
x H2O
(A) 100 mg
New MM 0442.00 Imp. A (EP) as Phosphate Hemihydrate: Codeine Phosphate Hemihydrate [Controlled Substance]
O OHO
N
x H3PO4x 1/2 H2O
(A) 100 mg
Diltiazem Hydrochloride MM 0068.00 Diltiazem Hydrochloride
N
SO
O
N
O
O
x HCl
(A) 500 mg
MM 0068.02 Imp. B (EP): (2S,3S)-2-(4-Methoxyphenyl)-4-oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin-3-yl Acetate
NH
SO
OO
O (A) 100 mg
Pharmaceutical impurities
68 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0068.03 Imp. D (EP) as Hydrochloride: (2S,3S)-2-(4-Methoxyphenyl(-5-[2-(methylamino)ethyl]-4-oxo-2,3,4,5-tetrahydro-1,5-benzothiazepin-3-yl Acetate Hydrochloride (N-Desmethyldiltiazem Hydrochloride)
N
SO
O
HN
O
O
x HCl
(A) 100 mg
MM 0068.04 Imp. E (EP):(2S,3S)-3-Hydroxy-2-(4-methoxyphenyl)-2,3-dihydro-1,5-benzothiazepin-4(5H)-one
NH
SOH
O
O (A) 100 mg
MM 0068.05 Imp. F (EP):(2S,3S)-5-[2-(Dimethylamino)ethyl]-3-hydroxy-2-(4-methoxyphenyl)-2,3-dihydro-1,5- benzothiazepin-4(5H)-one
N
SOH
N
O
O (A) 100 mg
MM 0068.07 Diltiazem Sulphoxide
N
SO
O
N
O
O
O
(A) 100 mg
MM 0068.08 Diltiazem Maleate
N
SO
O
N
O
O
O
OH
O
OHx
(A) 100 mg
Dimenhydrinate MM 0599.00 Dimenhydrinate
ON N
N N
HN
Cl
O
O
x
(A) 500 mg
MM 0176.00 Imp. A (EP): Theophylline N
N N
HN
O
O (A) 500 mg
MM 0599.04 Imp. B (EP): 8-[(2-(Diphenylmethoxy)- ethyl)(methlyl)amino]-1,3-dimethyl-3,7-dihydro- 1H-purine-2,6-dione
N
N
O
O N
HN
N
O
(A) 100 mg
MM 0494.00 Imp. C (EP): Caffeine N
N N
N
O
O
(A) 500 mg
MM 0490.03 Imp. F (EP) as Hydrochloride: 2-(Diphenylmethoxy)-N-methylethanamine Hydrochloride (Diphenhydramine Imp. A Hydrochloride; Nordiphenhydramine Hydrochloride) O
HN
x HCl
(A) 100 mg
MM 0490.04 Imp. G (EP) as Hydrochloride: N,N-Dimethyl-2-[(4-methylphenyl)- (phenyl)methoxy]ethanamine Hydrochloride (4-Methyldiphenhydramine Hydrochloride)
ON
x HCl
(A) 100 mg
MM 0640.00 Imp. H (EP) as Hydrochloride: 2-[(RS)-(4- Bromophenyl)(phenyl)methoxy]-N,N-dimethyl- ethanamine Hydrochloride (4-Bromodiphen- hydramine Hydrochloride; Bromazine Hydro- chloride)
ON
x HCl
Br
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 69
Code Product Code Unit
MM 0490.02 Imp. I (EP): Diphenylmethanol (Benzhydrol)
OH
(B) 100 mg
MM 0630.01 Imp. J (EP): Diphenylmethanone (Benzophenone)
O
(B) 100 mg
New MM 0599.14 Imp. K (EP): [Oxybis(methanetriyl)]tetrabenzene (Bis(diphenylmethyl) Ether)
O
(A) 50 mg
MM 0490.00 Diphenhydramine Hydrochloride
ON
x HCl
(A) 500 mg
MM 0155.02 8-Chlorotheophylline N
N N
HN
Cl
O
O
(B) 100 mg
MM 0599.03 8-[N-(2-Diphenylmethoxyethyl)-N,N- dimethylaminium]-1,3-dimethylxanthine inner salt
N
N
O
O N
N-
N+
O
(A) 100 mg
Dimetindene Maleate MM 0595.01 Imp. A (EP): 2-Ethylpyridine N (B) 100 mg
Diphemanil Metilsulfate MM 1163.00 Diphemanil Metilsulfate N+
OS
O
O Ox
-
(D) 100 mg
Diphenhydramine Hydrochloride MM 0490.00 Diphenhydramine Hydrochloride
ON
x HCl
(A) 500 mg
MM 0490.03 Imp. A (EP) as Hydrochloride: 2-(Diphenylmethoxy)-N-methylethanamine Hydrochloride (Nordiphenhydramine Hydrochloride)
OHN
x HCl
(A) 100 mg
MM 0490.04 Imp. B (EP) as Hydrochloride: 2-[(RS)- (4-Methylphenyl)phenylmethoxy]-N,N- dimethylethanamine Hydrochloride (4-Methyldiphenhydramine Hydrochloride O
Nx HCl
(A) 100 mg
MM 0640.00 Imp. C (EP) as Hydrochloride: 2-[(RS)- (4-Bromophenyl)phenylmethoxy]-N,N- dimethylethanamine Hydrochloride (Bromazine Hydrochloride) O
Nx HCl
Br
(A) 100 mg
MM 0490.02 Imp. D (EP): Diphenylmethanol (Benzhydrol)
OH
(B) 100 mg
Pharmaceutical impurities
70 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0630.01 Imp. E (EP): Diphenylmethanone (Benzophenone)
O
(B) 100 mg
MM 0490.01 Diphenhydramine N-Oxide
ON
O
(A) 100 mg
Diphenylpyraline Hydrochloride MM 0557.00 Diphenylpyraline Hydrochloride
O
Nx HCl
(A) 500 mg
MM 0155.01 Diphenylpyraline O
N
(A) 100 mg
MM 0490.02 Diphenylmethanol (Benzhydrol) OH
(B) 100 mg
MM 0630.01 Diphenylmethanone (Benzophenone) O
(B) 100 mg
MM 0557.04 Diphenylpyraline N-Oxide O
NO
(A) 100 mg
MM 0468.04 N-Desmethyldiphenylpyraline Hydrochloride (4-(Diphenylmethoxy)piperidine Hydrochloride)
O
NH x HCl
(A) 100 mg
Dipipanone Hydrochloride MM 0760.01 1,1-Diphenylbut-1-ene (A) 100 mg
MM 0760.02 1-(1-Methyl-3,3-diphenylpropyl)piperidine Hydrochloride
N
x HCl
(A) 100 mg
Dipotassium Clorazepate MM 0028.03 Imp. A (EP): (2-Amino-5-chlorophenyl)phenylmethanone
(Aminochlorobenzophenone) Cl
NH2
O
(B) 100 mg
MM 0023.02 Imp. B (EP): 7-Chloro-5-phenyl-1,3-dihydro-2H- 1,4-benzodiazepin-2-one (Nordazepam) [Controlled Substance] N
HN
O
Cl
(A) 100 mg
Diprafenon Hydrochloride MM 0428.01 2'-Hydroxy-3-phenylpropiophenone O
OH
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 71
Code Product Code Unit
Diprophylline MM 0176.01 Imp. A (Pharmeuropa): N-Methyl-5-(methylamino)-1H-imidazole-
4-carboxamide (Theophyllidine) NH
HN N
HN
O (A) 100 mg
MM 0176.00 Imp. B (Pharmeuropa): 1,3-Dimethyl-3,7-dihydro-1H-purine-2,6-dione (Theophylline) N
N N
HN
O
O
(A) 500 mg
MM 0603.00 Imp. C (Pharmeuropa): 7-(2-Hydroxyethyl)-1,3-dimethyl-3,7-dihydro-1H-purine-2,6-dione (Etofylline) N
N N
N
O
O
OH(A) 500 mg
Dipyridamole MM 0462.03 Imp. C (EP): 2,2'-[[6-Chloro-4,8-di(piperidin-1-
yl)pyrimido[5,4-d]pyrimidin-2-yl]nitrilo]diethanol
N
NN
N
N
Cl
N
N
OH
OH
(A) 100 mg
Disopyramide MM 0108.00 Disopyramide
O
NH2
N
N
(A) 500 mg
Dithranol MM 0137.00 Dithranol OHOOH (A) 500 mg
MM 0137.04 Imp. A (EP): Anthracen-9(10H)-one (Anthrone) O (A) 100 mg
MM 0137.01 Imp. B (EP): 1,8-Dihydroxyanthracene-9,10-dione (Danthron) OHOOH
O
(A) 100 mg
MM 0137.02 Imp. C (EP): 4,4',5,5'-Tetrahydroxy-9,9'-bianthracenyl-10,10'(9H,9'H)-dione (Dithranol Dimer)
OHOOH
OH O OH
(A) 100 mg
Dobutamine Hydrochloride MM 0384.00 Imp. A (EP) as Hydrochloride: Dopamine Hydrochloride HO
HO
NH2
x HCl(A) 500 mg
MM 0675.02 Imp. B (EP): 4-(4-Hydroxyphenyl)butan-2-one O
OH (C) 100 mg
Dodecylguanidinium Acetate MM 0451.03 Dodecylnitrile N (B) 100 mg
MM 0451.05 Dimethyldodecylamine N
(B) 100 mg
Phytochemical reference standards from ChromaDexMore than 2500 reference substances for phytochemical analysis
• Certified Reference Materials (CRM)
• Botanical Reference Materials (BRM)
• Extract Reference Materials (XRM)
• Standards with various documentation grades
• Reference standard kits
• Analytical methods.
Reference standards for/from:
• Artichoke
• Belladonna
• Bilbery
• Black Cohosh
• Carotenoids
• Cat’s Claw
• Devil’s Claw
• Echinacea
• Ephedra
• Ginseng
• Kava Kava
• Reishi Mushroom
• Rosemary
• Soysaponins
• St. John’s Wort
• Tribulus Terrestris
• Valerian
• ... and many more.
www.lgcstandards.com
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 73
Code Product Code Unit
Domperidone MM 0107.00 Domperidone
N NHNNHN
O O
Cl
(D) 100 mg
MM 0107.06 Imp. A (EP): 5-Chloro-1-(piperidin-4-yl)-1,3-dihydro-2H-benzimidazol-2-one HN NHN
O
Cl
(A) 100 mg
MM 0107.05 Imp. B (EP): 4-(5-Chloro-2-oxo-2,3-dihydro-1H-benzimidazol-1-yl)-1-formylpiperidine N NHN
O
Cl
O (A) 100 mg
MM 0107.03 Imp. F (EP): 1,3-Bis[3-[4-(5-chloro-2-oxo-2,3-dihydro-1H-benzimidazol-1-yl)piperidin-1-yl]propyl]-1,3-dihydro-2H-benzimidazol-2-one
N NHNNN
O O
Cl
NHN N
O
Cl
(A) 50 mg
MM 0107.07 1,3-Dihydro-2H-benzimidazol-2-one HN
NH
O(B) 100 mg
Donepezil Hydrochloride MM 0677.00 Donepezil Hydrochloride
O
O
ON
x HCl
(D) 100 mg
MM 0677.01 Donepezil
O
O
ON
(D) 100 mg
Dopamine Hydrochloride MM 0384.00 Dopamine Hydrochloride HO
HO
NH2x HCl
(A) 500 mg
MM 0384.02 Imp. A (EP) as Hydrochloride: 5-(2-Aminoethyl)- 2-methoxyphenol Hydrochloride (4-O-Methyldopamine Hydrochloride)
HO
O
NH2x HCl
(A) 100 mg
MM 0384.04 Imp. C (EP): 2-(3,4-Dimethoxyphenyl)ethanamine O
O
NH2 (A) 100 mg
MM 0384.01 (R,S)-�-Methyldopamine Hydrobromide HO
HO
NH2x HBr
(A) 100 mg
Dosulepin Hydrochloride MM 0510.00 Dosulepin Hydrochloride
x HCl
N
S
(A) 100 mg
MM 0510.02 Imp. B (EP): Dibenzo[b,e]thiepin-11(6H)-one O
S
(A) 100 mg
MM 0510.08 Nordosulepin Hydrochloride
x HCl
NH
S
(A) 50 mg
Pharmaceutical impurities
74 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Doxazosin Mesilate MM 0386.00 Doxazosin Mesilate
N
NO
ONH2
N
N
O
O
O
SOH
OOx
(A) 100 mg
MM 0386.08 Doxazosin
N
NO
O
NH2
N
N
O
O
O(A) 100 mg
MM 0386.04 Imp. A (EP): (2RS)-2,3-Dihydro-1,4-benzodioxine-2-carboxylic Acid
OOHO
O (A) 100 mg
MM 0386.05 Imp. B (EP) as Hydrochloride: 1-[(2RS)-2,3-Dihydro-1,4-benzodioxin-2-ylcarbonyl]piperazine Hydrochloride
OON
O
HNx HCl
(A) 100 mg
MM 0386.06 Imp. C (EP): 1,4-Bis(2,3-dihydro-1,4-benzodioxin- 2-ylcarbonyl)piperazine
O
ON
O
N
O
O
O
(A) 100 mg
MM 0085.07 Imp. D (EP): 6,7-Dimethoxyquinazoline-2,4(1H,3H)-dione
NH
HNO
O
O
O
(C) 100 mg
MM 0085.06 Imp. E (EP): 2,4-Dichloro-6,7-dimethoxyquinazoline N
NO
O
Cl
Cl
(A) 100 mg
MM 0386.01 Imp. F (EP): 2-Chloro-6,7-dimethoxyquinazolin-4-amine N
N
O
O
Cl
NH2
(A) 100 mg
MM 0386.12 Imp. F (EP) as Mesilate: 2-Chloro-6,7-dimethoxy- quinazolin-4-amine Mesilate N
NO
O
NH2
Cl
SOH
OOx
(A) 100 mg
MM 0085.01 Imp. G (EP): 6,7-Dimethoxy-2-(piperazin-1-yl)quinazolin-4-amine
N
NO
O
N
NH2
NH (A) 100 mg
MM 0085.03 Imp. H (EP): 2,2'-(Piperazine-1,4-diyl)bis(6,7-dimethoxyquinazolin-4-amine)
N
NO
O
N
NH2
N N
NO
O
NH2 (D) 100 mg
Doxepin Hydrochloride MM 0032.00 Doxepin Hydrochloride
O
N
x HCl
(A) 500 mg
New MM 0032.03 Imp. A (EP): Dibenzo[b,e]oxepin-11(6H)-one (Doxepinone) O
O
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 75
Code Product Code Unit
New MM 0032.04 Imp. B (EP): (11RS)-11-[3-(Dimethylamino)- propyl]-6,11-dihydrodibenzo[b,e]oxepin- 11-ol (Doxepinol)
O
OHN (A) 50 mg
Doxylamine Hydrogen Succinate MM 0101.00 Doxylamine Hydrogen Succinate
NO
NOH
O
OH
O
x
(A) 500 mg
New MM 0101.02 Imp. B (EP) as Hydrochloride: (1RS)-1-Phenyl- 1-(pyridin-2-yl)ethanol Hydrochloride
NOH
x HCl
(A) 50 mg
New MM 0101.03 Imp. C (EP) as Hydrogen Fumarate: N,N- Dimethyl-2-[(RS)-1-phenyl(pyridin-2-yl)- methoxy]ethanamine Hydrogen Fumarate N
ON
OH
O
HO
O
x
(A) 50 mg
MM 0101.04 Imp. D (EP): Phenyl(pyridin-2-yl)methanone (2-Benzoylpyridine)
NO
(A) 100 mg
MM 0101.05 Doxylamine N-Oxide Dihydrochloride
NO
NO x 2 HCl
(A) 100 mg
Drofenine Hydrochloride MM 0768.00 Drofenine Hydrochloride
O
O
Nx HCl
(A) 500 mg
MM 0768.01 Drofenine N-Oxide Hydrochloride
O
O
Nx HCl
O
(A) 100 mg
Droperidol MM 0138.01 Imp. A (EP): 1-(1,2,3,6-Tetrahydropyridin-
4-yl)-1,3-dihydro-2H-benzimidazol-2-one HN
N
NHO
(A) 50 mg
MM 0138.04 Imp. D (EP) as Hydrochloride: (1RS)- 1-[4-(4-Fluorophenyl)-4-oxobutyl]- 4-(2-oxo-2,3-dihydro-1H- benzimidazol-1-yl)-1,2,3,6-tetrahydro- pyridine 1-Oxide Hydrochloride
N
NO
F
NHO
O
x HCl
(A) 100 mg
Dropropizine MM 1017.00 Dropropizine
N
N
OH
OH (A) 500 mg
Duloxetine Hydrochloride New MM 0043.04 Imp. D (Pharmeuropa): Naphthalen-1-ol (1-Naphthol)
OH
(B) 100 mg
Pharmaceutical impurities
76 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Ebastine MM 0468.00 Ebastine
O
NO
(A) 100 mg
MM 0490.02 Imp. A (EP): Diphenylmethanol (Benzhydrol)
OH
(B) 100 mg
MM 0468.03 Imp. B (EP): 1-[4-(1,1-Dimethylethyl)phenyl]ethanone
O
(A) 100 mg
MM 0468.04 Imp. C (EP) as Hydrochloride: 4-(Diphenyl- methoxy)piperidine Hydrochloride
O
NH x HCl
(A) 100 mg
MM 0468.05 Imp. D (EP): 1-[4-(1,1-Dimethylethyl)phenyl]- 4-(4-hydroxypiperidin-1-yl)butan-1-one
HO
NO
(A) 100 mg
MM 0468.06 Imp. E (EP) as Hydrogen Fumarate: 1-[4-(1,1-Dimethylpropyl)phenyl]- 4-[4-(diphenylmethoxy)piperidin- 1-yl]butan-1-one Hydrogen Fumarate
O
NO
O
OHHO
O
x
(A) 100 mg
Econazole Nitrate MM 0524.00 Econazole Nitrate
O
Cl
x HNO3
N
N
Cl
Cl (A) 500 mg
MM 0281.01 Imp. A (EP): (1RS)-1-(2,4-Dichlorophenyl)-2-(1H-imidazol-1-yl)ethanol
HON
N
Cl
Cl (A) 100 mg
MM 0524.02 Imp. B (EP) as Nitrate: (2RS)-2-[(4-Chlorobenzyl)oxy]-2-(2,4-dichlorophenyl) ethanamine Nitrate
O
Cl
x HNO3
NH2
Cl
Cl (D) 100 mg
MM 0524.03 Imp. C (EP) as Chloride: 1-(4-Chlorobenzyl)- 3-[(2RS)-2-[(4-chlorobenzyl)oxy]- 2-(2,4-dichlorophenyl)ethyl] imidazolium Chloride
O
ClN+
N
Cl
Cl
Cl
Cl-
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 77
Code Product Code Unit
Emedastine Difumarate New MM 1277.02 Imp. B (EP): 2-Chloro-1-(2-ethoxyethyl)-1H-
Benzimidazole
N
N Cl
O (A) 100 mg
Enalapril Maleate MM 0010.00 Enalapril Maleate
HN
O O
N
O
OHOH
O
O
x
OOH (A) 100 mg
MM 0010.05 Imp. B (EP): (2S)-2-[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]propanoic Acid
HN
O O
OH
O (A) 100 mg
MM 0010.01 Imp. C (EP): (2S)-1-[(2S)-2-[[(1S)-1-Carboxy- 3-phenylpropyl]amino]propanoyl]pyrrolidine-2- carboxylic Acid (Enalaprilat)
HN
HO O
N
OO
OH (D) 100 mg
MM 0010.06 Imp. D (EP): Ethyl (2S)-2-[(3S,8aS)-3-Methyl-1,4-dioxo-octahydropyrrolo[1,2-�]pyrazin-2-yl]-4-phenylbutanoate (Enalapril diketopiperazine) N
O O
O
NO
H (A) 100 mg
MM 0015.02 Imp. I (EP): 1H-Imidazole (Imidazole) N
HN (B) 100 mg
MM 0010.15 (2S)-2[[(1S)-1-(Ethoxycarbonyl)-3-phenylpropyl]amino]propanoic Acid Ethyl Ester Hydrochloride
HN
O O
O
O
x HCl
(A) 100 mg
Enilconazole MM 0281.01 Imp. E (EP): (1RS)-1-(2,4-Dichlorophenyl)-2-(1H-imidazol-1-yl)ethanol
NHO
N
Cl
Cl (A) 100 mg
Enrofloxacin MM 0395.00 Enrofloxacin
NN
O
OH
O
N
F
(A) 100 mg
MM 00018.01 Imp. A (EP): 7-Chloro-1-cyclo- propyl-6-fluoro-4-oxo-1,4-dihydroquinoline- 3-carboxylic Acid
NCl
O
OH
OF
(A) 100 mg
MM 0018.06 Imp. B (EP) as Hydrochloride Monohydrate: Ciprofloxacin Hydrochloride Monohydrate NN
O
OH
O
HN
F
x HClx H2O
(A) 500 mg
MM 0395.01 Imp. C (EP) as Hydrochloride: 1-Cyclopropyl-7-(4-ethylpiperazin-1-yl)-4- oxo-1,4-dihydroquinoline-3-carboxylic Acid Hydrochloride (Desfluoroenrofloxacin Hydrochloride)
NN
O
OH
O
N
x HCl
(A) 100 mg
Pharmaceutical impurities
78 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0018.04 Imp. G (EP): 7-[(2-Aminoethyl)amino]-1-cyclopropyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid NHN
O
OH
O
H2N
F
(D) 50 mg
MM 0395.07 Enrofloxacin N-Oxide Hydrochloride
NN
O
OH
O
N
F
O
x HCl
(A) 100 mg
Entacapone New MM 1221.04 Imp. B (EP): Ethyl (2E)-2-Cyano-3-(3,4-
dihydroxy-5-nitrophenyl)prop-2-enoate O2N
HO
OHN
O
O (A) 50 mg
New MM 1221.03 Imp. H (EP): (2E)-3-(3,4-Dihydroxy-5-nitro- phenyl)-2-(piperidin-1-ylcarbonyl)prop-2- ennitrile
O2N
HO
OHN
N
O (A) 50 mg
MM 1221.09 Imp. I (EP): Propyl (2E)-2-Cyano-3-(3,4- dihydroxy-5-nitrophenyl)prop-2-enoate O2N
HO
OHN
O
O (A) 50 mg
MM 1221.01 Imp. C (Pharmeuropa): 3,4-Dihydroxy-5-nitro- benzaldehyde
O2N
HOOH
O (A) 100 mg
New MM 1221.05 Imp. D (EP): (2E)-2-Cyano-3-(3-ethoxy-4- hydroxy-5-nitrophenyl)-N,N-diethylprop-2- enamide
O2N
HO
ON
N
O (A) 50 mg
New MM 1221.06 Imp. E (EP): 3,5-Dinitrobenzene-1,2-diol O2N
HOOH
NO2 (A) 50 mg
New MM 1221.07 Imp. F (EP): (2E)-2-Cyano-3-(3,4-dihydroxy- 5-nitrophenyl)prop-2-enoic Acid O2N
HO
OHN
O
OH
(A) 50 mg
Ephedrine Hydrochloride MM 0652.00 Ephedrine Hydrochloride
[Drug Precursor]HN
OH
x HCl(A) 500 mg
MM 2115.00 Imp. B (EP) as Hydrochloride: Pseudoephedrine Hydrochloride [Drug Precursor]
HN
OH
x HCl
(A) 500 mg
Ephedrine Sulphate MM 1147.00 Ephedrine Sulphate
[Drug Precursor] HN
OH
2
x H2SO4
(A) 250 mg
Erdosteine MM 0544.00 Erdosteine
NH
SOH
OOS O (A) 100 mg
MM 0544.01 2-Chloro-N-(2-oxotetrahydrothiophen-3-yl)acetamide NH
ClOS O (A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 79
Code Product Code Unit
Erythromycin MM 0132.13 Imp. B (EP): N-Demethylerythromycin A O
O
HOOH
O
HO
O
O
O
OH
OO
NH
OH
(D) 100 mg
MM 0132.10 Imp. E (EP): Erythromycin A Enol Ether O
O
HOOH
OO
O
O
OH
OO
N
OH
(A) 50 mg
Esomeprazole Magnesium Trihydrate MM 0095.03 Imp. A (EP): 5-Methoxy-1H-benzimidazole-2-thiol
SH
NH
N
O (A) 100 mg
MM 0095.04 Imp. B (EP): 2-[(RS)-[(3,5-Dimethylpyridin- 2-yl)methyl]sulphinyl]-5-methoxy-1H-benzimidazole
N
S
O
NH
N
O (A) 100 mg
MM 0095.06 Imp. C (EP): 5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]- sulphanyl]-1H-benzimidazole (Ufiprazole)
N
OS
NH
N
O (A) 100 mg
MM 0095.05 Imp. D (EP): 5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl] -sulphonyl]-1H-benzimidazole (Omeprazole Sulphone)
N
OS
NH
N
O
O O
(A) 100 mg
MM 0095.07 Imp. E (EP): 4-Methoxy-2-[[(RS)-(5-methoxy-1H-benzimidazol-2-yl) -sulphinyl]methyl]-3,5-dimethylpyridine 1-Oxide (Omeprazole N-Oxide) N
OS
O
NH
N
O
O
(A) 100 mg
Estradiol Benzoate MM 0301.00 Estradiol Benzoate OH
O
O
(A) 500 mg
MM 0300.00 Imp. A (EP) as Hemihydrate: Estradiol Hemihydrate OH
HO
x 1/2 H2O
(A) 500 mg
MM 0301.02 Imp. C (EP): Estra-1,3,5(10)-triene-3,17�-diyl Dibenzoate (Estradiol 3,17-Dibenzoate) O
O
O
O (A) 100 mg
MM 0301.07 Imp. D (EP): 3-Hydroxyestra-1,3,5(10)-trien-17�-yl Benzoate (Estradiol 17-Benzoate) O
HO
O (A) 100 mg
MM 0301.03 Imp. E (EP): 17�-Hydroxyestra-1,3,5(10)-trien-3-yl Benzoate (17-epi-Estradiol Benzoate)
OH
O
O
(C) 10 mg
Pharmaceutical impurities
80 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0301.08 Imp. G (EP): 17-Oxoestra-1,3,5(10)-trien-3-yl Benzoate (Estrone Benzoate)
O
O
O
(A) 100 mg
MM 0278.01 Benzoic Acid OH
O (B) 100 mg
Estradiol Enanthate MM 0473.00 Estradiol Enanthate
O
HO
O (A) 100 mg
Estradiol Hemihydrate MM 0300.00 Estradiol Hemihydrate OH
HO
x 1/2 H2O
(A) 500 mg
MM 0282.00 Imp. A (EP): 3-Hydroxyestra-1,3,5(10)-trien-17-one (Estrone) O
HO
(A) 500 mg
MM 0300.01 Imp. B (EP): Estra-1,3,5(10)-triene-3,17�-diol (17�-Estradiol; 17-epi-Estradiol)
OH
HO
(A) 100 mg
MM 0300.06 Imp. C (EP): 4-Methylestra-1,3,5(10)-triene-3,17�-diol (4-Methylestradiol)
OH
HO
(A) 100 mg
MM 0300.02 Imp. D (EP): Estra-1,3,5(10),9(11)-tetraene-3,17�-diol (9,11-Didehydroestradiol)
OH
HO
(D) 100 mg
MM 0300.03 6�-Hydroxyestradiol OH
HOOH
(D) 50 mg
MM 0300.08 6-Ketoestradiol OH
HO
O
(A) 100 mg
Estradiol Valerate MM 0209.00 Estradiol Valerate
O
HO
O (A) 500 mg
MM 0300.00 Imp. A (EP) as Hemihydrate:Estradiol Hemihydrate OH
HO
x 1/2 H2O
(A) 500 mg
MM 0209.06 Imp. B (EP): 17�-Hydroxyestra-1,3,5(10)-trien-3-yl Pentanoate (Estradiol 3-Valerate)
OH
O
O
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 81
Code Product Code Unit
MM 0209.01 Imp. C (EP): 3-Hydroxyestra-1,3,5(10),9(11)-tetraen-17�-yl Pentanoate (9,11-Didehydroestradiol Valerate) O
HO
O (D) 100 mg
MM 0209.07 Imp. D (EP): 3-Hydroxy-4-methylestra-1,3,5(10)-trien-17�-yl Pentanoate (4-Methylestradiol Valerate)
O
HO
O (D) 100 mg
MM 0209.02 Imp. E (EP): Estra-1,3,5(10)-trien-3,17�-diyl Dipentanoate (Estradiol 3,17-Divalerate) O
O
O
O
(A) 100 mg
MM 0209.04 Imp. F (EP): 3-Hydroxyestra-1,3,5(10)-trien-17�-yl Butanoate (Estradiol Butyrate) O
HO
O (A) 100 mg
MM 0209.03 17-epi-Estradiol Valerate (17�-Estradiol Valerate) O
HO
O (D) 100 mg
Estramustine Sodium Phosphate MM 0100.01 Estramustine OH
ON
O
Cl
Cl
(D) 100 mg
MM 0100.02 17�-17'�-Bis3-{bis(2-chloroethyl)carbamoyl- oxy}estra-1,3,5(10)-trienyl Pyrophosphate Disodium Salt
O
ON
O
Cl
Cl
PO
PO
NaO O O ONa
O N
OCl
Cl
(D) 50 mg
Estriol MM 0130.00 Estriol OH
HO
OH
(A) 100 mg
MM 0130.06 Imp. A (EP): Estra-1,3,5(10),9(11)-tetraene-3,16�,17�-triol (9,11-Didehydroestriol)
OH
HO
OH
(D) 100 mg
MM 0282.00 Imp. B (EP): 3-Hydroxyestra-1,3,5(10)-trien-17-one (Estrone) O
HO
(A) 500 mg
MM 0130.01 Imp. C (EP): 3-Methoxyestra-1,3,5(10)-triene-16�,17�-diol (Estriol 3-Methyl Ether)
OH
O
OH
(D) 100 mg
MM 0300.00 Imp. D (EP) as Hemihydrate: Estradiol Hemihydrate
OH
HO
x 1/2 H2O
(A) 500 mg
MM 0130.05 Imp. E (EP): Estra-1,3,5(10)-triene-3,16�,17�-triol (17-epi-Estriol)
OH
HO
OH
(D) 100 mg
Pharmaceutical impurities
82 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0130.04 Imp. F (EP): Estra-1,3,5(10)-triene-3,16�,17�-triol (16-epi-Estriol)
OH
HO
OH
(D) 100 mg
MM 0130.03 Imp. G (EP): Estra-1,3,5(10)-triene-3,16�,17�-triol (16,17-epi-Estriol)
OH
HO
OH
(D) 100 mg
MM 0130.22 Imp. I (EP): 3-Hydroxy-17-oxa-D-homoestra-1,3,5(10)-trien-17a-one
HO
O
O on request
MM 0130.02 6�-Hydroxyestriol OH
HO
OH
OH
(D) 100 mg
MM 0130.14 Estriol 16,17-Diacetate O
HO
O
O
O
(D) 100 mg
MM 0130.15 Estriol Triacetate O
O
O
O
OO
(D) 100 mg
MM 0130.16 Estriol 3-Benzyl Ether OH
O
OH
(D) 100 mg
MM 0130.17 16-Oxoestradiol OH
HO
O
(D) 100 mg
MM 0130.18 6-Oxoestriol OH
HO
OH
O
(D) 100 mg
Estrogens conjugated New MM 0282.00 Estrone O
HO
(A) 500 mg
Estrone MM 0282.00 Estrone O
HO
(A) 500 mg
MM 0282.01 Estrone 3-Methyl Ether O
O
(A) 100 mg
Ethacridine Lactate Monohydrate MM 0798.00 Ethacridine Lactate Monohydrate
NH2N
NH2
O
OH
O
OH xx H2O
(A) 250 mg
Ethinylestradiol MM 0123.00 Ethinylestradiol OH
HO
(A) 500 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 83
Code Product Code Unit
MM 0123.02 Imp. B (EP): 19-Nor-17�-pregna-1,3,5(10),9(11)-tetraen-20-yne-3,17-diol (9,11-Didehydroethinylestradiol)
OH
HO
(D) 50 mg
MM 0282.00 Imp. C (EP): 3-Hydroxyestra-1,3,5(10)-trien-17-one (Estrone) O
HO
(A) 500 mg
MM 0300.00 Imp. D (EP) as Hemihydrate: Estradiol Hemihydrate
OH
HO
x 1/2 H2O
(A) 500 mg
MM 0123.07 Imp. E (EP): 19-Nor-17�-pregna- 1,3,5(10)-trien-20-yne-3,6�,17-triol (6�-Hydroxyethinylestradiol)
OH
HOOH
(D) 100 mg
MM 0123.06 Imp. F (EP): 19-Nor-17�-pregna- 1,3,5(10)-trien-20-yne-3,6�,17-triol (6�-Hydroxyethinylestradiol)
OH
HOOH
(D) 25 mg
MM 0123.05 Imp. G (EP): 3,17-Dihydroxy-19- nor-17�-pregna-1,3,5(10)-trien-20-yn-6-one (6-Oxoethinylestradiol, 6-Ketoethinylestradiol)
OH
HOO
(D) 100 mg
MM 0123.08 Imp. I (EP): 19-Nor-17�-pregna- 1,3,5(10),6-tetraen-20-yne-3,17-diol (6,7-Didehydroethinylestradiol)
HO
OH (D) 50 mg
MM 0300.01 Imp. L (EP): Estra-1,3,5(10)-triene- 3,17�-diol (17�-Estradiol; 17-epi-Estradiol)
OH
HO
(A) 100 mg
Ethionamide MM 0845.00 Ethionamide
NNH2
S (A) 250 mg
MM 0845.01 Ethionamide Sulphoxide
N
NH2
SO (D) 100 mg
Ethosuximide MM 0750.00 Ethosuximide H
N OO(A) 500 mg
Ethyl Parahydroxybenzoate MM 0498.00 Ethyl Parahydroxybenzoate
HO
O
O (A) 500 mg
MM 0498.05 Sodium Ethyl Parahydroxybenzoate
NaO
O
O (A) 500 mg
MM 0045.01 Imp. A (EP): 4-Hydroxybenzoic Acid
HO
OH
O (B) 100 mg
MM 0431.00 Imp. B (EP): Methyl 4-Hydroxybenzoate (Methyl Parahydroxybenzoate)
HO
O
O (A) 500 mg
MM 0432.00 Imp. C (EP): Propyl 4-Hydroxybenzoate (Propyl Parahydroxybenzoate)
HO
O
O (A) 500 mg
Pharmaceutical impurities
84 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0496.00 Imp. D (EP): Butyl 4-Hydroxybenzoate (Butyl Parahydroxybenzoate)
HO
O
O (A) 500 mg
Ethylmorphine Hydrochloride MM 0037.00 Imp. B (EP) as Hydrochloride Trihydrate:
Morphine Hydrochloride Trihydrate [Controlled Substance]
O OHHO
N
x HClx 3 H2O
(A) 250 mg
MM 0280.00 Imp. B (EP) as Hemisulphate Pentahemihydrate: Morphine Hemisulphate Pentahemihydrate [Controlled Substance]
O OHHO
N
2
x H2SO4x 5 H2O
(A) 250 mg
MM 0004.00 Imp. C (EP) as Monohydrate: Codeine Monohydrate [Controlled Substance]
O OHO
N
x H2O
(A) 100 mg
MM 0442.00 Imp. C (EP) as Phosphate Hemihydrate: Codeine Phosphate Hemihydrate [Controlled Substance]
O OHO
N
x H3PO4x 1/2 H2O
(A) 100 mg
Etilefrine Hydrochloride MM 0035.00 Etilefrine Hydrochloride
HOOH H
N x HCl(A) 500 mg
MM 0081.00 Imp. B (EP) as Hydrochloride: (1RS)- 1-(3-Hydroxyphenyl)-2-(methylamino)ethanol Hydrochloride (Phenylephrine Hydrochloride)
HO
OHHN x HCl
(A) 500 mg
MM 0973.00 Imp. C (EP) as Hydrochloride: (1RS)-2-Amino-1-(3-hydroxyphenyl)ethanol Hydrochloride (Norfenefrine Hydrochloride)
HO
OH
NH2 x HCl(A) 500 mg
MM 0035.05 Imp. E (EP): 1-(3-Hydroxyphenyl)ethanone (3-Hydroxyacetophenone) HO
O (C) 100 mg
MM 0035.06 Imp. F (EP): N-Benzylethanamine (Benzylethylamine)
HN
(C) 100 mg
New MM 0035.08 Imp. D (EP) as Hydrochloride: 2-(Benzylethyl-amino)-1-(3-hydroxyphenyl)ethanone Hydro-chloride (Benzyletilefrone Hydrochloride) HO
ON
x HCl
(A) 100 mg
MM 0035.50 3-Benzoyloxyacetophenone O
O
O
(A) 100 mg
MM 0035.51 3-Benzoyloxy-�-bromoacetophenone O
O
O
Bron request
Etodolac MM 0911.00 Etodolac
OHN
O
OH
(A) 250 mg
MM 0911.01 Imp. A (EP): 2-[(1RS)-1-Ethyl-1,3,4,9-tetrahydro- pyrano[3,4-b]indol-1-yl]acetic Acid (8-Desethyl Etodolac) O
HN
O
OH
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 85
Code Product Code Unit
MM 0911.02 Imp. B (EP): 2-[(1RS)-1-Ethyl-8-methyl-1,3,4,9- tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid (8-Methyl Etodolac) O
HN
O
OH
(A) 100 mg
MM 0911.03 Imp. C (EP): 2-[(1RS)-8-Ethyl-1-methyl-1,3,4,9- tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid (1-Methyl Etodolac) O
HN
O
OH
(A) 100 mg
New MM 0911.04 Imp. D (EP): 2-[(1RS)-1-Ethyl-8-(1-methylethyl)- 1,3,4,9-tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid (8-Isopropyl Etodolac) O
HN
O
OH
(A) 50 mg
MM 0911.06 Imp. F (EP): 2-[(1RS)-8-Ethyl-1-(1-methylethyl)- 1,3,4,9-tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid (1-Isopropyl Etodolac) O
HN
O
OH
(A) 100 mg
MM 0911.07 Imp. G (EP): 2-[(1RS)-8-Ethyl-1-propyl-1,3,4,9- tetrahydropyrano[3,4-b]indol-1-yl]acetic Acid (1-Propyl Etodolac) O
HN
O
OH
(A) 100 mg
MM 0911.08 Imp. H (EP): 2-(7-Ethylindol-3-yl)ethanol OH
HN (A) 100 mg
MM 0911.10 Imp. J (EP): (1RS)-1,8-Diethyl-1-methyl-1,3,4,9- tetrahydropyrano[3,4-b]indole (Decarboxy Etodolac O
HN
(A) 100 mg
MM 0911.11 Imp. K (EP): Methyl 2-[(1RS)-1,8-Diethyl-1,3,4,9- tetrahydropyrano[3,4-b]indol-1-yl]acetate (Etodolac Methyl Ester) O
HN
O
O
(A) 100 mg
Etofenamate MM 0410.00 Imp. A (EP): 2-[[3-(Trifluoromethyl)phenyl]-amino]benzoic Acid
(Flufenamic Acid) O
OH
NH
F
F F
(A) 500 mg
MM 0105.02 Imp. B (EP): Butyl 2-[[3-(Trifluoromethyl)phenyl]-amino]benzoate (Butyl Flufenamate)
O
O
NH
F
F F
(A) 100 mg
MM 0105.03 Imp. C (EP): N-Phenyl-3-(trifluoromethyl)aniline NH
F
F F
(A) 100 mg
MM 0105.04 Imp. D (EP): 2,2'-Oxybis(ethylene) Bis[2-[[3-(trifluoromethyl)phenyl] amino]benzoate]
O
O
NH
F
O
O
HN
F
O
F F F F
(A) 100 mg
Pharmaceutical impurities
86 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0105.05 Imp. E (EP): 2-(2-Butoxyethoxy)ethyl 2-[[3- (Trifluoromethyl)phenyl]amino]benzoate
O
O
NH
F
OO
F F
(A) 100 mg
MM 0105.06 Imp. F (EP): 2,2'-Oxydiethanol HOO
OH (A) 100 mg
MM 0105.07 Imp. G (EP): 2-Hydroxyethyl 2-[[3-(Trifluoromethyl)phenyl]amino]benzoate
O
O
NH
F
OH
F F
(A) 100 mg
MM 0105.08 Etofenamate Myristate O
O
NH
F
OO
O
F F
(A) 100 mg
MM 0105.09 Etofenamate Palmitate O
O
NH
F
OO
O
FF
(A) 100 mg
MM 0105.10 Etofenamate Stearate O
O
NH
F
OO
O
F F
(A) 100 mg
MM 0105.11 Triethylene Glycol Flufenamate O
O
NH
F
OO
OH
F F
(A) 100 mg
Etofylline MM 0603.00 Etofylline
N
N N
N
O
OOH
(A) 500 mg
Famciclovir New MM 0620.01 9-[4-Acetoxy-3-(acetoxymethyl)butyl]-2-amino-
6-chloropurine N
N N
N
H2NO
O
O
O
Cl 100 mg
Famotidine MM 0029.00 Famotidine
S N
NH2
N
SN
H2NNH2
SNH2
O O
(A) 250 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 87
Code Product Code Unit
MM 0029.06 Imp. A (EP) as Hydrochloride: 3-[[[2- [(Diaminomethylene)amino]thiazol-4-yl]- methyl]sulphanyl]propanimidamide Hydrochloride
S NH2
NH
N
SN
H2NNH2
x HCl(A) 100 mg
MM 0029.05 Imp. B (EP) as Dimaleate: 3,5-Bis[2-[[[2-[(diaminomethylene)amino]thiazol-4-yl]-methyl]sulphanyl]ethyl]-4H-1,2,4,6-thiatriazine 1,1-Dioxide Dimaleate
SN
SN
NH
NS
N
O O
S N
SN
H2NNH2
NH2
H2N
OHOH
O
O
x 2
(D) 50 mg
MM 0029.01 Imp. C (EP) as Hydrochloride: 3-[[[2-[(Diaminomethylene)amino]thiazol-4-yl]methyl]sulphanyl]-N-sulphamoylpropanamide Hydrochloride
S NH
O
N
SN
H2NNH2
SNH2
O O
x HCl
(A) 100 mg
MM 0029.02 Imp. D (EP): 3-[[[2-[(Diaminomethylene)amino]thiazol-4-yl]methyl]sulphanyl]propanamide S NH2
O
N
SN
H2NNH2 (A) 100 mg
MM 0029.07 Imp. E (EP): 2,2'-[Disulphanediylbis-(methylenethiazole-4,2-diyl)]diguanidine SN
SN
H2NNH2
S
S
NN
NH2
H2N (A) 100 mg
MM 0029.03 Imp. F (EP): 3-[[[2-[(Diaminomethylene)amino]thiazol-4-yl]methyl]sulphanyl]propanoic Acid S OH
O
N
SN
H2NNH2 (A) 100 mg
MM 0029.09 Imp. G (EP) as Maleate: N-Cyano-3-[[[2-(diaminomethylene)amino]thiazol-4-yl]methyl]sulphanyl]propanimidamide Maleate
S NH
NH
N
SN
H2NNH2 N
OHOH
O
O
x
(A) 100 mg
MM 0029.04 Famotidine Sulphoxide S N
NH2
N
SN
H2NNH2
SNH2
O OO
(A) 100 mg
MM 0029.10 3-[[[2-[(Diaminomethylene)amino]thiazol-4-yl]methyl]sulphinyl]-N-sulphamoylpropanamide S N
H
O
N
SN
H2NNH2
SNH2
O O
O
(D) 50 mg
MM 0029.51 2-[(Diaminomethylene)amino]-4-(4-cyanobutyl)thiazole Hydrochloride
N
SN
H2NNH2
N
x HCl
on request
Felodipine MM 0139.00 Felodipine H
N
O
O
Cl
O
OCl
(A) 100 mg
MM 0139.01 Imp. A (EP): Ethyl Methyl 4-(2,3-Dichlorophenyl)-2,6-dimethylpyridine-3,5-dicarboxylate
N
O
O
Cl
O
OCl
(D) 50 mg
MM 0139.02 Imp. B (EP): Dimethyl 4-(2,3-Dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate
HN
O
O
Cl
O
OCl
(A) 100 mg
MM 0139.03 Imp. C (EP): Diethyl 4-(2,3-Dichlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5-dicarboxylate
HN
O
O
Cl
O
OCl
(A) 100 mg
Pharmaceutical impurities
88 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Fenbendazole MM 2500.00 Imp. A (EP): Methyl (1H-Benzimidazol-2-yl)carbamate
(Carbendazim) N
HN
NHO
O (A) 100 mg
MM 0518.01 Fenbendazole Sulphoxide (Oxfendazole)
S N
HN
NHO
O
O
(A) 100 mg
MM 0518.02 Fenbendazole Sulphone
S N
HN
NHO
O
OO
(A) 100 mg
Fenbufen MM 0918.00 Fenbufen O
OH
O
(A) 500 mg
MM 0918.03 Imp. C (EP): Biphenyl (A) 100 mg
MM 0918.05 4-(4-Chlorophenyl)-4-oxobutanoic Acid (3-(4-Chlorobenzoyl)propionic Acid)
Cl
O
OH
O
(A) 100 mg
Fenfluramine Hydrochloride MM 0608.00 Fenfluramine Hydrochloride H
N
x HCl
FF
F
(A) 500 mg
MM 0608.01 Norfenfluramine Hydrochloride NH2
x HCl
FF
F
(A) 100 mg
MM 0608.02 N-Nitrosofenfluramine N
FF
F
NO (A) 100 mg
Fenofibrate MM 0505.00 Fenofibrate
Cl
O
OO
O (A) 500 mg
MM 0505.01 Imp. A (EP): (4-Chlorophenyl)(4-hydroxyphenyl)methanone Cl
O
OH (C) 100 mg
MM 0505.03 Imp. C (EP): (3RS)-3-[4-(4-Chlorobenzoyl)- phenoxy]butan-2-one Cl
O
O
O (A) 100 mg
MM 0505.04 Imp. D (EP): Methyl 2-[4-(4-Chlorobenzoyl)- phenoxy]-2-methylpropanoate Cl
O
OO
O (A) 100 mg
MM 0505.05 Imp. E (EP): Ethyl 2-[4-(4-Chlorobenzoyl)- phenoxy]-2-methylpropanoate Cl
O
OO
O (A) 100 mg
MM 0505.06 Imp. F (EP): (4-Chlorophenyl)[4-(1-methyl- ethoxy)phenyl]methanone
Cl
O
O (A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 89
Code Product Code Unit
New MM 0505.07 Imp. G (EP): 1-Methylethyl 2-[[2-[4- (4-Chlorobenzoyl)phenoxy]-2- methylpropanoyl]oxy]-2- methylpropanoate
Cl
O
OO
O
O
O
(A) 50 mg
Fenoprofen Calcium MM 0790.00 Fenoprofen Calcium Dihydrate
Ca 2+
x 2 H2OO O-
O2
(A) 500 mg
Fentanyl MM 0528.00 Fentanyl
[Controlled Substance] N
N
O
(A) 100 mg
MM 0528.09 Imp. A (EP) as Hydrochloride: N-Phenyl-N- [cis,trans-1-oxido-1-(2-phenylethyl)piperidin- 4-yl]propanamide Hydrochloride (Fentanyl N-Oxide Hydrochloride)
N
N
OO
x HCl
(A) 100 mg
MM 0528.08 Imp. B (EP): N-Phenyl-N-(piperidin-4-yl)propanamide NH
N
O (A) 100 mg
MM 0528.03 Imp. C (EP): N-phenyl-N-[1-(2-phenylethyl)- piperidin-4-yl]acetamide
N
N
O
(A) 100 mg
MM 0528.04 Imp. D (EP): N-phenyl-1-(2-phenylethyl)piperidin-4-amine N
HN
(A) 100 mg
MM 0093.17 Imp. F (EP) as Hydrochloride: Aniline Hydrochloride (Phenylamine Hydrochloride)
NH2x HCl
(B) 100 mg
MM 0528.07 Imp. G (EP): N-Phenylpropanamide NH
O (A) 100 mg
Fexofenadine Hydrochloride MM 0507.01 Imp. A (EP): 2-[4-[4-[4-(Hydroxydiphenyl-
methyl)piperidin-1-yl]butanoyl]phenyl]-2-methylpropanoic Acid (Ketofexofenadine)
ON
OH
O
OH
(A) 100 mg
MM 0507.03 Imp. C (EP): (1RS)-4-[4-(Hydroxydiphenyl- methyl)piperidin-1-yl]-1-[4-(1-methylethyl)- phenyl]butan-1-ol OH
N
OH
(A) 100 mg
MM 0055.02 Imp. E (EP): Diphenyl(piperidin-4-yl)methanol
NH
OH
(B) 100 mg
Pharmaceutical impurities
90 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Finasteride MM 0415.00 Finasteride
NH
O
O HN (A) 100 mg
MM 0415.01 Imp. A (EP): N-(1,1-Dimethylethyl)-3-oxo- 4-aza-5�-androstane-17�-carboxamide (Dihydrofinasteride)
NH
O
O HN
H
(A) 100 mg
MM 0415.02 Imp. B (EP): Methyl 3-Oxo-4-aza-5�-androst- 1-ene-17�-carboxylate (�-1-Aza Ester)
NH
O
OO
H
(A) 100 mg
Flavoxate Hydrochloride MM 0156.00 Flavoxate Hydrochloride
O
OON
O
x HCl
(A) 100 mg
MM 0156.01 Imp. A (EP): 3-Methyl-4-oxo-2-phenyl-4H-1- benzopyran-8-carboxylic Acid (3-Methyl- flavone-8-carboxylic Acid)
O
OHO
O (A) 100 mg
MM 0156.02 Imp. B (EP): Ethyl 3-Methyl-4-oxo-2-phenyl- 4H-1-benzopyran-8-carboxylate (3-Methyl- flavone-8-carboxylic Acid Ethyl Ester)
O
OO
O (A) 100 mg
MM 0156.05 Imp. C (EP): 1-Methylethyl-3-Methyl-4-oxo- 2-phenyl-4H-1-benzopyran-8-carboxylate (3-Methylflavone-8-carboxylic Acid Isopropyl Ester)
O
OO
O (A) 50 mg
Flecainide Acetate MM 0488.04 Imp. D (EP): 2,5-Bis(2,2,2-trifluoroethoxy)benzoic Acid
O
O
OH
O
F
F F
F
F F
(A) 100 mg
MM 0488.02 Imp. B (EP): (RS)-(Piperidin-2-yl)methanamine H2N
HN(A) 100 mg
Fluanisone MM 1247.02 1-(2-Methoxyphenyl)piperazine Dihydrochloride
HN
N
O
x 2 HCl
(A) 100 mg
Flubendazole MM 0463.00 Flubendazole
O
N
HNF
NHO
O (A) 100 mg
MM 0463.02 Imp. B (EP): (2-Amino-1H-benzimidazol-5-yl)(4-fluorophenyl)methanone
O
N
HNF
NH2
(A) 100 mg
MM 0463.03 Imp. C (EP): (4-Fluorophenyl)(2-hydroxy-1H-benzimidazol-5-yl)methanone
O
N
HNF
OH
(C) 50 mg
MM 0463.04 Imp. D (EP): (1H-Benzimidazol-5-yl)(4-fluorophenyl)methanone
O
N
HNF on request
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 91
Code Product Code Unit
MM 0463.05 Imp. E (EP): Methyl [5-(2-Fluorobenzoyl)-1H-benzimidazol-2-yl]carbamate
O
N
HN
NHO
O
F
(C) 50 mg
MM 0463.06 Imp. F (EP): Methyl [5-(4-Fluorobenzoyl)-1-methyl-1H-benzimidazol-2-yl]carbamate
O
N
NFNH
OO (C) 50 mg
MM 0463.07 Imp. G (EP): Methyl [5-[4-(1-Methylethoxy)benzoyl]-1H-benzimidazol-2-yl]carbamate
O
N
HNO
NHO
O (D) 100 mg
Flucloxacillin Sodium MM 0489.00 Flucloxacillin Sodium Hydrate
N
SH
O
OONa
HN
NO
F
Cl
O
x H2O
(A) 500 mg
MM 0489.01 Imp. A (EP) as Disodium Salt: (4S)-2-[Carboxy[[[3-(2-chloro-6-fluorophenyl)-5-methylisoxazol-4-yl]carbonyl]amino]methyl]-5,5-dimethylthiazolidine-4-carboxylic Acid Disodium Salt (Penicilloic Acids of Flucloxacillin Disodium Salt)
HN
S
OONa
HN
NO
F
Cl
OO ONa
(A) 100 mg
MM 0489.02 Imp. B (EP): (2RS,4S)-2-[[[[3-(2-Chloro-6-fluorophenyl)-5-methylisoxazol-4-yl]-carbonyl]amino]methyl]-5,5-dimethyl-thiazolidine-4-carboxylic Acid (Penilloic Acids of Flucloxacillin) HN
S
OOH
NHN
OF
Cl
O
(A) 50 mg
MM 0026.04 Imp. C (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid (6-Aminopenicillanic Acid)
N
SH
O
H2N
OOH (B) 100 mg
MM 0489.03 Imp. D (EP): 3-(2-Chloro-6-fluorophenyl)-5-methylisoxazole-4-carboxylic Acid
OHN
OF
Cl
O
(C) 100 mg
Fluconazole MM 0235.00 Fluconazole
N
N
NN
N
N
HOF
F (A) 100 mg
MM 0235.11 Imp. A (EP): (2RS)-2-(2,4-Difluorophenyl)-1-(1H-1,2,4-triazol-1-yl)-3-(4H-1,2,4-triazol-4-yl)propan-2-ol
N
N
N N
N
N
HOF
F (A) 100 mg
MM 0235.12 Imp. B (EP): 2-[2-Fluoro-4-(1H-1,2,4-triazol-1- yl)phenyl]-1,3-bis(1H-1,2,4-triazol-1-yl)propan-2-ol
N
N
NN
N
N
HOF
NNN (D) 100 mg
MM 0235.13 Imp. C (EP): 1,1'-(1,3-Phenylene)di-1H-1,2,4-triazole N
NN
N
NN (A) 50 mg
MM 0235.14 Imp. D (EP): 2-(4-Fluorophenyl)-1,3-bis(1H- 1,2,4-triazol-1-yl)propan-2-ol
N
N
NN
N
N
HO
F (A) 100 mg
Pharmaceutical impurities
92 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0235.02 Imp. F (EP): (2RS)-2-(2,4-Difluorophenyl)-3-(1H-1,2,4-triazol-1-yl)propane-1,2-diol
OH
N
N
N
HOF
F (A) 50 mg
MM 0235.01 2-(2,4-Difluorophenyl)propane-1,2,3-triol
OH
HOHOF
F (A) 100 mg
MM 0235.03 1H-1,2,4-Triazol HN
NN
(B) 100 mg
MM 0235.04 2-Chloro-2',4'-difluoroacetophenone F
F
OCl
(C) 100 mg
MM 0235.06 1-(2,4-Difluorophenyl)-2-(1H-1,2,4-triazol-1-yl)ethanol F
F
HON
N
N
(A) 100 mg
MM 0235.09 4-Amino-1,2,4-triazole NH2
N
NN
(C) 100 mg
Flucytosine MM 0593.00 Imp. A (Pharmeuropa): Fluorouracil
NH
O
HN
O
F(A) 500 mg
Flufenamic Acid MM 0410.00 Flufenamic Acid O
OH
NH
F
F F
(A) 500 mg
Flumetasone Pivalate MM 0427.01 Imp. A (EP): 6�,9-Difluoro-11�,17,21-trihydroxy-16�-
methylpregna-1,4-diene-3,20-dione (Flumetasone)
O
HO
F
F
OH
O
OH(A) 100 mg
Flunarizine Dihydrochloride MM 0175.00 Flunarizine Dihydrochloride
N
N
F
F
x 2 HCl
(A) 500 mg
MM 0175.04 Imp. A (EP): 1-[Bis(4-fluorophenyl)methyl]piperazine N
F
FNH (A) 100 mg
MM 0175.03 Imp. C (EP) as Dihydrochloride: 1-[(RS)-(2-Fluorophenyl)(4-fluoro- phenyl)methyl]-4-[(2E)-3-phenylprop- 2-enyl]piperazine Dihydrochloride
N
NF
Fx 2 HCl
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 93
Code Product Code Unit
MM 0175.02 Chlorobis-(4-fluorophenyl)methane Cl
FF
(B) 100 mg
MM 0175.05 1-Bis(4-fluorophenyl)methyl-4-(ethoxycarbonyl)piperazine
N
FF
N
O O (B) 10 mg
MM 0175.06 Flunarizine N-Oxide Dihydrochloride
NN
F
F
x 2 HCl
O (A) 100 mg
Flunitrazepam MM 0069.00 Flunitrazepam
[Controlled Substance] N
NO
O2N
F
on request
MM 0069.02 Imp. B (EP): 5-(2-Fluorophenyl)-7-nitro-1,3-dihydro-2H-1,4-benzodiazepin-2-one (Demethylflunitrazepam)
N
HN
O
O2N
F
(A) 100 mg
Flunixin Meglumine MM 0915.00 Flunixin Meglumine
N
OH
O
NH
F
HO
OHHN
HO
OHOH
x
FF (A) 100 mg
MM 0915.01 Imp. A (EP): 2-Chloropyridine-3-carboxylic Acid N
OH
O
Cl (A) 100 mg
MM 0915.03 Imp. C (EP): Ethyl 2-Chloropyridine-3-carboxylate N
O
O
Cl (A) 100 mg
Fluorescein Sodium MM 0294.01 Imp. A (EP): Resorcinol
HO OH
(B) 100 mg
MM 0133.04 Imp. C (EP): 2-(2,4-Dihydroxybenzoyl)benzoic Acid
HO OH
O
OH
O
(A) 100 mg
Fluorouracil MM 0593.00 Fluorouracil
NH
O
HN
OF
(A) 500 mg
MM 0265.03 Imp. A (EP): Pyrimidine-2,4,6-(1H,3H,5H)-trione (Barbituric Acid)
NH
O
HN
O
O
(C) 100 mg
MM 0593.01 Imp. B (EP): Dihydropyrimidine-2,4,5(3H)-trione (Isobarbituric Acid or 5-Hydroxyuracil)
NH
O
HN
O
O(A) 100 mg
Pharmaceutical impurities
94 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0593.03 Imp. C (EP): Pyrimidine-2,4(1H,3H)-dione (Uracil)
NH
O
HN
O (C) 100 mg
MM 0593.05 Imp. E (EP): 5-Chloropyrimidine-2,4(1H,3H)dione (5-Chlorouracil)
NH
O
HN
O
Cl(A) 100 mg
MM 0593.06 Imp. F (EP): 2-Ethoxy-5-fluoropyrimidin- 4(1H)-one (2-Ethoxy-5-fluorouracil)
NH
O
N
O
F(A) 100 mg
Fluoxetine Hydrochloride MM 0256.00 Fluoxetine Hydrochloride O
HN
x HClF
F F
(A) 50 mg
MM 0256.01 Imp. A (EP): (1RS)-3-(Methylamino)-1-phenylpropan-1-ol HOHN (A) 100 mg
MM 0256.02 Imp. B (EP) as Hydrochloride: N-Methyl-3- phenylpropan-1-amine Hydrochloride (Methyl-3-phenylpropylamine Hydrochloride) [Controlled Substance]
x HCl
HN (A) 100 mg
MM 0256.03 Imp. C (EP) as Hydrochloride:(3RS)-N-Methyl-3-phenyl-3-[3-(trifluoromethyl]phenoxy]propan-1-amine Hydrochloride
OHN
x HCl
FF
F
(A) 100 mg
MM 0256.05 4-Hydroxybenzotrifluoride OH
F
F F
(B) 100 mg
MM 0256.06 4-Chlorobenzotrifluoride Cl
F
F F
(B) 100 mg
MM 0256.10 3-Dimethylamino-1-phenylpropan-1-ol OH
N(A) 100 mg
MM 0256.16 N-Formylfluoxetine O N
F
O
F F
(A) 100 mg
New MM 256.17 (3RS)-N-Methyl-3-phenyl-3-[2-(trifluoromethyl)-phenoxy]propan-1-amine Hydrochloride (2-Trifluoromethylisomer of Fluoxetine Hydro-chloride)
OHN
x HCl
F FF
(A) 100 mg
Fluoxymesterone MM 0959.00 Fluoxymesterone
HOOH
FO
(A) 100 mg
Flupentixol Decanoate MM 0182.00 Flupentixol Decanoate
S
CF3
NN
O
O
on request
MM 0182.08 Imp. B (BP): 2-Trifluoromethylthioxanthone
S
CF3
O (A) 100 mg
MM 0182.05 1-(2-Hydroxyethyl)piperazine HNN
OH (B) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 95
Code Product Code Unit
MM 0182.06 cis/trans-3-[2-(Trifluoromethyl)-9H-thioxanthen-9-ylidene]propene
S
CF3
on request
MM 0182.07 4-Chloro-3-nitrobenzotrifluoride CF3O2N
Cl
(B) 100 mg
MM 0182.09 4-Fluoro-3-nitrobenzotrifluoride F
CF3O2N (B) 100 mg
Flupentixol Dihydrochloride MM 0182.08 Imp. G (EP): 2-(Trifluoromethyl)-9H-thioxanthen-9-one
(2-Trifluoromethylthioxanthone) S
CF3
O (A) 100 mg
MM 0182.05 1-(2-Hydroxyethyl)piperazine HNN
OH (B) 100 mg
MM 0182.06 cis/trans-3-[2-(Trifluoromethyl)-9H-thioxanthen-9-ylidene]propene
S
CF3
on request
MM 0182.07 4-Chloro-3-nitrobenzotrifluoride CF3O2N
Cl
(B) 100 mg
Fluphenazine Dihydrochloride MM 0114.00 Fluphenazine Dihydrochloride
S
N N
NOH
F
F F
x 2 HCl
(A) 500 mg
MM 0114.01 Imp. A (EP): 2-[4-[3-[5-Oxo-2-(trifluoromethyl)- 10H-54-phenothiazin-10-yl]propyl]piperazin-1- yl]ethanol (Fluphenazine S-Oxide) S
N N
NOH
F
F F
O
(A) 100 mg
MM 0114.07 Imp. D (EP): 10,10'-[Piperazine-1,4-diylbis(propane-3,1-diyl)] bis[2-(trifluoromethyl)-10H-phenothiazine]
N
NN
N
S
S
F
F F
F
F F (A) 100 mg
MM0826.00 Imp. E (Pharmeuropa): 2-[4-[3-[2-Chloro-10H-phenothiazin-10-yl]propyl]piperazin-1-yl]ethanol (Perphenazine) S
N N
NOH
Cl
(A) 100 mg
MM 0114.04 Fluphenazine N,N',S-Trioxide Dihydrochloride
SN N
NOH
F
x 2 HCl
O
OO
F F
on request
Flurazepam Monohydrochloride MM 0070.01 Imp. A (EP): [5-Chloro-2-[[2-(diethylamino)ethyl]amino]phenyl]-
(2-fluorophenyl)methanone Cl
HN
O
F
Non request
MM 0070.02 Imp. B (EP): 7-Chloro-5-(2-fluorophenyl)-1,3-dihydro-2H-1,4- benzodiazepin-2-one
N
HN
O
Cl
F
(A) 100 mg
Pharmaceutical impurities
96 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0070.03 2-Chloro-10-(2-diethylaminoethyl)-9,10-dihydroacridin-9-one
Cl
N
O
N (A) 100 mg
MM 0070.06 Flurazepam [Controlled Substance]
N
NO
Cl
F
N (A) 100 mg
Flurbiprofen MM 0727.01 Imp. A (EP): (2RS)-2-(Biphenyl-4-yl)propanoic
AcidOH
O
(A) 50 mg
New MM 0727.03 Imp. C (EP): (2RS)-2-(2-Fluorobiphenyl-4-yl)- 2-hydroxypropanoic Acid F OH
O
HO (A) 50 mg
Flutamide MM 0161.00 Flutamide
NO2
HN
OF
FF (A) 500 mg
MM 0161.03 Imp. A (EP): 4-Nitro-3-(trifluoromethyl)aniline
NO2
H2NF
F F (A) 100 mg
MM 0161.04 Imp. B (EP): N-[4-Nitro-3-(trifluoromethyl)phenyl]acetamide
NO2
HN
O
F
F F (A) 100 mg
MM 0161.05 Imp. C (EP): N-[4-Nitro-3-(trifluoromethyl)phenyl]propanamide
NO2
HN
O
F
F F (A) 100 mg
MM 0161.06 Imp. D (EP): 3-(Trifluoromethyl)aniline H2N
F
F F (B) 100 mg
MM 0161.07 Imp. E (EP): 2-Methyl-N-[3-(trifluoromethyl)phenyl]propanamide HN
O
F
F F (A) 100 mg
MM 0161.08 Imp. F (EP): 2-Methyl-N-[2-nitro-5-(trifluoromethyl)phenyl]propanamide
O2N
HN
O
F
F F (D) 100 mg
MM 0161.01 2-Hydroxy-2-methyl-N-[4-nitro-3-(trifluoromethyl)-phenyl]propanamide (2-Hydroxyflutamide)
NO2
HN
OF
F FHO (A) 100 mg
MM 0161.09 Trifluoromethylbenzene F
F F (B) 100 mg
MM 0161.10 3-Nitrobenzotrifluoride O2N
F
F F (B) 100 mg
MM 0161.12 3-Trifluoromethyl-4-nitrophenol
NO2
HOF
F F (A) 100 mg
Fluticasone Propionate New MM 1244.10 6alpha,9alpha-Difluoro-11beta,17alpha-dihydroxy-16alpha-
methyl-3-oxoandrosta-1,4-diene-17beta-carboxylic Acid
O
HO
F
OH
OOH
F
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 97
Code Product Code Unit
Fluvastatin Sodium MM 0676.00 Fluvastatin Sodium
N
F
OHOH
O
ONa
(D) 100 mg
Folic Acid MM 0621.00 Folic Acid
NH
NH
O
OH
O
O OH
N
N
N
NH
O
H2N
(A) 500 mg
MM 0621.01 Imp. A (EP): (2S)-2-[(4-Aminobenzoyl)amino]pentanedioic Acid (N-(4-Aminobenzoyl)-L-glutamic Acid)
H2N
NH
O
OH
O
O OH (A) 100 mg
MM 0621.02 Imp. B (EP) as Sulphate: 2,5,6-Triaminopyrimidin-4(1H)-one Sulphate N
NH
H2N
ONH2
NH2
x H2SO4
(A) 100 mg
MM 0621.04 Imp. D (EP): 4-[[(2-Amino-4-oxo-1,4-dihydropteridin-6-yl)methyl]amino]benzoic Acid (Pteroic Acid)
N
NH
H2N
ON
N
NH
OH
O (D) 50 mg
MM 0094.03 4-Aminobenzoic Acid
H2N
OH
O (B) 100 mg
MM 0169.00 L-Glutamine OH
NH2
O
H2N
O
(A) 500 mg
Formoterol Fumarate Dihydrate MM 0447.00 Formoterol Fumarate Dihydrate
HO
HN
OHHN
OO
O
HOOH
O
x x 2 H2O
and enantiomer 2
(D) 50 mg
Furosemide MM 0014.00 Furosemide O OH
S
Cl
HN
OH2N
O O
(A) 500 mg
MM 0014.02 Imp. A (EP): 2-Chloro-4-[(furan-2-ylmethyl)amino]-5-sulphamoylbenzoic Acid
O OH
S
Cl
HNO
H2N
O O
(A) 100 mg
MM 0014.03 Imp. B (EP): 2,4-Dichloro-5-sulphamoylbenzoic Acid O OH
S
Cl
Cl
H2N
O O
(B) 100 mg
MM 0014.01 Imp. C (EP): 2-Amino-4-chloro-5-sulphamoylbenzoic Acid O OH
S
Cl
NH2
H2N
O O
(A) 100 mg
Pharmaceutical impurities
98 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0014.04 Imp. D (EP): 2,4-Bis[(furan-2-ylmethyl)amino]- 5-sulphamoylbenzoic Acid
O OH
S
HN
O
OHN
H2N
O O
(D) 100 mg
MM 0014.05 Imp. E (EP): 2,4-Dichlorobenzoic Acid O OH
Cl
Cl
(B) 100 mg
MM 0014.50 Ethyl 2,4-Dichloro-5-sulphamoylbenzoate O O
S
Cl
Cl
H2N
O O
(A) 100 mg
Gabapentin MM 0684.01 Imp. A (Pharmeuropa): 2-Azaspiro[4.5]decan-
3-one (3,3-Pentamethylene-4-butyrolactam) HN
O (A) 100 mg
MM 0684.07 Imp. E (Pharmeuropa): 1-(Carboxymethyl)cyclo- hexanecarboxylic Acid
HOO
OH
O (A) 100 mg
Ganciclovir MM 0061.02 Imp. F (EP): 2-Amino-1,9-dihydro-6H-purin-6-one (Guanine)
HN
N
O
H2N NH
N(B) 100 mg
MM 0485.09 Imp. I (EP): 2-[(2-Amino-6-oxo-1,6-dihydro- 9H-purin-9-yl)methoxy]-propane-1,3-diyl Dipropanoate (Ganciclovir Dipropionate)
HN
N
O
H2N N
N
O
O
OO
O
(A) 100 mg
MM 0485.10 Imp. J (EP): 2-[2-(Propanoylamino)-6-oxo- 1,6-dihydro-9H-purin-9-yl]methoxy] propane-1,3-diyl dipropanoate (Ganciclovir Tripropionate)
HN
N
O
NH
N
N
O
O
OO
O
O
(A) 100 mg
Gemcitabine Hydrochloride MM 0749.05 Imp. A (EP): 4-Aminopyrimidin-2(1H)-one
(Cytosine) N
NH
NH2
O
(A) 100 mg
Gemfibrozil MM 0641.00 Gemfibrozil O OH
O
(A) 250 mg
MM 0641.08 Imp. A (EP): 2,5-Dimethylphenol (p-Xylenol) OH (A) 100 mg
MM 0641.07 Imp. E (EP): 5-[2,5-Dimethyl-4-(prop-1-enyl)- phenoxy]-2,2-dimethylpentanoic Acid
O OH
O
(D) 100 mg
MM 0641.02 Imp. H (EP): 1,3-Bis(2,5-dimethylphenoxy)propane OO (A) 100 mg
MM 0641.01 3-(2,5-Dimethylphenoxy)propyl Chloride (3-(2,5-Xylyloxy)propyl Chloride)
O Cl (A) 100 mg
MM 0641.03 Gemfibrozil Isobutyl Ester O O
O
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 99
Code Product Code Unit
Gestodene MM 0124.06 Imp. L (EP): 13-Ethyl-17-hydroxy-18,19-
dinor-17�-pregna-5,15-dien-20-yn-3-one (���6)-Gestodene)
OH
O
(A) 100 mg
Glibenclamide MM 0008.00 Glibenclamide
SNH
NH
OO O
NH
O
O
Cl
(A) 500 mg
MM 0008.01 Imp. A (EP): 5-Chloro-2-methoxy-N-(2-(4-sulfamoylphenyl)ethyl)benzamide
SNH2
O O
NH
O
O
Cl
(A) 100 mg
MM 0008.02 Imp. B (EP): Methyl [[4-[2-[(5-Chloro-2-methoxybenzoyl)amino]ethyl]phenyl]-sulphonyl]carbamate
SNH
O
OO O
NH
O
O
Cl
(A) 100 mg
New MM 0942.09 Imp. C (Pharmeuropa): 1-[[4-[2- [(Cyclohexylcarbamoyl)amino]ethyl] phenyl]sulfonyl]-3-cyclohexylurea (N-(Cyclohexylcarbamoyl)-4-[2- [(cyclohexylcarbamoyl)amino]ethyl] benzene-Sulphonamide)
NH
NH
OS
NH
O O
NH
O (A) 100 mg
MM 0008.03 5-Chloro-2-methoxybenzoic Acid OH
O
O
Cl(B) 100 mg
MM 0008.04 5-Chloro-N-(2-phenylethyl)-2-methoxybenzamide NH
O
O
Cl(A) 100 mg
Gliclazide MM 0325.00 Gliclazide
NH
SO O
NH
ON
(A) 500 mg
MM 0325.01 Imp. A (EP): 4-Methylbenzenesulphonamide NH2
SO O (C) 100 mg
MM 0325.02 Imp. B (EP): 2-Nitroso-octahydrocyclopenta[c]pyrrole
NN
O
(A) 100 mg
MM 0325.03 Imp. C (EP): Ethyl [(4-Methylphenyl)sulphonyl]- Carbamate N
HS
O
OOO (A) 100 mg
MM 0325.06 Imp. F (EP): 1-(Hexahydrocyclopenta[c]pyrrol- 2(1H)-yl)-3-[(2-methylphenyl)sulphonyl]urea
NH
SNH
O
NO O
(A) 100 mg
MM 0325.09 Methyl N-Methyl-p-tolylsulphoncarbamate N
SO
OO O (A) 100 mg
Glimepiride MM 0647.00 Glimepiride
NO
NH
O
SNH
O O
NH
O (D) 100 mg
MM 0647.02 Imp. A (EP): 1-[[4-[2-[[(3-Ethyl-4-methyl-2-oxo-2,3-dihydro-1H-pyrrol-1-yl)carbonyl]-amino]ethyl]phenyl]sulphonyl]-3-(cis-4-methylcyclohexyl)urea (cis-Glimepiride) NO
NH
O
SNH
NH
OO O (D) 100 mg
Pharmaceutical impurities
100 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0647.01 Imp. B (EP): 3-Ethyl-4-methyl-2-oxo-N-[2-(4-sulphamoylphenyl)ethyl]-2,3-dihydro-1H-pyrrole-1-carboxamide (Glimepiride Sulphonamide)
SNH2
O O
NH
N
O
O
(A) 100 mg
MM 0647.03 Imp. C (EP): Methyl [[4-[2-[[(3-Ethyl-4-methyl-2-oxo-2,3-dihydro-1H-pyrrol-1-yl) carbonyl]amino]ethyl]phenyl]- sulphonyl]carbamate (Glimepiride Carbamate)
SNH
O O
NH
N
O
O
O
O (A) 100 mg
MM 0647.04 Imp. D (EP): 1-[[3-[2-[[(3-Ethyl-4-methyl-2-oxo- 2,3-dihydro-1H-pyrrol-1-yl)carbonyl]amino]ethyl]-phenyl]sulphonyl]-3-(trans-4-methylcyclohexyl)-urea
SNH
NH
OO O
HN
O
N
O
(D) 100 mg
MM 0647.08 cis-4-Methylcyclohexylamine Hydrochloride H2N
x HCl(A) 100 mg
Glipizide MM 0942.01 Imp. A (EP): 5-Methyl-N-[2-(4-sulphamoyl-
phenyl)ethyl]pyrazine-2-carboxamide
N
NNH
OS
NH2
O O (A) 100 mg
MM 0678.03 Imp. B (EP): Cyclohexanamine H2N
(C) 100 mg
MM 0942.04 Imp. D (EP): 6-Methyl-N-[2-(4-sulphamoylphenyl)ethyl]pyrazine-2-carboxamide
N
NNH
OS
NH2
O O (A) 100 mg
MM 0942.05 Imp. E (EP): 1-Cyclohexyl-3-[[4-[2-[[(6-methyl-pyrazin-2-yl)carbonyl]amino]ethyl]phenyl]- sulphonyl]urea
N
NNH
OS
NH
O O
NH
O (A) 100 mg
MM 0942.06 Imp. F (EP): Ethyl [2-(4-Sulphamoylphenyl)- ethyl]carbamate
O NH
OS
NH2
O O (A) 100 mg
MM 0942.07 Imp. G (EP): Methyl [[4-[2-[[(5-Methylpyrazin- 2-yl)carbonyl]amino]ethyl]phenyl] sulphonyl]Carbamate
N
NNH
OS
NH
O O
O
O (A) 100 mg
MM 0942.08 Imp. H (EP): 4-[2-[(Cyclohexylcarbamoyl)amino]- ethyl]benzenesulphonamide
NH
NH
OS
NH2
O O (A) 100 mg
MM 0942.09 Imp. I (EP): N-(Cyclohexylcarbamoyl)- 4-[2-[(cyclohexylcarbamoyl)amino] ethyl]benzenesulphonamide
NH
NH
OS
NH
O O
NH
O (A) 100 mg
Glutamine MM 0169.00 L-Glutamine
OHNH2
O
H2N
O
(A) 500 mg
MM 0169.01 N-Phenylacetyl-L-glutamine (Phenylacetylglutamine)
OHHN
O
O
H2N
O
(A) 100 mg
MM 0169.02 Phenylacetamide NH2
O
(A) 100 mg
MM 0169.03 D-Glutamine OH
NH2
O
H2N
O
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 101
Code Product Code Unit
Glycopyrronium Bromide MM 0834.00 Glycopyrronium Bromide
O
O
Br-
OH
N+
and enantiomer
(A) 100 mg
MM 0834.05 Imp. B (Pharmeuropa): Oxophenylacetic Acid (Benzoylformic Acid)
O
O
OH
(A) 100 mg
MM 0792.03 Imp. C (Pharmeuropa): (2RS)-Hydroxyphenyl- acetic Acid (Mandelic Acid)
OH
O
OH
(A) 100 mg
MM 0278.01 Imp. D (Pharmeuropa): Benzoic Acid
O
OH(B) 100 mg
MM 0834.07 Imp. H (Pharmeuropa): Methyl Oxophenylacetate (Methyl Benzoylformate)
O
O
O
(A) 100 mg
MM 0834.01 Imp. J (Pharmeuropa): 2-(RS)-Cyclopentylhydroxy- phenylacetic Acid ��-Cyclopentylmandelic Acid) OH
O
OH
(A) 100 mg
MM 0834.08 Imp. K (Pharmeuropa): 2-(RS)-Cyclopentylphenyl- acetic Acid OH
O (A) 100 mg
MM 0834.06 Imp. M (Pharmeuropa): Cyclopentylphenylmethanone O
(A) 100 mg
Granisetron Hydrochloride MM 0398.00 Granisetron Hydrochloride
NHN
H
H
x HCl
O
NN
on request
Griseofulvin MM 0582.00 Griseofulvin
OO
O
O
ClO
O
(A) 500 mg
Guaiacol MM 0354.04 Guaiacol OH
O
(A) 500 mg
MM 0814.04 Imp. A (EP): Benzene-1,2-diol (Pyrocatechol) OH
OH
(C) 100 mg
MM 0045.11 Imp. B (EP): Phenol OH (B) 100 mg
MM 0814.06 Imp. C (EP): 1,2-Dimethoxybenzene (Veratrole) O
O
(C) 100 mg
MM 0814.08 Imp. E (EP): Methyl Benzoate O
O (C) 100 mg
MM 1131.00 Imp. G (EP): 4-Methoxyphenol (Mequinol) OH
O
(A) 500 mg
MM 0007.09 Imp. H (EP): 3-Methoxyphenol OH
O
(B) 100 mg
2297/SR/0909
From Atorvastatin to Zopiclone -2�00 pharmaceutical impurities LGC Standards offers 2�00 reference standards for
pharmaceutical impurities to support the pharmaceutical
industry worldwide.
• Acknowledged by regulation authorities worldwide
• Impurities linked to the European Pharmacopoeia (EP) wherever possible
• Customised pharmaceutical impurities created on request
• Detailed certificates of analysis provided
• Additional documentation on request
• Assistance in finding the right material to suit your analyses
www.lgcstandards.com
© LGC Limited, 2009. All rights reserved.
• Atorvastatin
• Bupropion
• Clopidogrel
• Esomeprazol
• Ibuprofen
• Naproxen
• Omeprazole
• Risperidone
• Sildenafil
• Steroid hormones
• Venlafaxine
• Zopiclone
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 103
Code Product Code Unit
Guaifenesin MM 0354.00 Guaifenesin
O
OOH
OH(A) 500 mg
MM 0354.04 Imp. A (EP): 2-Methoxyphenol (Guaiacol)
O
OH (A) 500 mg
MM 0354.01 Imp. B (EP): 2-(2-Methoxyphenoxy)propane-1,3-diol (B-Isomer)
O
OOHHO (A) 100 mg
MM 0354.02 Imp. C (EP): 1,1'-Oxybis[3-(2-methoxyphenoxy) propan-2-ol](Bisether)
O
OOH
OOH
O
O
(A) 100 mg
MM 0354.03 Imp. D (EP): 1,3-Bis(2-methoxyphenoxy)propan-2-ol
O
O
OH
O
O
(A) 100 mg
Halofantrine Hydrochloride MM 0433.00 Halofantrine Hydrochloride
x HCl
F F
F
Cl
Cl
NHO
(A) 100 mg
Haloperidol MM 1165.00 Haloperidol F
O
N
OH
Cl(A) 250 mg
Haloperidol Decanoate MM 1276.12 Imp. L (EP): 1-(4-Fluorophenyl)ethanone F
O
(A) 100 mg
Harpagoside MM 0370.01 Methyl trans-Cinnamate
O
O (B) 100 mg
Heptaminol Hydrochloride MM 0653.00 Heptaminol Hydrochloride NH2
HOx HCl on request
Hexetidine MM 0337.03 Imp. C (EP): 2,6-Bis(2-ethylhexyl)-7a-
methylhexahydro-1H-imidazo[1,5-c]imidazole (Hexedine)
N
NN
(A) 100 mg
Hexylresorcinol MM 0111.00 Hexylresorcinol HO OH (A) 500 mg
MM 0045.11 Imp. A (EP): Phenol OH (B) 100 mg
MM 0294.01 Imp. B (EP): Resorcinol HO OH (B) 100 mg
Homatropine Methylbromide MM 0792.00 Homatropine Methylbromide
O
OH
ON+
H
H
HBr-
and enantiomer
(A) 250 mg
Pharmaceutical impurities
104 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0792.03 Imp. C (EP): (2RS)-2-Hydroxy-2-phenylacetic Acid (Mandelic Acid) OH
OH
O (A) 100 mg
MM 0792.04 Imp. D (EP) as Bromide: (1R,2R,4S,5S,7s)-7-[[(2S)-3-Hydroxy-2-phenylpropanoyl]oxy]-9,9-dimethyl-3-oxa-9-azoniatricyclo[3.3.1.02,4]nonane Bromide (Methylhyoscine Bromide)
O
O
OH
N+ O
H
H
H
H
H
Br-
(A) 100 mg
MM 0792.06 Imp. F (EP): Methyl (2RS)-2-Hydroxy-2-phenylacetate (Methyl Mandelate) O
OH
O (A) 100 mg
Hydrochlorothiazide MM 0011.00 Hydrochlorothiazide
NH
NHS
O OS
Cl
H2N
O O (A) 500 mg
MM 0011.03 Imp. A (EP): Chlorothiazide
N
NHS
O OS
Cl
H2N
O O (A) 500 mg
MM 0011.01 Imp. B (EP): 4-Amino-6-chlorobenzene-1,3-disulphonamide (Salamide)
NH2
NH2S
O OS
Cl
H2N
O O (B) 100 mg
Hydrocodone Hydrogen Tartrate 2.5-Hydrate MM 0037.00 Imp. A (EP) as Hydrochloride Trihydrate: Morphine
Hydrochloride Trihydrate [Controlled Substance]
O OHHO
N
x HClx 3 H2O
(A) 250 mg
MM 0280.00 Imp. A (EP) as Hemisulphate Pentahemihydrate: Morphine Hemisulphate Pentahemihydrate [Controlled Substance]
O OHHO
N
2
x H2SO4x 5 H2O
(A) 250 mg
MM 0004.00 Imp. C (EP) as Monohydrate: Codeine Monohydrate [Controlled Substance]
O OHO
N
x H2O
(A) 100 mg
MM 0442.00 Imp. C (EP) as Phosphate Hemihydrate: Codeine Phosphate Hemihydrate [Controlled Substance]
O OHO
N
x H3PO4x 1/2 H2O
(A) 100 mg
MM 0672.00 Imp. D (EP) as Hydrochloride: 4,5�-Epoxy-14- hydroxy-3-methoxy-17-methyl-morphinan-6- one Hydrochloride (Oxycodone Hydrochloride) [Controlled Substance]
O OO
N
HO x HCl
(A) 100 mg
MM 0004.02 Imp. E (EP): 7,8-Didehydro-4,5�-epoxy-3-methoxy-17-methylmorphinan-6-one (Codeinone)
O OO
N (A) 100 mg
MM 0004.03 Imp. F (EP): 7,8-Didehydro-4,5�-epoxy-3,6�-dimethoxy-17-methylmorphinan (Methylcodeine; O-Methylcodeine) [Controlled Substance]
O OO
N (A) 100 mg
MM 0630.01 Imp. H (EP): Diphenylmethanone (Benzophenone) O (B) 100 mg
Hydrocortisone MM 0185.00 Hydrocortisone
O
HO OH
OOH
(A) 500 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 105
Code Product Code Unit
MM 0193.00 Imp. A (EP): Prednisolone
O
HO OH
OOH
(A) 500 mg
MM 0214.00 Imp. B (EP): 17,21-Dihydroxypregn-4-ene- 3,11,20-trione (Cortisone)
O
O OH
OOH
(A) 500 mg
MM 0187.00 Imp. C (EP): Hydrocortisone Acetate (Hydrocortisone 21-Acetate)
O
HO OH
OO
O (A) 500 mg
MM 0185.06 Imp. D (EP): 6�,11�,17,21-Tetrahydroxy-pregn-4-ene-3,20-dione (6�-Hydroxyhydrocortisone)
O
HO OH
OOH
OH
(A) 100 mg
MM 0185.07 Imp. E (EP): 11�,17,21-Trihydroxypregna-4,6-diene-3,20-dione (��-Hydrocortisone)
O
HO OH
OOH
(D) 100 mg
MM 0185.08 Imp. F (EP): 17,21-Dihydroxypregn-4-ene-3,20-dione (Reichstein's Substance S)
O
OH
OOH
(A) 100 mg
MM 0185.13 6�-Hydroxyhydrocortisone
O
HO OH
OOH
OH
(D) 50 mg
Hydrocortisone Acetate MM 0187.00 Hydrocortisone Acetate
O
HO OH
OO
O (A) 500 mg
MM 0185.00 Imp. A (Pharmeuropa): 11�,17,21-Trihydroxy- pregn-4-ene-3,20-dione (Hydrocortisone)
O
HO
O
OHOH
(A) 500 mg
MM 0185.00 Imp. A (Pharmeuropa): 11�,17,21-Trihydroxy- pregn-4-ene-3,20-dione (Hydrocortisone)
O
HO
O
OHOH
(A) 500 mg
MM 0187.06 Hydrocortisone 11,17,21-Triacetate
O
O
OO
O
O
OO
(B) 10 mg
MM 0187.09 11�,17,21-Trihydroxypregna-4,6-diene-3,20-dione 21-Acetate
O
HO
OO
OH
O (D) 100 mg
MM 0194.00 Imp. C (Pharmeuropa): 11�,17-Dihydroxy-3,20- dioxopregna-1,4-dien-21-yl Acetate (Prednisolone Acetate)
O
HO
O
O
O
OH
(A) 500 mg
Pharmaceutical impurities
106 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0186.00 Imp. D (Pharmeuropa): 17-Hydroxy-3,11,20-Trioxopregn-4-en-21-yl Acetate (Cortisone Acetate)
O
O
O
O
O
OH
(A) 500 mg
Hydrocortisone 17-Butyrate MM 0188.00 Hydrocortisone 17-Butyrate
O
HO
OOH
O
O
(A) 500 mg
MM 0188.01 Hydrocortisone 21-Butyrate
O
HO
OO
OH
O (A) 100 mg
Hydrocortisone Hydrogen Succinate MM 0185.00 Imp. A (EP): Hydrocortisone
O
HO OH
OOH
(A) 500 mg
MM 0187.00 Imp. B (EP): Hydrocortisone Acetate
O
HO OH
OO
O (A) 500 mg
Hydromorphone Hydrochloride MM 0037.00 Imp. C (EP) as Hydrochloride Trihydrate:
Morphine Hydrochloride Trihydrate [Controlled Substance]
O OHHO
N
x HClx 3 H2O
(A) 250 mg
MM 0280.00 Imp. C (EP) as Hemisulphate Pentahemi- hydrate: Morphine Hemisulphate Pentahemi- hydrate [Controlled Substance]
O OHHO
N
2
x H2SO4x 5 H2O
(A) 250 mg
Hydroxychloroquine Sulphate MM 0764.00 Hydroxychloroquine Sulphate NCl
HNN
OH
x H2SO4(A) 500 mg
MM 0764.02 Desethylhydroxychloroquine Dihydrochloride NCl
HNNH
OH
x 2 HCl(D) 100 mg
MM 0764.04 O-Acetylhydroxychloroquine NCl
HNN
O
O
(A) 100 mg
MM 0764.05 Hydroxychloroquine N-Oxide Dihydrochloride NCl
HNN
OHO
x 2 HCl
(B) 10 mg
Hydroxyethyl Salicylate MM 0112.00 Hydroxyethyl Salicylate
OH
O
O
OH(A) 500 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 107
Code Product Code Unit
MM 0045.00 Imp. A (EP): Salicylic Acid
OH
OH
O (A) 500 mg
Hydroxyzine Hydrochloride MM 0852.00 Hydroxyzine Hydrochloride Cl
NN
OOH
x 2 HCl
(A) 250 mg
MM 0380.01 Imp. A (EP): (RS)-1-[(4-Chlorophenyl)phenylmethyl]piperazine Cl
N
NH (A) 100 mg
MM 0852.02 Imp. B (EP) as Dihydrochloride: 2-[2-[4-(Diphenylmethyl)piperazin-1-yl]ethoxy]-ethanol Dihydrochloride (Decloxizine Dihydrochloride)
NN
OOH
x 2 HCl
(A) 50 mg
Hymechromone MM 0294.00 Hymecromone HO O O (A) 500 mg
MM 0294.01 Imp. A (EP): 1,3-Dihydroxybenzene (Resorcinol) HO OH (B) 100 mg
MM 0294.02 Imp. B (EP): 7-Hydroxy-2-methyl-4H-1-benzopyran-4-one HO O
O
(A) 100 mg
MM 0294.03 2,4-Dihydroxyacetophenone HO
O
OH (B) 100 mg
MM 0294.04 Hymecromone Acetate O O O
O
(A) 100 mg
MM 0294.50 7-Acetoxy-3-acetyl-2-4H-1-benzopyran-4-one O O
O O
O
(A) 100 mg
Hyoscine Butylbromide MM 0683.00 Hyoscine Butylbromide
O
O
OH
N O
H
H
HBr
+
(A) 500 mg
MM 0546.00 Imp. A (EP) as Hydrobromide Trihydrate: Hyoscine Hydrobromide Trihydrate
ON
OH
HO
H
H
x HBrx 3 H2O
OH
H
(A) 500 mg
MM 0601.03 Imp. B (EP): (2RS)-3-Hydroxy-2-phenylpropanoic Acid (DL-Tropic Acid; Tropic Acid) OH
O
OH
(A) 100 mg
Hyoscine Hydrobromide MM 0546.00 Hyoscine Hydrobromide Trihydrate
ON
OH
HO
H
H
x HBrx 3 H2O
OH
H
(A) 500 mg
MM 0546.06 Imp. C (EP): (1R,2R,4S,5S,7s)-9-Methyl-3-oxa- 9-azatricyclo[3.3.1.02,4]non-7-yl 2-Phenylprop- 2-enoate (Apohyoscine) O
NH
O
H
H
OH
H
(A) 100 mg
MM 0601.03 Imp. D (EP): (2RS)-3-Hydroxy-2-phenylpropanoic Acid (DL-Tropic Acid; Tropic Acid) OH
OH
O (A) 100 mg
Pharmaceutical impurities
108 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0546.07 Hyoscine N-Oxide Hydrobromide
ON
OH
HO
H
H
OH
H
Ox HBr
(A) 100 mg
Hyoscyamine Sulphate MM 0601.03 Imp. A (EP): (2RS)-3-Hydroxy-2-phenylpropanoic Acid
(DL-Tropic Acid; Tropic Acid) OH
O
OH
(A) 100 mg
MM 0546.00 Imp. D (EP) as Hydrobromide Trihydrate: Hyoscine Hydrobromide Trihydrate
ON
OH
HO
H
H
x HBrx 3 H2O
OH
H
(A) 500 mg
MM 0289.01 Imp. G (EP) as Hydrochloride: (1R,3r,5S)-8-Methyl-8-azabicyclo[3.2.1]oct-3-yl 2-Phenylprop-2-enoate Hydrochloride (Apoatropine Hydrochloride) O
O
NH x HCl
H
H (D) 100 mg
Ibuprofen MM 0002.00 Ibuprofen
OH
O
(A) 500 mg
MM 0002.13 Imp. A (EP): (2RS)-2-[3-(2-Methylpropyl)phenyl]propanoic Acid OH
O
(A) 100 mg
MM 0002.01 Imp. B (EP):(2RS)-2-(4-Butylphenyl)propanoic Acid OH
O
(A) 100 mg
MM 0002.10 Imp. C (EP): (2RS)-2-[4-(Methylpropyl)phenyl]propanamide NH2
O
(A) 100 mg
MM 0002.11 Imp. D (EP): (2RS)-2-(4-Methylphenyl)propanoic Acid OH
O
(A) 100 mg
MM 0002.04 Imp. E (EP): 1-[4-(2-Methylpropyl)phenyl]ethanone O (A) 100 mg
MM 0002.28 Imp. F (EP): 3-[4-(2-Methylpropyl)phenyl]propanoic Acid OH
O (A) 100 mg
MM 0002.38 Imp. G (EP): (1RS,4RS)-7-(2-Methylpropyl)-1- [4-(2-methylpropyl)phenyl]-1,2,3,4-tetrahydro- naphthalene-1,4-dicarboxylic Acid
O OH
O
OH
and enantiomer
(D) 50 mg
MM 0002.30 Imp. H (EP):(3RS)-1,3-Bis[4-(2-methylpropyl)phenyl]butan-1-one
O (D) 100 mg
MM 0002.31 Imp. I (EP): 1-(2-Methylpropyl)-4-[(3RS)-3- [4-(2-methylpropyl)phenyl]butyl]benzene
(A) 50 mg
MM 0002.02 Imp. J (EP): (2RS)-2-[4-(2-Methylpropanoyl)phenyl]propanoic Acid OH
O
O
(A) 100 mg
MM 0002.26 Imp. K (EP): (2RS)-2-(4-Formylphenyl)propanoic Acid O
OH
O
(A) 100 mg
MM 0002.24 Imp. L (EP): 2-[4-(1-Hydroxy-2-methylpropyl)phenyl]propanoic Acid (1-Hydroxyibuprofen)
OH
OH
O
(A) 100 mg
MM 0002.34 Imp. M (EP): (2RS)-2-Hydroxy-2-[4-(2-methylpropyl)phenyl]propanoic Acid
OH
O
OH (A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 109
Code Product Code Unit
MM 0002.35 Imp. N (EP): (2RS)-2-(4-Ethylphenyl)propanoic Acid OH
O
(A) 100 mg
MM 0002.33 Imp. O (EP): 2-[4-(1-Methylpropyl)phenyl]propanoic Acid OH
O
(A) 100 mg
MM 0002.19 Imp. P (EP):(2RS)-2-[4-(2-Methylpropyl)phenyl]propan-1-ol OH
(A) 100 mg
MM 0002.36 Imp. Q (EP): 2-[4-(2-Methylpropyl)phenyl]ethanol OH (A) 100 mg
MM 0002.37 Imp. R (EP): 1,1'-(Ethane-1,1-diyl)-4,4'-(2- methylpropyl)dibenzene
(A) 100 mg
MM 0002.03 4-Isobutylbenzoic Acid OH
O (A) 100 mg
MM 0002.07 2-(4-Isobutyrylphenyl)propanamide NH2
O
O
(A) 100 mg
MM 0002.08 4-Acetylbenzoic Acid OH
O
O
(A) 100 mg
MM 0002.09 4-Isobutyrylacetophenone O
O
(A) 100 mg
MM 0002.14 2-(4-Isobutyrylphenyl)propane
O
(A) 100 mg
MM 0002.15 2-Hydroxypropyl 2-(4-Isobutylphenyl)propanoate O
O
OH (A) 100 mg
MM 0002.16 1-Hydroxyprop-2-yl 2-(4-Isobutylphenyl)propanoate O
OOH
on request
MM 0002.17 2,3-Dihydroxypropyl 2-(4-Isobutylphenyl)propanoate O
O
OHOH on request
MM 0002.18 1,3-Dihydroxyprop-2-yl 2-(4-Isobutylphenyl)propanonate O
OOH
OH
on request
MM 0002.20 2-(4-n-Propylphenyl)propanoic Acid OH
O
(A) 100 mg
MM 0002.21 2-(4-Isobutylphenyl)propionitrile N
(A) 100 mg
MM 0002.23 Isopropyl 2-(4-Isobutylphenyl)propanonate O
O
(A) 100 mg
MM 0002.25 1-Ethyl-4-isobutylbenzene (A) 100 mg
MM 0002.29 (1RS,4SR)-7-(2-Methylpropyl)-1-[4-(2-methyl- propyl)phenyl]-1,2,3,4-tetrahydronaphthalene- 1,4-dicarboxylic Acid
O OH
O
OH
and enantiomer
(D) 100 mg
MM 0002.32 2-[4-(2-Hydroxy-2-methylpropyl)phenyl]propanoic Acid (2-Hydroxyibuprofen)
HO
OH
O
(A) 100 mg
Pharmaceutical impurities
110 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0002.45 (2SR)-2-(4-Isobutylphenyl)-N-((SR)-1-phenylethyl)propanamide
HN
O
and enantiomer
(A) 100 mg
MM 0002.46 (2SR)-2-(4-Isobutylphenyl)-N-((RS)-1-phenylethyl)propanamide
HN
O
and enantiomer
(A) 100 mg
MM 0002.48 4-Isobutylstyrene (B) 10 mg
MM 0002.50 1-(4-Isobutylphenyl)ethanol OH
(A) 100 mg
MM 0002.51 4-(1-Hydroxy-2-methylpropyl)acetophenone O
OH
(A) 100 mg
MM 0002.53 Ibuprofen Methyl Ester O
O
(A) 100 mg
MM 0002.57 1-(4-Isopropylphenyl)ethanone (4-Isopropylacetophenone)
O (A) 100 mg
MM 0002.59 2-(4-Isopropylphenyl)acrylic Acid OH
O
(C) 50 mg
Idoxuridine MM 0791.00 Idoxuridine
O
HON
HN
O
O
I
OH
(A) 500 mg
Imidocarb Dipropionate MM 0742.00 Imidocarb Dipropionate O
NH
NH
N
HN
HN
N
x 2O
OH
(A) 100 mg
Imipramine Hydrochloride MM 0077.00 Imipramine Hydrochloride
N x HClN
(A) 500 mg
MM 0589.00 Imp. A (EP) as Hydrochloride: 3-(10,11-Dihydro- 5H-dibenzo[b,f]azepin-5-yl)-N-methylpropan-1- amine Hydrochloride (Desipramine Hydrochloride) N
Hx HClN
(A) 250 mg
MM 0077.05 Imp. B (EP): 3-(5H-Dibenzo[b,f]azepin-5-yl)-N,N-dimethylpropan-1-amine (Depramine; 10,11-Dehydroimipramine) NN
(A) 100 mg
MM 0077.08 Imp. C (EP) as Hydrochloride: 10-[3-(Dimethylamino)propyl]acridin-9(10H)-one Hydrochloride
NN
O
x HCl
(A) 100 mg
MM 0077.03 N-[3-(10,11-Dihydro-5H-dibenzo-[b,f]azepin-5-yl)propyl]-N,N',N'-trimethylpropane-1,3-diamine Dihydrochloride
N
x 2 HCl
N N
(B) 10 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 111
Code Product Code Unit
MM 0077.04 10-Hydroxyimipramine BH3-Aduct NN
HO
x BH3
(A) 100 mg
MM 0076.06 Iminodibenzyl
NH
(B) 100 mg
MM 0077.12 Imipramine N-Oxide
NNO
(A) 100 mg
Indanazoline Hydrochloride MM 0588.02 4-Aminoindan Hydrochloride
NH2
x HCl(A) 100 mg
Indapamide MM 0477.00 Indapamide
SH2N
O O
Cl
NH
ON
(A) 250 mg
MM 0477.01 Imp. A (EP): (2RS)-2-Methyl-1-nitroso- 2,3-dihydro-1H-indole ON
N(A) 100 mg
MM 0477.02 Imp. B (EP): 4-Chloro-N-(2-methyl-1H-indol-1-yl)-3-sulphamoylbenzamide S
H2N
O O
Cl
NH
ON
(A) 100 mg
MM 0477.04 4-Chloro-3-sulfamoylbenzoic Acid S
H2N
O O
Cl
OH
O (C) 100 mg
MM 0477.05 N-(4-Chloro-3-sulfamoylbenzoyl)-2-methylindoline S
H2N
O O
Cl
O
N(D) 100 mg
MM 0477.07 Triethylamine N
(C) 100 mg
MM 0477.08 2-Methylindoline HN
(A) 100 mg
MM 0477.09 1-Amino-2-methylindoline Hydrochloride H2N
N x HCl(D) 100 mg
Indometacin MM 0584.00 Indometacin
N
O
O
Cl
OH
O
(A) 500 mg
MM 0063.03 Imp. A (EP): 4-Chlorobenzoic Acid OH
O
Cl
(B) 100 mg
New MM 0584.02 3,4-Dichloroindometacin ([1-(3,4-Dichlorobenzoyl)-5-methoxy-2-methylindol-3-yl]acetic Acid) N
O
O
Cl
OH
O
Cl(A) 50 mg
Indoramin Hydrochloride MM 0802.02 Imp. A (BP): 3-(2-Bromoethyl)indole H
N
Br
(A) 100 mg
Pharmaceutical impurities
112 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Ipecacuanha MM 0131.02 Emetine Dihydrochloride N
HNO
OO
H
O
x 2 HCl(A) 100 mg
Ipratropium Bromide New MM 0289.03 Atropic Acid
OH
O (A) 100 mg
New MM 0601.03 Imp. C (EP): (2RS)-3-Hydroxy-2-phenylpropanoic Acid (Tropic Acid) OH
O
OH
(A) 100 mg
Iprindole Hydrochloride MM 0478.00 Iprindole Hydrochloride
NN
x HCl
(A) 100 mg
Irbesartan MM 0862.01 Imp. A (EP): 1-(Pentanoylamino)-N-[[2'-(1H-
tetrazol-5-yl)biphenyl-4-yl]methyl]cyclo- pentanecarboxamide
NH
NNN
HNO
NHO
(A) 50 mg
Isoamyl Benzoate MM 1086.00 Isoamyl Benzoate
O
O (A) 500 mg
Isoconazol Nitrate MM 0541.00 Isoconazole Nitrate
O
x HNO3
N
N
Cl
Cl
Cl
Cl
(A) 100 mg
MM 0281.01 Imp. A (EP): (1RS)-1-(2,4-Dichlorophenyl)-2-(1H-imidazol-1-yl) ethanol
HO
Cl Cl
N N (A) 100 mg
MM 0541.02 Imp. B (EP) as Nitrate: (2RS)-2-[(2,6-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethanamine Nitrate
O
x HNO3
NH2
Cl
Cl
Cl
Cl
(D) 100 mg
MM 0281.00 Imp. C (EP) as Nitrate: 1-[(2RS)-2-[(2,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole Nitrate (Miconazole Nitrate)
O
x HNO3
N
N
Cl
Cl
ClCl
(A) 500 mg
Isoflurane MM 0500.02 Imp. B (EP): 2-(Difluoromethoxy)-1,1,1-trifluoroethane
FO
FF
F F
(A) 100 mg
MM 0500.03 Imp. C (EP): (2RS)-2-Chloro-2-(chlorodifluoromethoxy)- 1,1,1-trifluoroethane O
Cl
Cl
FFF
F F
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 113
Code Product Code Unit
MM 0500.04 Imp. D (EP): 1,1-Dichloro-1-(difluoromethoxy)-2,2,2-trifluoroethane FO
FClClF
F F
(A) 100 mg
MM 0500.05 Imp. E (EP): 1,1-Dichloro-1-(chlorodifluoromethoxy)-2,2,2- trifluoroethane O
ClCl
Cl
F FF
F F
(A) 100 mg
MM 0500.06 Imp. F (EP): Acetone O (C) 100 mg
Isoproturon MM 2503.02 3-(2-Isopropylphenyl)-1,1-dimethylurea H
N N
O
(A) 100 mg
MM 2503.03 3-(3-Isopropylphenyl)-1,1-dimethylurea HN N
O
(A) 100 mg
Isosorbide Dinitrate MM 0126.05 Imp. B (EP): Isosorbide 2-Nitrate
O
O
HO
O
H
HNO2 (A) 100 mg
MM 0502.00 Imp. C (EP): Isosorbide Mononitrate (Isosorbide 5-Nitrate)
O
O
O
OH
H
H
O2N
(A) 500 mg
MM 0126.01 2-Monomethyl Isosorbide
O
O
HO
O
H
H on request
MM 0126.02 Dimethyl Isosorbide
O
O
O
O
H
H (B) 100 mg
MM 0126.03 Isosorbide
O
O
HO
OH
H
H (A) 500 mg
MM 0126.04 Isomannit Dinitrate
O
O
O
O
H
HNO2
O2N
on request
Isosorbide Mononitrate MM 0502.00 Isosorbide Mononitrate
O
O
O
OH
H
H
O2N
(A) 500 mg
MM 0126.05 Imp. C (EP): Isosorbide 2-Nitrate
O
O
HO
O
H
HNO2 (A) 100 mg
MM 0126.03 Isosorbide
O
O
HO
OH
H
H (A) 500 mg
Isoxsuprine Hydrochloride MM 0576.00 Isoxsuprine Hydrochloride
HO
OH HN
O x HCl
and enantiomere
(A) 500 mg
Pharmaceutical impurities
114 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Itraconazole MM 0258.00 Itraconazole
O O
O
N
NN
Cl Cl
N
N
N
NN
O
and enantiomer
(A) 100 mg
MM 0258.02 Imp. A (EP): 4-[4-[4-(4-Methoxyphenyl)piperazin- 1-yl]phenyl]-2-[(1RS)-1-methylpropyl]-2,4-dihydro- 3H-1,2,4-triazol-3-one
O
N
N
N
NN
O
(A) 100 mg
MM 0258.04 Imp. C (EP): 4-[4-[4-[4-[[cis-2-(2,4-Dichlorophenyl)- 2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]- methoxy]phenyl]piperazin-1-yl]phenyl]-2-propyl- 2,4-dihydro-3H-1,2,4-triazol-3-one
O O
O
N
NN
Cl Cl
N
N
N
NN
O
and enantiomer
(A) 100 mg
MM 0258.05 Imp. D (EP): 4-[4-[4-[4-[[cis-2-(2,4-Dichlorophenyl)- 2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan-4-yl]- methoxy]phenyl]piperazin-1-yl]phenyl]-2-(1- methylethyl)-2,4-dihydro-3H-1,2,4-triazol-3-one
O O
O
N
NN
Cl Cl
N
N
N
NN
O
and enantiomer
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 115
Code Product Code Unit
MM 0258.07 Imp. F (EP): 2-Butyl-4-[4-[4-[4-[[cis-2-(2,4-dichloro- phenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolan- 4-yl]methoxy]phenyl]piperazin-1-yl]phenyl]-2,4- dihydro-3H-1,2,4-triazol-3-one
O O
O
N
NN
Cl Cl
N
N
N
NN
O
and enantiomer
(A) 100 mg
MM 0258.10 2,4-Dihydro-4-[4-[4-(4-methoxyphenyl)-1-piperazinyl]phenyl]-3H-1,2,4-triazol-3-one
O
N
N
N
NHN
O(A) 100 mg
MM 0258.11 cis-2-(2,4-Dichlorophenyl)-2-(1H-1,2,4-triazol-1-ylmethyl)-1,3-dioxolane-4-methanol Mesilate
O O
O
N
NN
Cl Cl
and enantiomer
SO O
(A) 100 mg
Ketamine Hydrochloride MM 0144.00 Ketamine Hydrochloride O
Cl
NHx HCl
(A) 500 mg
MM 0144.01 Imp. A (EP): 1-[(2-Chlorophenyl)- (methylimino)methyl]cyclopentanol
ClNHO
(A) 100 mg
MM 0144.02 Imp. B (EP): (2RS)-2-(2-Chloro- phenyl)-2-hydroxycyclohexanone
OClOH (A) 100 mg
Ketoconazole MM 0145.00 Ketoconazole
O
O
N
Cl
Cl
N
O
NN
O
(A) 500 mg
MM 0145.04 Imp. D (EP): 1-[4-[[(2RS,4SR)-2-(2,4-Dichlorophenyl)-2-(1H-imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl]piperazine
O
O
N
Cl
Cl
N
O
NHN
(A) 100 mg
New MM 0145.05
1-Acetyl-4-(4-hydroxyphenyl)piperazine NN OH
O (A) 100 mg
Ketoprofen MM 0001.00 Ketoprofen
OHO
O
(A) 500 mg
MM 0001.01 Imp. A (EP):1-(3-Benzoylphenyl)ethanone (3-Acetylbenzophenone)
O O (A) 100 mg
Pharmaceutical impurities
116 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0001.03 Imp. B (EP): (3-Benzoylphenyl)acetic Acid OH
O
O
(A) 100 mg
MM 0001.07 Imp. C (EP):3-[(1RS)-1-Carboxylethyl]benzoic Acid HO
OHO
O
(A) 100 mg
MM 0001.12 Imp. D (EP): (2RS)-2-[3-(4-Methylbenzoyl)phenyl]propanoic AcidOH
O
O
(D) 100 mg
MM 0001.05 Imp. E (EP):(2RS)-2-(3-Benzoylphenyl)propanamide NH2
O
O
(A) 100 mg
MM 0001.04 Imp. F (EP): (2RS)-2-(3-Benzoylphenyl)propanenitrile O
N
(A) 100 mg
MM 0001.20 Imp. G (EP): 3-[(1RS)-1-Cyanoethyl]benzoic Acid HO
O
N
(A) 100 mg
MM 0001.22 Imp. H (EP): 3-(Cyanomethyl)benzoic Acid HO
O
N
(A) 100 mg
MM 0001.14 Imp. I (EP): (3-Benzoylphenyl)ethanenitrile O
N
(A) 100 mg
MM 0001.23 Imp. J (EP): (2RS)-2-[3-(2,4-Dimethylbenzoyl)- phenyl]propanoic Acid OH
O
O
(D) 50 mg
MM 0001.02 3-Ethylbenzophenone O (A) 100 mg
MM 0001.11 3-(1-Hydroxyethyl)benzophenone O OH (A) 100 mg
MM 0001.13 3-Methylbenzophenone O (B) 100 mg
MM 0001.17 3-(1-Methoxyethyl)benzophenone O O (A) 100 mg
MM 0001.18 2-[3-(�-Hydroxybenzyl)phenyl]propanoic Acid OHOH
O
(A) 100 mg
MM 0001.19 Ethyl 2-(3-Benzoylphenyl)propionate(Ketoprofen Ethyl Ester) OO
O
(A) 100 mg
MM 0001.21 Isopropyl 2-(3-Benzoylphenyl)propionate OO
O
(A) 100 mg
MM 0001.50 3-(1-Acetoxyethyl)benzophenone O
O
O (A) 100 mg
MM 0001.32 Methyl 2-(3-Benzoylphenyl)propionate (Ketoprofen Methyl Ester)
OO
O
(A) 100 mg
MM 0001.33 2-Ethylhexyl 2-(3-Benzoylphenyl)propionate (Ketoprofen 2-Ethylhexyl Ester) O
O
O
(A) 100 mg
Ketorolac Trometamol MM 0851.00 Ketorolac Trometamol
O
N OH
O
HONH2
OH
OHx
(A) 250 mg
MM 0851.03 Imp. I (EP): Phenyl(2,3-dihydro-1H-pyrrolizin- 5-yl)methanone
O
N
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 117
Code Product Code Unit
Ketotifen Hydrogen Fumarate MM 0180.00 Ketotifen Hydrogen Fumarate
OHHO
O
OS
O
N
x
(A) 250 mg
MM 0180.04 Ketotifen S
O
N (A) 100 mg
MM 0180.08 Imp. B (EP): (4RS)-10-Methoxy-4-(1-methyl- piperidin-4-yl)-4H-benzo[4,5]cyclohepta[1,2- b]thiophen-4-ol
S
O
N
OH
(A) 100 mg
MM 0180.07 Imp. D (EP): 4-[(aRaS)-1-Methylpiperidin-4- ylidene]-4,9-dihydro-10H-benzo[4,5]- cyclohepta[1,2-b]thiophen-10-one N-Oxide (Ketotifen N-Oxide)
S
O
N
O (A) 100 mg
MM 0180.11 10-Methoxy-4H-benzo[4,5]cyclohepta[1,2-b]thiophen-4-one S
O
O(A) 100 mg
Labetalol Hydrochloride MM 0438.00 Labetalol Hydrochloride
HO
OHHN
O NH2
x HCl
(A) 500 mg
Lacidipine MM 0407.00 Lacidipine H
N
O
O
O
O
O
O
(A) 100 mg
MM 0407.01 Imp. A (BP): Ethyl Methyl (E)-4-{2-[2-(tert-Butoxycarbonyl)vinyl]phenyl}-1,4-dihydro-2,6- dimethyl-pyridine-3,5-dicarboxylate
HN
O
O
O
O
O
O
(A) 100 mg
MM 0407.02 Imp. B (BP): Diethyl (E)-4-{2-[2-(tert-Butoxy- carbonyl)vinyl]phenyl}-2,6-dimethylpyridine- 3,5-dicarboxylate
N
O
O
O
O
O
O
(A) 100 mg
Lamivudine MM 0045.00 Imp. C (EP): Salicylic Acid
OH
O
OH
(A) 500 mg
MM 0749.05 Imp. E (EP): 4-Aminopyrimidin-2(1H)-one(Cytosine) N
NH
NH2
O
(A) 100 mg
MM 0593.03 Imp. F (EP): Pyrimidine-2,4(1H,3H)-dione (Uracil) HN
NH
O
O
(C) 100 mg
Pharmaceutical impurities
118 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Lamotrigine MM 0922.00 Lamotrigine N
N
N
ClCl
NH2
NH2
(A) 100 mg
MM 0922.01 Imp. A (EP): 3-Amino-6-(2,3-dichlorophenyl)-1,2,4-triazin-5(4H)-one NN
NH
ClCl
NH2
O
(A) 100 mg
MM 0922.03 Imp. C (EP): (2Z)-[2-(Diaminomethylidene)-diazanylidene](2,3-dichlorophenyl)acetonitrile
NN
NH2
Cl
Cl
NH2
N
(A) 100 mg
New MM 0922.04 Imp. D (EP): 6-(2,3-Dichlorophenyl)-1,2,4- triazine-3,5(2H,4H)-dione N
HN
NH
Cl
Cl
O
O
(A) 50 mg
MM 0922.05 Imp. E (EP): 2,3-Dichlorobenzoic Acid O
OH
ClCl
(A) 100 mg
New MM 0922.07 Imp. G (EP): 6-(2,4-Dichlorophenyl)-1,2,4- triazine-3,5-diamine
NN
N
NH2
NH2Cl
Cl (A) 50 mg
Lansoprazole MM 0474.00 Lansoprazole
N
SO
F
F F
O
NH
N
(A) 100 mg
MM 0474.07 Imp. A (EP): 2-[(RS)-[[3-Methyl-1-oxido- 4-(2,2,2-trifluoroethoxy)pyridin-2-yl]methyl]- sulphinyl]-1H-benzimidazole (Lansoprazole N-Oxide) N
SO
F
F F
O
NH
N
O
(D) 100 mg
MM 0474.01 Imp. B (EP): 2-[[[3-Methyl-4-(2,2,2-trifluoro- ethoxy)pyridin-2-yl]methyl]sulphonyl]-1H-benzimidazole (Lansoprazole Sulphone)
N
SO
F
F FNH
NO O
(A) 100 mg
MM 0474.06 Imp. C (EP): 2-[[[3-Methyl-4-(2,2,2-trifluoro- ethoxy)pyridin-2-yl]methyl]sulphanyl]-1H-benzimidazole
N
SO
F
F FNH
N
(A) 100 mg
MM 0474.03 Imp. D (EP): 1H-Benzimidazol-2-ol
OH
NH
N
(B) 100 mg
MM 0474.05 Imp. E (EP): 1H-Benzimidazole-2-thiol
SH
NH
N
(A) 100 mg
MM 0474.02 Imp. F (EP): 2-[(RS)-[(4-Chloro-3-methylpyridin- 2-yl)methyl]sulphinyl]-1H-benzimidazole
N
SCl
O
NH
N
(A) 100 mg
MM 0474.04 4-Ethoxyacetophenone O
O
(C) 100 mg
MM 0474.08 Lansoprazole Sulphone N-Oxide
N
SO
F
F FNH
NO O
O
(A) 100 mg
MM 0474.09 2-Chloromethyl-3-methyl-4-(2,2,2-trifluoroethoxy)pyridine Hydrochloride
N
ClO
F
F F
x HCl(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 119
Code Product Code Unit
MM 0474.13 1-Methyl-12-thioxopyrido[1',2':3,4]imidazo[1,2-a]benzimidazol-2(12H)-one
NN
N
SO
(D) 100 mg
Leflunomide MM 0859.00 Leflunomide
O F
HN
FF
NO
(D) 100 mg
MM 0859.01 Imp. A (EP) as Hydrochloride: 4-(Trifluoro- methyl)aniline Hydrochloride F
H2N
FF
x HCl(A) 100 mg
MM 0859.02 Imp. B (EP): (2Z)-2-Cyano-3-hydroxy-N-[4- (trifluoromethyl)phenyl]but-2-enamide (Teriflunomide)
O F
HN
FF
N
OH
(A) 100 mg
MM 0859.03 Imp. C (EP): 5-Methyl-N-[3-(trifluoromethyl)- phenyl]isoxazole-4-carboxamide
O
HN
F
F FNO
(A) 100 mg
MM 0859.04 Imp. D (EP): 5-Methylisoxazole-4-carboxylic Acid
O
OH
NO
(A) 100 mg
MM 0859.05 Imp. E (EP): 3-Methyl-N-[4-(trifluoromethyl)-phenyl]isoxazole-4-carboxamide
O
HN
NO
F
F F
(A) 50 mg
MM 0859.06 Imp. F (EP): 5-Methyl-N-[2-(trifluoromethyl)- phenyl]isoxazole-4-carboxamide
O
HN
NO
FFF
(A) 100 mg
MM 0859.07 Imp. G (EP): 5-Methyl-N-(4-methylphenyl)- isoxazole-4-carboxamide
O
HN
NO
(A) 100 mg
New MM 0859.08 Imp. H (EP): 2-Cyano-N-[4-(trifluoromethyl)- phenyl]acetamide
O
HN
F
F F
N (A) 50 mg
Levamisole Hydrochloride New MM 0706.00 Levamisole Hydrochloride
N
SNx HCl (A) 100 mg
MM 0706.04 Imp. D (EP): 6-Phenyl-2,3-dihydro-imidazo[2,1-b]thiazole N
SN (A) 100 mg
Levocetirizine Dihydrochloride MM 1035.00 Levocetirizine Dihydrochloride
N
NO
OH
O
Cl
x 2 HCl
(D) 100 mg
Levodopa MM 0262.00 Levodopa
OH
OHO
HONH2
(A) 500 mg
MM 0634.00 Imp. B (EP): (2S)-2-Amino-3-(4-hydroxy- phenyl)propanoic Acid (Tyrosine) OH
O
HONH2
(A) 100 mg
Pharmaceutical impurities
120 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0262.05 Imp. C (EP): (2RS)-2-Amino-3-(4-hydroxy-3-methoxyphenyl)propanoic Acid (3-Methoxy-DL-tyrosine; (DL)-3-O-Methyldopa)
HONH2
O
OH
O
(A) 100 mg
MM 0262.06 4-Hydroxy-3-methoxymandelic Acid
HO
OHOH
O
O
(A) 100 mg
Levodropropizine MM 1246.02 Imp. B (EP) as Hydrochloride: 1-Phenyl-
piperazine Hydrochloride N
NH
x HCl
(A) 100 mg
Levofloxacin MM 0846.00 Levofloxacin
N
O
N
OF
N
OH
O
(A) 100 mg
Levomenthol MM 0388.00 Levomenthol OH (A) 500 mg
Levomepromazine Hydrochloride MM 0266.00 Levomepromazine Hydrochloride
x HClN
S
O
N
(A) 500 mg
Levomepromazine Maleate MM 0019.00 Levomepromazine Maleate O
OH
O
OHx
N
S
O
N
(A) 100 mg
MM 0019.02 Imp. A (EP): 2-Methoxyphenothiazine NH
S
O
(A) 100 mg
MM 0019.01 Imp. B (EP): 10-[(2R)-3-(Dimethylamino)-2- methylpropyl]-2-methoxy-10H-phenothiazine 5-Oxide (Levomepromazine S-Oxide)
N
S
O
N
O
(A) 100 mg
MM 0019.07 N-Demethyllevomepromazine Hydrochloride
x HClN
S
O
NH
(D) 100 mg
MM 0019.09 Levomepromazine Sulphone Hydrochloride N
S
O
N
OO
x HCl
(A) 100 mg
Levonorgestrel MM 0121.00 Levonorgestrel OH
O
(A) 250 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 121
Code Product Code Unit
MM 0121.08 Imp. G (Pharmeuropa): 13-Ethyl-6��17- dihydroxy-18,19-dinor-17�-pregn-4-en- 20-yn-3-one (6�-Hydroxylevonorgestrel)
OH
OOH
(D) 50 mg
MM 0121.01 Imp. H (Pharmeuropa): 13-Ethyl-6��17- dihydroxy-18,19-dinor-17�-pregn-4-en- 20-yn-3-one (6�-Hydroxylevonorgestrel)
OH
OOH
(D) 100 mg
MM 0121.02 Imp. J (Pharmeuropa): 13-Ethyl-17-hydroxy- 18,19-dinor-17�-pregn-4-en-20-yn-3,6-dione (6-Oxolevonorgestrel, 6-Ketolevonorgestrel)
OH
OO
(D) 100 mg
MM 0121.12 Imp. L (Pharmeuropa): 13-Ethylgon-4-ene-3,17- dione (Levodione, 18-Methyl-19-norandrost-4- ene-3,17-dione)
O
O
(D) 100 mg
MM 0121.11 Imp. M (Pharmeuropa): 13-Ethyl-17-hydroxy- 18,19-dinor-17�-pregna-4,6-dien-20-yn-3-one (�6-Levonorgestrel, 6,7-Didehydrolevonorgestrel)
OH
O
(D) 100 mg
Lidocaine Hydrochloride MM 0102.04 Lidocaine Hydrochloride Monohydrate
O
HN
N x HClx H2O
(A) 500 mg
MM 0102.00 Lidocaine
O
HN
N(A) 500 mg
MM 0102.02 Imp. A (EP): 2,6-Dimethylaniline NH2
(B) 100 mg
MM 0102.08 Imp. C (EP): N-(2,6-Dimethylphenyl)acetamide
O
HN (A) 100 mg
MM 0102.01 Imp. B (EP): 2-(Diethylazinoyl)-N-(2,6- dimethylphenyl)acetamide (Lidocaine N2-
Oxide) O
HN
NO (A) 100 mg
MM 0102.05 Imp. D (EP) as Hydrochloride: N-(2,6- Dimethylphenyl)-2-(ethylamino)acetamide Hydrochloride (Monoethylglycinexylidide Hydrochloride)
O
HN
NH
x HCl(A) 100 mg
MM 0102.09 Imp. E (EP) as Hydrochloride: 2,2'- (Azanediyl)bis[N-(2,6-dimethylphenyl)- acetamide] Hydrochloride O
HN
NH
HN
O
x HCl(A) 100 mg
MM 0102.10 Imp. F (EP) as Hydrochloride: 2-(Diethyl- amino)-N-(2,3-dimethylphenyl)acetamide Hydrochloride O
HN
N x HCl(A) 100 mg
MM 0102.11 Imp. G (EP) as Hydrochloride: N-(2,6- Dimethylphenyl)-2-[(1-methylethyl)amino]- acetamide Hydrochloride O
HN
NH
x HCl(A) 100 mg
MM 0102.03 Imp. H (EP): 2-Chloro-N-(2,6-dimethylphenyl)acetamide HN
O
Cl(B) 100 mg
New MM 0102.12 Imp. I (EP) as Hydrochloride: 2-(Diethylamino)- N-(2,4-dimethylphenyl)acetamide Hydrochloride
O
HN
N x HCl(A) 100 mg
MM 0102.14 Imp. K (EP) as Hydrochloride: N-(2,6-Dimethyl- phenyl)-2-(ethylmethylamino)acetamide Hydro- chloride O
HN
N x HCl(A) 100 mg
High purity solvents
• Range of over 80 solvents
• Picograde® solvents for residue analysis
• Optigrade® solvents for HPLC
• LC MS solvents, additives and mixtures
• New UHPLC solvents for Ultra HighPerformance Liquid Chromatography (UHPLC)
• Headspace solvents
• Compatible with FLORISIL® adsorbents, also available
LGC Standards Promochem® brand solvents for high accuracy measurement
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www.lgcstandards.comNo part of this publication may be reproduced or transmitted in any form or byany means, electronic or mechanical, including photocopying, recording or anyretrieval system, without the written permission of the copyright holder. © LGC Standards, 2011. All rights reserved. 2787/SR/0111
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 123
Code Product Code Unit
Liothyronine Sodium MM 0626.00 Liothyronine Sodium
O
IHO I
I
ONa
O
NH2
(A) 50 mg
MM 0626.01 Liothyronine O
IHO I
I
OH
O
NH2
(A) 100 mg
Lisinopril Dihydrate MM 0598.00 Lisinopril Dihydrate
HN
OHO
N
OO
OH
x 2 H2O
H2N
(A) 100 mg
MM 0598.01 Imp. A (EP): (2RS)-2-Amino-4-phenylbutanoic Acid NH2
OHO
(A) 100 mg
MM 0598.02 Imp. B (EP) as Hydrate: 4-Methylbenzenesulphonic Acid Hydrate S
OH
O O
x H2O(C) 100 mg
Lomustine MM 0923.02 Imp. B (EP): 1-(2-Chloroethyl)-3-cyclohexylurea
NH
NH
O
Cl(A) 100 mg
MM 0923.03 Imp. C (EP): 1,3-Dicyclohexylurea NH
NH
O (A) 100 mg
Loperamide Hydrochloride MM 0025.00 Loperamide Hydrochloride Cl
x HClN
OH
O
N
(A) 500 mg
MM 0025.15 Imp. B (EP) as Bromide: 4-(4-Chlorophenyl)- 1,1-bis[4-(dimethylamino)-4-oxo- 3,3-diphenylbutyl]-4-hydroxypiperidinium Bromide
N+
O
N
ON
OH
ClBr-
on request
MM 0025.04 Imp. C (EP): 4-(4-Chlorophenyl)piperidin-4-ol Cl
NH
OH
(B) 100 mg
MM 0025.05 Imp. D (EP): 4-(4-Hydroxy-4-phenylpiperidin-1-yl)-N,N-dimethyl-2,2-diphenylbutanamide
N
OH
O
N
(A) 100 mg
Pharmaceutical impurities
124 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0025.09 Imp. F (EP): Loperamide Oxide
N
O
N
OHCl
O
(A) 100 mg
MM 0025.11 Imp. H (EP): 4-[4-(4-Chlorophenyl)-3,6- dihydropyridin-1(2H)-yl]-N,N-dimethyl-2,2- diphenylbutanamide
N
O
N
Cl (A) 100 mg
MM 0025.07 Ethyl Diphenylacetate
O
O
(A) 100 mg
MM 0025.08 �,�-Diphenyl--butyrolactone O
O
(A) 100 mg
MM 0025.10 Dimethyl-(tetrahydro-3,3-diphenyl-2-furilidine)ammonium Bromide
Br-
O
N+
(A) 100 mg
Loratadine MM 0257.00 Loratadine
N O
O
N
Cl (A) 100 mg
MM 0257.03 Imp. A (EP): Ethyl 4-[(11RS)-8-Chloro-11- hydroxy-6,11-dihydro-5H-benzo[5,6]cyclo- hepta[1,2-b]pyridin-11-yl]piperidine-1- carboxylate
N O
O
N
Cl
OH
(A) 100 mg
MM 0257.02 Imp. B (EP): 8-Chloro-5,6-dihydro-11H-benzo[5.6]cyclohepta[1,2-b]pyridin-11-one
O
N
Cl (A) 100 mg
MM 0257.08 Imp. C (EP): Ethyl 4-(4,8-Dichloro-5,6-dihydro- 11H-benzo[5,6]cyclohepta[1,2-b]pyridin-11- ylidene)piperidine-1-carboxylate
N O
O
N
Cl
Cl
(D) 100 mg
MM 0257.01 Imp. D (EP): 8-Chloro-11-(piperidin-4-ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine (Descarboethoxyloratadine;Desloratadine)
NH
N
Cl (A) 50 mg
MM 0257.05 Imp. G (EP): 8-Chloro-11-(1-methylpiperidin-4- ylidene)-6,11-dihydro-5H-benzo[5,6]cyclohepta- [1,2-b]pyridine
N
N
Cl (A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 125
Code Product Code Unit
MM 0257.07 Imp. H (EP): Ethyl 4-Oxopiperidine-1-carboxylate N O
O
O
(A) 100 mg
MM 0257.06 (11RS)-8-Chloro-11-hydroxy-11-(1-methylpiperidin-4-yl)-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridine N
N
Cl
OH
(A) 100 mg
LorazepamMM 0071.00 Lorazepam
[Controlled Substance]N
HN
O
Cl
Cl
OH
(A) 100 mg
MM 0071.01 Imp. A (EP): (2-Amino-5-chlorophenyl)(2-chlorophenyl)methanone (2-Amino-2',5-dichlorobenzophenone) Cl
NH2
O
Cl
(B) 100 mg
MM 0071.07 Imp. B (EP): (3RS)-7-Chloro-5-(2-chlorophenyl)- 2-oxo-2,3-dihydro-1H-1,4-benzodiazepin-3-yl Acetate (Lorazepam Acetate)[Controlled Substance]
N
HN
O
Cl
Cl
O
O
(A) 100 mg
MM 0071.06 Imp. C (EP): 7-Chloro-5-(2-chlorophenyl)- 1,3-dihydro-2H-1,4-benzodiazepin-2-one 4-Oxide N
HN
O
Cl
ClO
(A) 100 mg
MM 0071.03 Imp. D (EP): (5RS)-7-Chloro-5-(2-chlorophenyl)- 4,5-dihydro-1H-1,4-benzodiazepine-2,3-dione
NH
HN
O
Cl
Cl
O
(A) 100 mg
MM 0071.02 Imp. E (EP): 6-Chloro-4-(2-chlorophenyl)- quinazoline-2-carbaldehyde
Cl
N
N
Cl
O (A) 100 mg
MM 0071.04 6-Chloro-4-(2-chlorophenyl)-2-quinazolinecarboxylic Acid
Cl
N
N
Cl
O
OH
(A) 100 mg
MM 0071.08 6-Chloro-4-(2-chlorophenyl)-2-quinazolinemethanol
Cl
N
N
Cl
OH (A) 100 mg
MM 0071.09 6-Chloro-4-(2-chlorophenyl)-2(1H)-quinazolinone
N
HN
Cl
O
Cl
(A) 100 mg
Losartan Potassium MM 0168.00 Losartan
N
N
OH
ClNH
NNN
on request
Pharmaceutical impurities
126 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0168.14 Imp. B (Pharmeuropa) : [2'-(1H-Tetrazol-5-yl)biphenyl-4-yl]methanol N
NNHN
HO
(A) 50 mg
MM 0168.04 Imp. C (Pharmeuropa) : [2-Butyl-5-chloro-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-imidazol-4-yl]methanol
N
N
ClN
NNHN
HO
(D) 50 mg
MM 0168.08 Imp. D (EP) : 2-Butyl-4-chloro-1H-imidazole-5-carbaldehyde
NH
N
O
Cl
(A) 100 mg
MM 0168.05 Imp. E (EP): 5-(4'-Methylbiphenyl-2-yl)-1H-tetrazole N
NNHN
(A) 50 mg
MM 0168.15 Imp. F (EP): 5-[4'[[2-Butyl-4-chloro-5-[[(1- methylethyl)oxy]methyl]-1H-imidazol-1-yl]- methyl]biphenyl-2-yl]-1H-tetrazole (Losartan Isopropyl Ether)
N
N
O
Cl
NNN
HN
(A) 100 mg
MM 0173.04 Imp. G (EP) : Triphenylmethanol OH
(A) 100 mg
MM 0168.16 Imp. H (EP) : [2-Butyl-4-chloro-1-[[2'-[2- (triphenylmethyl)-2H-tetrazol-5-yl]biphenyl- 4-yl]methyl]-1H-imidazol-5-yl]methanol
N
N
OH
Cl
NNN
N
(A) 100 mg
MM 0168.18 Imp. J (EP) : [2-Butyl-4-chloro-1-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]-1H-imidazol-5-yl]methyl Acetate
N
N
O
Cl
NNN
HN
O (A) 100 mg
MM 0168.12 Losartan Methyl Ether
N
N
O
Cl
NNN
HN
(A) 100 mg
Lovastatin MM 0050.00 Lovastatin
HO O
O
O
OH
(A) 100 mg
MM 0377.00 Imp. A (EP): (1S,7S,8S,8aR)-8-[2-[(2R,4R)-4-Hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl]-7-methyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl (2S)-2-Methylbutanoate (Mevastatin)
O
O
OHO O
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 127
Code Product Code Unit
MM 0050.01 Imp. B (EP) as Sodium Salt: (3R,5R)-7-[(1S,2S,6R,8S,8aR)-2,6-Dimethyl-8-[[(2S)-2-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl]-3,5-dihydroxyheptanoic Acid Sodium Salt (Lovastatin Hydroxy Acid Sodium Salt)
HO O
OH
OH
O
ONa
(A) 100 mg
MM 0050.03 Imp. C (EP): (1S,3R,7S,8S,8aR)-3,7-Dimethyl-8-[2-[(2R)-6-oxo-3,6-dihydro-2H-pyran-2-yl]ethyl]-1,2,3,7,8,8a-hexahydronaphthalen-1-yl (2S)-2-Methylbutanoate (Dehydrolovastatin) H
O O
O
O (A) 100 mg
Malic Acid New MM 1332.01 Imp. A (EP): (E)-Butenedioic Acid (Fumaric Acid)
OH
O
HO
O
(B) 100 mg
Maprotiline Hydrochloride MM 0820.00 Maprotiline Hydrochloride
NH x HCl
(A) 250 mg
MM 0820.01 Imp. A (EP): 3-(9,10-Ethanoanthracen-9(10H)-yl)prop-2-enal O
(A) 50 mg
MM 0820.02 Imp. B (EP) as Hydrochloride: 3-(9,10-Ethanoanthracen-9(10H)-yl)-N-[3-(9,10-ethanoanthracen-9(10H)-yl)propyl]-N-methylpropan-1-amine Hydrochloride
N x HCl
(C) 10 mg
MM 0820.03 Imp. C (EP) as Hydrochloride: 3-(9,10-Ethanoanthracen-9(10H)-yl)propan-1-amine Hydrochloride NH2 x HCl
(C) 10 mg
MM 0820.04 Imp. D (EP) as Hydrochloride: 3-(9,10-Ethanoanthracen-9(10H)-yl)-N-methylprop-2-en-1-amine Hydrochloride (Dehydromaprotiline Hydrochloride)
NH x HCl
(A) 50 mg
MM 0820.05 Imp. E (EP) as Hydrochloride: 3-(9,10-Ethanoanthracen-9(10H)-yl)-N,N-dimethylpropan-1-amine Hydrochloride N x HCl
(A) 100 mg
Mebendazole MM 0882.06 Imp. F (EP): Methyl [5-(4-Methylbenzoyl)-1H-
benzimidazol-2-yl]carbamate
O
N
HN
NHO
O (A) 50 mg
MM 0882.05 Imp. E (EP): Ethyl (5-Benzoyl-1H-benzimidazol-2-yl)carbamate
O
N
HN
NHO
O (A) 50 mg
MM 0882.02 Imp. B (EP): (2-Hydroxy-1H-benzimidazol-5- yl)phenylmethanone
O
N
HN
OH(A) 50 mg
MM 0882.04 Imp. D (EP): Methyl (5-Benzoyl-1-methyl-1H- benzimidazol-2-yl)carbamate
O
N
NNH
OO (A) 50 mg
Pharmaceutical impurities
128 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Mebeverine Hydrochloride MM 0319.00 Mebeverine Hydrochloride
O
NO
O
O
O
x HCl
(A) 100 mg
MM 0319.02 Imp. A (Pharmeuropa): 4-Methoxyphenylacetone
O
O (B) 100 mg
MM 0319.03 Imp. B (Pharmeuropa) as Hydrochloride: N-[(1RS)- 1-[(4-Methoxyphenyl)methyl]ethyl]ethanamine Hydrochloride
O
NH x HCl
(A) 100 mg
MM 0319.01 Imp. D (Pharmeuropa): 3,4-Dimethoxybenzoic Acid (Veratric Acid)
O
HO
O
O
(B) 100 mg
Mechlorethamine Hydrochloride MM 0823.00 Mechlorethamine Hydrochloride N
Cl Clx HCl (A) 500 mg
Meclofenoxate Hydrochloride MM 0044.00 Meclofenoxate Hydrochloride
Cl
OO
ON
x HCl
(A) 500 mg
MM 0044.02 (4-Chlorophenoxy)acetic Acid
Cl
OOH
O (B) 100 mg
Meclozine Hydrochloride MM 0586.00 Meclozine Dihydrochloride
N
ClN
x 2 HCl
(A) 500 mg
MM 0380.09 Imp. B (Pharmeuropa): (RS)-(4-Chlorophenyl)(phenyl)methanol (4-Chlorobenzhydrol) OH
Cl (B) 100 mg
MM 0380.10 Imp. C (Pharmeuropa): (4-Chlorophenyl)- (phenyl)methanone (4-Chlorobenzophenone) O
Cl (B) 100 mg
MM 0380.04 Imp. F (Pharmeuropa): 1,4-Bis[(4-chlorophenyl)- phenylmethyl]piperazine
N
NCl
Cl
(A) 100 mg
MM 0380.01 Imp. H (Pharmeuropa): 1-[(RS)-(4-Chlorophenyl)- phenylmethyl]piperazine ((RS)-1-[(4-Chlorophenyl)- phenylmethyl]piperazine)
NNH
Cl (A) 100 mg
MM 0586.05 Meclozine N-Oxide
N
ClNO (B) 10 mg
MM 0586.07 N-(3-Methylbenzyl)piperazine Dihydrochloride N
HNx 2 HCl (A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 129
Code Product Code Unit
MM 0586.08 Imp. D (Pharmeuropa): 1,1'-(Benzene-1,3-diyldimethanediyl) bis[4-[(4-chlorophenyl)-phenylmethyl]piperazine]
Cl
N
N
N
N
Cl
(A) 50 mg
MM 0586.09 Imp. E (Pharmeuropa): 1-(Diphenylmethyl)- 4-(3-methylbenzyl)piperazine N
N (A) 50 mg
Medroxyprogesterone MM 0635.00 Medroxyprogesterone
O
OOH
(A) 100 mg
Medroxyprogesterone Acetate MM 0532.00 Medroxyprogesterone Acetate
O
OO
O
(A) 100 mg
MM 0532.01 Imp. A (EP): 6�-Hydroxy-6-methyl-3,20-dioxopregn-4-en-17-yl Acetate (6�-Hydroxymedroxyprogesterone Acetate)
O
OO
O
OH
(D) 100 mg
MM 0635.00 Imp. B (EP):17-Hydroxy-6�-methylpregn-4-ene-3,20-dione (Medroxyprogesterone)
O
OOH
(A) 100 mg
MM 0532.05 Imp. E (EP): 6-Methylidene-3,20-dioxopregn-4-en-17-yl Acetate (6-Methylenehydroxyprogesterone Acetate)
O
OO
O
(A) 100 mg
MM 0532.06 Imp. F (EP): 6�-Methyl-3,20-dioxo-5�-pregnan-17-yl Acetate (4,5�-Dihydromedroxyprogesterone Acetate)
O
O
O
O
H
(D) 50 mg
MM 0532.07 Imp. G (EP): 6-Methyl-3,20-dioxopregna-4,6-dien-17-yl Acetate (Megestrol Acetate)
O
OO
O
(A) 250 mg
MM 0532.09 Imp. H (EP): 3,20-Dioxopregn-4-en-17-yl Acetate (Hydroxyprogesterone Acetate)
O
O
O
O
(A) 100 mg
Mefenamic Acid MM 0327.00 Mefenamic Acid
OH
O
NH
(A) 500 mg
Pharmaceutical impurities
130 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0327.01 Imp. A (EP): 2,3-Dimethylaniline NH2 (B) 100 mg
MM 0327.02 Imp. B (EP): N-(2,3-Dimethylphenyl)-2-[(2,3-dimethylphenyl)amino]benzamide
NH
O
NH
(A) 100 mg
MM 0217.14 Imp. C (EP): 2-Chlorobenzoic Acid OH
O
Cl
(A) 100 mg
MM 0278.01 Imp. D (EP): Benzoic Acid OH
O (B) 100 mg
Mefloquine Hydrochloride MM 1198.01 2,8-Bis-(trifluoromethyl)-4-quinolinol
NF
F F
OH
FFF
(A) 100 mg
Megestrol Acetate MM 0532.07 Megestrol Acetate
O
O
O
O
(A) 250 mg
MM 0532.00 Imp. A (EP): 6�-Methyl-3,20-dioxopregn-4-en-17-yl Acetate (Medroxyprogesterone Acetate)
O
O
O
O
(A) 100 mg
New MM 0532.09 Imp. K (Pharmeuropa): 3,20-Dioxopregn-4-en-17-yl Acetate
O
O
O
O
(A) 100 mg
Meloxicam MM 0246.00 Meloxicam
NS
O O
OH O
HN
S
N
(A) 500 mg
MM 0084.03 Imp. A (EP): Ethyl 4-Hydroxy-2-methyl- 2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide N
SO O
OH O
O
(A) 100 mg
MM 0246.01 Imp. B (EP): 5-Methylthiazol-2-amine S
NH2N (A) 100 mg
MM 0246.16 Imp. C (EP): N-[(2Z)-3,5-Dimethylthiazol-2(3H)- ylidene]-4-hydroxy-2-methyl-2H-1,2-benzothiazine- 3-carboxamide 1,1-Dioxide
NS
OH O
N
S
N
O O (A) 50 mg
MM 0246.17 Imp. D (EP): N-[(2Z)-3-Ethyl-5-methylthiazol-2(3H)-ylidene]-4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxamide 1,1-Dioxide
NS
OH O
N
S
N
O O (A) 50 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 131
Code Product Code Unit
MM 0084.02 Imp. E (EP): Methyl 4-Hydroxy-2-methyl- 2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide N
SO O
OH O
O
(A) 100 mg
MM 0084.12 Imp. F (EP): Isopropyl 4-Hydroxy-2-methyl-2H- 1,2-benzothiazine-3-carboxylate 1,1-Dioxide (1-Methylethyl 4-Hydroxy-2-methyl-2H-1,2- benzothiazine-3-carboxylate 1,1-Dioxide)
NS
OH O
O
O O (A) 100 mg
Melperone MM 0321.00 Melperone
F
ON
(A) 100 mg
Memantine Hydrochloride MM 1045.01 1-Hydroxy-3,5-dimethyladamantane OH (A) 100 mg
MM 1045.04 1-Chloro-3,5-dimethyladamantane Cl (A) 100 mg
Mephenesin MM 0810.00 Mephenesin
OOH
OH(A) 500 mg
Mephentermine Hemisulphate MM 0740.00 Mephentermine Hemisulfate H
Nx ½ H2SO4
(A) 500 mg
Mepivacaine Hydrochloride MM 0368.00 Mepivacaine Hydrochloride
HN
O
N x HCl
(A) 500 mg
MM 0102.02 Imp. A (EP): 2,6-Dimethylaniline NH2
(B) 100 mg
MM 0368.02 Imp. B (EP) as Hydrochloride: (RS)-N-(2,6- Dimethylphenyl)piperidine-2-carboxamide Hydrochloride
HN
O
NH
x HCl
(A) 50 mg
MM 0368.03 Imp. C (EP): N-(2,6-Dimethylphenyl)pyridine-2-carboxamide HN
O
N
(A) 100 mg
MM 0368.06 Mepivacaine N-Oxide HN
O
NO
(A) 100 mg
Mepyramine Maleate MM 0559.00 Mepyramine Maleate
O
OH
O
OHxN
N
O N
(A) 500 mg
MM 0559.02 Imp. A (EP): N-(4-Methoxybenzyl)pyridin-2-amine NH
O N
(A) 100 mg
MM 0164.03 Imp. B (EP): 4-Methoxybenzaldehyde (Anisaldehyde) O
O (C) 100 mg
MM 0084.01 Imp. C (EP): Pyridin-2-amine N
NH2 (B) 100 mg
Pharmaceutical impurities
132 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0559.05 Mepyramine N-Oxide Dihydrochloride N
N
O N
O
x 2 HCl
(A) 100 mg
Mequinol MM 1131.00 Mequinol
HO
O (A) 500 mg
Mesalazine MM 0217.00 Mesalazine
OH
OHH2N
O (A) 500 mg
MM 0042.01 Imp. A (EP): 4-Aminophenol H2N
OH
(B) 100 mg
MM 0042.07 Imp. B (EP): 3-Aminophenol OHH2N
(B) 100 mg
MM 0217.06 Imp. C (EP): 2-Aminophenol OH
NH2
(A) 100 mg
MM 0217.07 Imp. D (EP): 3-Aminobenzoic Acid OH
O
NH2
(A) 100 mg
MM 0217.09 Imp. F (EP): 3-Amino-2-hydroxybenzoic Acid (3-Aminosalicylic Acid) OH
O
OHNH2
(A) 100 mg
MM 0217.10 Imp. G (EP): 2,5-Dihydroxybenzoic Acid OH
O
OH
HO(A) 100 mg
MM 0045.00 Imp. H (EP): 2-Hydroxybenzoic Acid (Salicylic Acid) OH
O
OH
(A) 500 mg
MM 0217.12 Imp. I (EP): 2-Hydroxy-5-(phenyldiazenyl)benzoic Acid (Phenylazosalicylic Acid) OH
O
OH
NN
(A) 50 mg
MM 0093.17 Imp. K (EP) as Hydrochloride: Aniline Hydrochloride H2Nx HCl
(B) 100 mg
MM 0217.14 Imp. L (EP): 2-Chlorobenzoic Acid OH
O
Cl
(A) 100 mg
MM 0217.15 Imp. M (EP): 2-Chloro-5-nitrobenzoic Acid OH
O
Cl
O2N(A) 100 mg
MM 0217.16 Imp. N (EP): 2-Hydroxy-5-nitrobenzoic Acid (5-Nitrosalicylic Acid) OH
O
OH
O2N(A) 100 mg
MM 0227.04 Imp. O (Pharmeuropa): 4-Aminobenzene- sulphonic Acid (Sulphanilic Acid)
H2N
SOH
O O
(A) 100 mg
MM 0217.02 5-Acetaminosalicylic Acid OH
O OH
NH
O
(A) 100 mg
Metamizole Sodium MM 0052.00 Metamizole Sodium Monohydrate
NN
ON S
O O
ONa x H2O
(A) 500 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 133
Code Product Code Unit
MM 0052.02 Imp. A (EP): 4-Formylamino-1,5-dimethyl-2-phenyl-1,2-dihydro-3H-pyrazol-3-one (4-Formylaminophenazone) N
N
O HN O (A) 100 mg
MM 0052.04 Imp. B (EP): 4-Amino-1,5-dimethyl-2-phenyl-1,2-dihydro-3H-pyrazol-3-one (Ampyrone) N
N
ONH2
(A) 100 mg
MM 0052.10 Imp. C (EP) as Hydrochloride: 4-Methylamino-1,5-dimethyl-2-phenyl-1,2-dihydro-3H-pyrazol-3-one Hydrochloride (4-Methylaminophenazone Hydrochloride)
NN
O HN
x HCl
(A) 100 mg
MM 0052.05 Imp. D (EP): 4-Dimethylamino-1,5-dimethyl-2-phenyl-1,2-dihydro-3H-pyrazol-3-one (4,4-Dimethylaminophenazone) N
N
ON
(A) 100 mg
MM 0052.01 4-Acetylaminophenazone N
N
O HN O (A) 100 mg
MM 0052.50 4-Benzylideneaminoantipyrine
NN
ON
(A) 100 mg
Metformin Hydrochloride MM 0056.00 Metformin Hydrochloride NH
H2N NH
N
NHx HCl
(A) 500 mg
MM 0056.01 Imp. A (EP): Cyanoguanidine NH
H2N NH
N (B) 100 mg
MM 0056.07 Imp. B (EP) as Nitrate: (4,6-Diamino-1,3,5- triazin-2-yl)guanidine Nitrate N N
NH2N NH
NH2
NH
NH2
x HNO3
(A) 100 mg
MM 0056.03 Imp. C (EP): N,N-Dimethyl-1,3,5-triazine-2,4,6-triamine
N N
NH2N N
NH2
(A) 100 mg
MM 0056.04 Imp. D (EP): 1,3,5-Triazine-2,4,6-triamine (Melamine)N N
NH2N NH2
NH2
(B) 100 mg
MM 0056.05 Imp. E (EP) as Hydrochloride:1-Methylbiguanide Hydrochloride NH
H2N NH
NH
NHx HCl
(A) 100 mg
MM 0056.06 Imp. F (EP) as Hydrochloride: N-Methylmethanamine Hydrochloride HN x HCl (C) 100 mg
Methadone Hydrochloride MM 0531.06 Imp. E (EP): Diphenylacetonitrile
N(A) 100 mg
Methamphetamine Hydrochloride MM 0964.00 Methamphetamine Hydrochloride
[Controlled Substance] HN
x HCl(A) 100 mg
Methotrexate MM 0040.00 Methotrexate
N
NN
N
NH2
H2N
N
NH
OO OH
O
OH
(A) 500 mg
MM 0040.08 Imp. A (EP) as Hydrochloride: (2,4-Diaminopteridin-6-yl)methanol Hydrochloride
N
NN
N
NH2
H2N
OH x HCl
(A) 100 mg
Pharmaceutical impurities
134 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Methoxsalen MM 0555.00 Methoxsalen
O OOO (A) 500 mg
MM 0555.01 5-Methoxypsoralen (Bergapten) O OO
O
(A) 100 mg
Methoxyphenamine Hydrochloride MM 0655.00 Methoxyphenamine Hydrochloride
O
HN
x HCl
(A) 500 mg
Methyl Nicotinate MM 0549.00 Methyl Nicotinate
N O
O (A) 500 mg
MM 0553.00 Imp. A (EP): Nicotinic Acid N OH
O (A) 500 mg
Methyl Parahydroxybenzoate MM 0431.00 Methyl Parahydroxybenzoate
HO
O
O (A) 500 mg
MM 0045.01 Imp. A (EP): 4-Hydroxybenzoic Acid
HO
OH
O (B) 100 mg
MM 0498.00 Imp. B (EP): Ethyl 4-Hydroxybenzoate (Ethyl Parahydroxybenzoate)
HO
O
O (A) 500 mg
MM 0432.00 Imp. C (EP): Propyl 4-Hydroxybenzoate (Propyl Parahydroxybenzoate)
HO
O
O (A) 500 mg
MM 0496.00 Imp. D (EP): Butyl 4-Hydroxybenzoate (Butyl Parahydroxybenzoate)
HO
O
O (A) 500 mg
MM 0431.01 Sodium Methyl Parahydroxybenzoate
NaO
O
O (A) 500 mg
Methylphenidate Hydrochloride MM 1031.04 Ritalinic Acid
HN
OHO (A) 100 mg
Methylprednisolone MM 0190.00 Methylprednisolone
O
HO
OOH
OH(A) 100 mg
MM 0190.01 Imp. A (EP): 17,21-Dihydroxy-6�-methylpregna-1,4-diene-3,11,20-trione
O
O
OOH
OH(D) 50 mg
Methylprednisolone Acetate MM 0191.00 Methylprednisolone Acetate
O
HO
OO
OH
O (D) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 135
Code Product Code Unit
MM 0190.00 Imp. B (EP): Methylprednisolone
O
HO
OOH
OH(A) 100 mg
MM 0194.00 Imp. E (EP): Prednisolone Acetate
O
HO
OO
OH
O (A) 500 mg
Methylprednisolone Hydrogen Succinate MM 0192.00 Methylprednisolone Hydrogen Succinate Sodium Salt
O
HO
OO
OH
OONa
O
on request
MM 0190.00 Imp. A (EP): Methylprednisolone
O
HO
OOH
OH(A) 100 mg
MM 0191.00 Imp. C (EP): Methylprednisolone Acetate
O
HO
OO
OH
O (D) 100 mg
Methyltestosterone MM 0558.00 Methyltestosterone
O
OH (A) 250 mg
MM 0323.00 Testosterone
O
OH (A) 500 mg
Metixene Hydrochloride MM 0125.01 Imp. A (EP): 9H-Thioxanthene
S
(A) 100 mg
MM 0125.02 Imp. B (EP): 9H-Thioxanthen-9-one (Thioxanthone)
S
O(B) 100 mg
MM 0125.03 3-Chloromethyl-1-methylpiperidine Cl
N
on request
Metoclopramide MM 0073.00 Metoclopramide Hydrochloride Monohydrate
OH2N
ClNH
ON x HCl
x H2O
(A) 500 mg
MM 0073.03 Imp. A (EP): 4-(Acetylamino)-5-chloro-N-[2-(diethylamino)ethyl]-2-methoxybenzamide
ONH
ClNH
ON
O
(A) 100 mg
MM 0073.04 Imp. B (EP): Methyl 4-(Acetylamino)-5-chloro-2-methoxybenzoate
ONH
ClO
O O
(A) 100 mg
MM 0073.02 Imp. C (EP): 4-Amino-5-chloro-2-methoxybenzoic Acid
OH2N
ClO
OH
(B) 100 mg
Pharmaceutical impurities
136 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0073.05 Imp. D (EP): Methyl 4-(Acetylamino)-2-methoxybenzoate
ONH
O
O O
(A) 100 mg
MM 0073.01 Imp. E (EP): N,N-Diethylethane-1,2-diamine H2N
N(B) 100 mg
MM 0073.06 Imp. F (EP): 4-Amino-5-chloro-N-[2-(diethylamino)ethyl]-2-hydroxybenzamide
OHH2N
ClNH
ON
(A) 100 mg
MM 0073.07 Imp. G (EP): N'-(4-Amino-5-chloro-2-methoxybenzoyl)-N,N-diethylethane-1,2-diamine N-Oxide (Metoclopramide N-Oxide)
OH2N
ClNH
ONO
(A) 100 mg
MM 0073.08 Imp. H (EP): 4-(Acetylamino)-2-hydroxybenzoic Acid
OHNH
O
O OH
(A) 100 mg
MM 0073.09 Methyl 4-Amino-2-hydroxybenzoate
OHH2N
O
O (A) 100 mg
MM 0073.10 Methyl 4-(Acetylamino)-2-hydroxybenzoate
OHNH
O
O O
(A) 100 mg
Metoprolol Succinate MM 0279.00 Metoprolol Succinate
O
O
OHHN
2
O
HOOH
O
x
(A) 100 mg
MM 0027.04 Imp. A (EP): (2RS)-1-(Ethylamino)-3-[4-(2-methoxyethyl)-phenoxy]propan-2-ol
O
OOH H
N(A) 100 mg
MM 0027.01 Imp. B (EP): 4-(2-Methoxyethyl)phenol O
OH (A) 100 mg
MM 0027.24 Imp. C (EP) as Hydrochloride: 4-[(2RS)-2- Hydroxy-3-[(1-methylethyl)amino]propoxy]- benzaldehyde Hydrochloride
OOH H
N
Ox HCl
(A) 100 mg
MM 0027.06 Imp. D (EP): (2RS)-3-[4-(2-Methoxyethyl)phenoxy]propane-1,2-diol
O
OOH
OH(A) 100 mg
MM 0027.07 Imp. E (EP): (2RS)-1-[2-(2-Methoxyethyl)phenoxy]-3-[(1-methylethyl)amino]propan-2-ol O
OHHN
O
(A) 100 mg
MM 0027.08 Imp. F (EP): (2RS)-1-[(1-Methylethyl)amino]-3-phenoxypropan-2-olO
OHHN
(A) 100 mg
MM 0027.09 Imp. G (EP): 2-(4-Hydroxyphenyl)ethanol HO
OH (A) 100 mg
MM 0027.10 Imp. H (EP): (2RS)-1-[4-(2-Hydroxyethyl)phenoxy]-3-[(1-methylethyl)amino]propan-2-ol
HO
OOH H
N(A) 100 mg
MM 0027.11 (2RS)-1-(4-Ethenylphenoxy)-3-[(1-methylethyl)amino]- propan-2-ol O
OH HN
(A) 100 mg
MM 0027.12 Imp. J (EP): 1-[2-Hydroxy-3-[(1-methylethyl)amino]propoxy]-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol
O
O
OH
O
OHHN
(A) 50 mg
MM 0027.13 (2RS)-1-[4-[(EZ)-2-Methoxyethenyl]phenoxy]-3-[(1methylethyl)amino]propan-2-ol O
OH HN
O
(A) 100 mg
MM 0027.28 Imp. M (EP) as Dihydrochloride: 1,3-Bis[(1-methylethyl)amino]propan-2-ol Dihydrochloride
HN
OHHN x 2 HCl
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 137
Code Product Code Unit
MM 0027.16 Imp. N (EP): (2RS)-3-[(1-Methylethyl)amino]propane-1,2-diol HO
OH HN
(A) 100 mg
MM 0027.03 Imp. O (EP): 1,1'-[(1-Methylethyl)imino]bis- [3-[4-(2-methoxyethyl)phenoxy] propan-2-ol] O
OOH
N
O
OOH (A) 100 mg
Metoprolol Tartrate MM 0027.00 Metoprolol Tartrate
O
O
OHHN
2
O
HOOH
O
x
OH
OH
(A) 500 mg
MM 0027.04 Imp. A (EP): (2RS)-1-(Ethylamino)-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol
O
OOH H
N(A) 100 mg
MM 0027.01 Imp. B (EP): 4-(2-Methoxyethyl)phenol O
OH (A) 100 mg
MM 0027.24 Imp. C (EP) as Hydrochloride: 4-[(2RS)-2- Hydroxy-3-[(1-methylethyl)amino]propoxy]- benzaldehyde Hydrochloride
OOH H
N
Ox HCl
(A) 100 mg
MM 0027.06 Imp. D (EP): (2RS)-3-[4-(2-Methoxyethyl)phenoxy]propane-1,2-diol
O
OOH
OH(A) 100 mg
MM 0027.07 Imp. E (EP): (2RS)-1-[2-(2-Methoxyethyl)- phenoxy]-3-[(1-methylethyl)amino]propan-2-ol O
OHHN
O
(A) 100 mg
MM 0027.08 Imp. F (EP): (2RS)-1-[(1-Methylethyl)amino]- 3-phenoxypropan-2-ol O
OHHN
(A) 100 mg
MM 0027.09 Imp. G (EP): 2-(4-Hydroxyphenyl)ethanol HO
OH (A) 100 mg
MM 0027.10 Imp. H (EP): (2RS)-1-[4-(2-Hydroxyethyl)- phenoxy]-3-[(1-methylethyl)amino]propan-2-ol
HO
OOH H
N(A) 100 mg
MM 0027.11 (2RS)-1-(4-Ethenylphenoxy)-3-[(1-methylethyl)amino]propan-2-ol O
OH HN
(A) 100 mg
MM 0027.12 Imp. J (EP): 1-[2-Hydroxy-3-[(1-methylethyl)amino]propoxy]-3-[4- (2-methoxyethyl)phenoxy]propan-2-ol
O
O
OH
O
OHHN
(A) 50 mg
MM 0027.13 (2RS)-1-[4-[(EZ)-2-Methoxyethenyl]phenoxy]-3-[(1methylethyl)amino]propan-2-ol O
OH HN
O
(A) 100 mg
MM 0027.28 Imp. M (EP) as Dihydrochloride: 1,3-Bis[(1-methylethyl)amino]propan-2-ol Dihydrochloride
HN
OHHN x 2 HCl
(A) 100 mg
MM 0027.16 Imp. N (EP): (2RS)-3-[(1-Methylethyl)amino]propane-1,2-diol HO
OH HN
(A) 100 mg
MM 0027.03 Imp. O (EP): 1,1'-[(1-Methylethyl) imino]bis-[3-[4-(2-methoxyethyl) phenoxy]propan-2-ol] O
OOH
N
O
OOH (A) 100 mg
MM 0027.02 1-[4-(2-Methoxyethyl)phenoxy]-2,3-epoxypropane
O
OO (A) 100 mg
MM 0027.17 1-Chloro-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol
O
O ClOH (A) 100 mg
MM 0027.18 4,4'-(2-Hydroxy-1,3-propandiyldioxy)- bis[(2-methoxyethyl)benzene)]
O
O OOH
O
(A) 100 mg
MM 0027.22 3-Chloropropane-1,2-diol OH
OHCl
(B) 100 mg
Pharmaceutical impurities
138 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0027.26 1-[2-(2-Methoxyethyl)phenyoxy]-2,3-epoxypropane O
O O (C) 50 mg
Metronidazole MM 0012.00 Metronidazole
N
N
O2NOH (A) 500 mg
MM 0012.02 Imp. A (EP): 2-Methyl-4-nitroimidazole NH
NO2N (B) 100 mg
MM 0012.05 Imp. B (EP): 4-Nitroimidazole NH
NO2N (C) 100 mg
MM 0012.06 Imp. C (EP): 2-(4-Nitro-1H-imidazol-1-yl)ethanol N
N
OHO2N
(A) 100 mg
MM 0012.07 Imp. D (EP): 2-(5-Nitro-1H-imidazol-1-yl)ethanol N
N
OHO2N (A) 100 mg
MM 0012.01 Imp. E (EP): 2-(2-Methyl-4-nitro-1H-imidazol-1-yl)ethanol N
N
OHO2N
(A) 100 mg
MM 0012.09 Imp. G (EP): 2-(2-Methyl-5-nitro-1H- imidazol-1-yl)acetic Acid N
N
OHO2N
O
(A) 100 mg
MM 0012.04 1-(2-Hydroxyethyl)-2-hydroxymethyl-5-nitroimidazole (Hydroxymetronidazole) N
N
O2NOH
OH
(A) 100 mg
Metronidazole Benzoate MM 0278.00 Metronidazole Benzoate
N
N
O2NO
O
(A) 100 mg
MM 0012.00 Imp. A (EP): Metronidazole N
N
O2NOH
(A) 500 mg
MM 0012.02 Imp. B (EP): 2-Methyl-5-nitroimidazole (2-Methyl-4-nitroimidazole) NH
N
O2N (B) 100 mg
MM 0278.01 Imp. C (EP): Benzoic Acid OH
O (B) 100 mg
MM 0278.04 2-(2-Methyl-4-nitro-1H-imidazol-1-yl)ethyl Benzoate N
N
O
OO2N
(A) 100 mg
Mevastatin MM 0377.00 Mevastatin
O
O
OHO O
(A) 100 mg
Mexiletine Hydrochloride MM 0146.00 Mexiletine Hydrochloride
O
NH2
x HCl
(A) 500 mg
MM 0146.01 Imp. A (EP): 2,6-Dimethylphenol OH
(A) 100 mg
MM 0146.02 Imp. B (EP): 1-(2,6-Dimethylphenoxy)propan-2-one O
O (A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 139
Code Product Code Unit
Mianserin Hydrochloride MM 0147.00 Mianserin Hydrochloride
N
N
x HCl
(A) 100 mg
MM 0147.01 Imp. A (EP): [2-[(2RS)-4-Methyl-2-phenylpiperazin-1-yl] phenyl]methanol
N
N
OH
(A) 100 mg
MM 0147.04 Imp. C (EP): (2-Aminophenyl)methanol H2N
OH
(B) 100 mg
MM 0147.06 Mianserin N-Oxide
N
NO (D) 100 mg
Miconazole Nitrate MM 0281.00 Miconazole Nitrate
O
x HNO3
N
N
Cl
Cl
ClCl
(A) 500 mg
MM 0074.00 Miconazole
ON
N
Cl
Cl
ClCl
(A) 250 mg
MM 0281.01 Imp. A (EP): (1RS)-1-(2,4-Dichlorophenyl)-2-(1H-imidazol-1-yl)ethanol
HON
N
Cl
Cl (A) 100 mg
MM 0524.00 Imp. B (EP) as Nitrate: 1-[(2RS)-2-[(4-Chlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole Nitrate (Econazole Nitrate)
O
x HNO3
N
N
Cl
Cl
Cl
(A) 500 mg
MM 0281.03 Imp. C (EP) as Nitrate: (2RS)-2-[(2,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethanamine Nitrate
O
x HNO3
NH2
Cl
Cl
ClCl
(D) 100 mg
MM 0541.00 Imp. D (EP) as Nitrate: 1-[(2RS)-2-[(2,6-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)- ethyl]-1H-imidazole Nitrate (Isoconazole Nitrate)
O
x HNO3
N
N
Cl
Cl
Cl
Cl
(A) 100 mg
Pharmaceutical impurities
140 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0281.06 Imp. F (EP) as Nitrate: 1-[(2RS)-2-[(3,4-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole Nitrate
O
x HNO3
N
N
Cl
Cl
ClCl
(A) 100 mg
MM 0281.07 Imp. G (EP) as Nitrate: 1-[(2RS)-2-[(2,5-Dichlorobenzyl)oxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole Nitrate
O
x HNO3
N
N
Cl
Cl
Cl
Cl
(A) 100 mg
MM 0281.08 Imp. H (EP) as Nitrate: 1-[(2RS)-2-Benzyloxy-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole Nitrate
O
x HNO3
N
N
Cl
Cl (A) 100 mg
MM 0281.09 Imp. I (EP) as Nitrate: 1-[(2RS)-2-[(2-Chlorobenzyl)- oxy]-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole Nitrate
O
x HNO3
N
N
Cl
Cl
Cl
(A) 100 mg
MM 0281.10 1-(2,4-Dichlorobenzoylmethyl)imidazole
ON
N
Cl
Cl (A) 100 mg
Midazolam MM 0070.02 Imp. F (EP): 7-Chloro-5-(2-fluorophenyl)-1,3-
dihydro-2H-1,4-benzodiazepin-2-one (1-Des[(diethylamino)ethyl]flurazepam) N
HN
O
Cl
F
(A) 100 mg
Minoxidil MM 0521.00 Minoxidil
N
NN NH2
NH2
O
(A) 500 mg
MM 0521.01 Imp. A (EP): 6-Chloropyrimidine-2,4-diamine 3-Oxide N
NCl NH2
NH2
O
(A) 100 mg
MM 0521.02 Imp. B (EP): 6-Chloropyrimidine-2,4-diamine N
NCl NH2
NH2
(C) 100 mg
MM 0521.05 Imp. E (EP): 6-(Piperidin-1-yl)pyrimidine-2,4-diamine (Desoxyminoxidil)
N
NN NH2
NH2
(A) 100 mg
Mirtazapine MM 1005.01 Imp. E (EP): (2RS)-4-Methyl-1-(3-methyl-
pyridin-2-yl)-2-phenylpiperazine
N
N
N
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 141
Code Product Code Unit
MM 1005.02 Imp. A (EP): (14bRS)-2-Methyl-1,2,3,4,10- 14b-hexahydropyrazino[2,1-a]pyrido[2,3- c][2]benzazepine 2-Oxide
N
N
N
O(A) 100 mg
MM 1005.03 Imp. B (EP): [2-[(2RS)-4-Methyl-2-phenyl- piperazin-1-yl]pyridin-3-yl]methanol
N
N
NHO
(A) 100 mg
MM 1005.07 1-Methyl-3-phenylpiperazine
HN
N
(A) 100 mg
Moclobemide MM 0250.00 Moclobemide O
NH
Cl
NO (A) 100 mg
Modafinil New MM 0599.14 Imp. K (EP): [Oxybis(methanetriyl)]tetrabenzene
(Bis(diphenylmethyl) Ether)
O
(A) 50 mg
Molsidomine MM 0267.00 Molsidomine
ON
N
O NN
OO
+
-(A) 250 mg
MM 0267.02 Imp. A (EP) as Hydrochloride: 3-(Morpholin-4-yl)sydnonimine Hydrochloride (Linsidomine Hydrochloride) O
NN
O NHN +
-
x HCl
(A) 100 mg
MM 0267.03 Imp. B (EP): 4-Nitrosomorpholine N
O
N
O (A) 100 mg
MM 0267.01 Imp. C (EP): (2E)-(Morpholin-4-ylimino)acetonitrile N
O
NN (A) 100 mg
MM 0267.06 Imp. E (EP): Morpholine O
HN (A) 100 mg
Montelukast Sodium MM 0698.00 Montelukast Sodium
NCl SONa
O
HO
on request
Morphine Hydrochloride MM 0037.00 Morphine Hydrochloride Trihydrate
[Controlled Substance]
O OHHO
N
x HClx 3 H2O
(A) 250 mg
MM 0442.00 Imp. A (EP) as Phosphate Hemihydrate: Codeine Phosphate Hemihydrate[Controlled Substance]
O OHO
N
x ½ H2Ox H3PO4
(A) 100 mg
Pharmaceutical impurities
142 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0037.01 Imp. B (EP): 7,7',8,8'-Tetradehydro-4,5�:4',5'�-diepoxy-17,17'-dimethyl-2,2'-bimorphinanyl-3,3',6�,6'�-tetrol (Pseudomorphine; 2,2'-Bimorphine)
O OHHO
NOHO OH
N
(A) 100 mg
MM 0037.03 Imp. F (EP): (17S)-7,8-Didehydro-4,5�-epoxy-17-methylmorphinan-3,6�-diol 17-Oxide (Morphine N-Oxide) [Controlled Substance]
O OHHO
NO (A) 100 mg
MM 0037.02 7,7',8,8'-Tetradehydro-4,5a:4',5'a-diepoxy-3,3'-dimethoxy-17,17'-dimethyl-2,2'-bimorphinanyl-6a,6'a-diol(Codeine Dimer; Dimethyl Pseudomorphine)
O OHO
NOHO O
N
(A) 100 mg
Morphine Sulphate MM 0280.00 Morphine Hemisulphate Pentahemihydrate
[Controlled Substance]
O OHHO
N
x H2SO4
2
x 5 H2O
(A) 250 mg
MM 0442.00 Imp. A (EP) as Phosphate Hemihydrate: Codeine Phosphate Hemihydrate[Controlled Substance]
O OHO
N
x ½ H2Ox H3PO4
(A) 100 mg
MM 0037.01 Imp. B (EP): 7,7',8,8'-Tetradehydro-4,5�:4',5'�-diepoxy-17,17'-dimethyl-2,2'-bimorphinanyl-3,3',6�,6'�-tetrol (Pseudomorphine;2,2'-Bimorphine)
O OHHO
NOHO OH
N
(A) 100 mg
MM 0037.03 Imp. F (EP): (17S)-7,8-Didehydro-4,5�-epoxy- 17-methylmorphinan-3,6�-diol 17-Oxide (Morphine N-Oxide) [Controlled Substance]
O OHHO
NO (A) 100 mg
Moxifloxacin Hydrochloride MM 0885.00 Moxifloxacine Hydrochloride
NN
O
OH
OF
OHN
H
H
x HCl
(D) 100 mg
Moxonidine MM 1278.02 Imp. B (EP): N-(Imidazolidin-2-ylidene)-4,6-
dimethoxy-2-methylpyrimidin-5-amine (4-Methoxymoxonidine) N
N O
ON N
H
HN(A) 100 mg
Mycophenolate Mofetil MM 1001.00 Mycophenolate Mofetil
O
O OH
O
O
O
N
O
(D) 100 mg
MM 1001.05 Imp. E (EP): Methyl (4E)-6-(4-Hydroxy-6- methoxy-7-methyl-3-oxo-1,3-dihydroiso- benzofuran-5-yl)-4-methylhex-4-enoate O
O OH
O
O
O
(A) 100 mg
MM 1001.06 Imp. F (EP): (4E)-6-(4-Hydroxy-6-methoxy-7- methyl-3-oxo-1,3-dihydroisobenzofuran-5-yl)- 4-methylhex-4-enoic Acid (Mycophenolic Acid) O
O OH
O
OH
O
(A) 100 mg
MM 1001.07 Imp. G (EP): 2-(Morpholin-4-yl)ethyl (4E)-6-(4-Hydroxy-6-methoxy-7-methyl- 3-oxo-1,3-dihydroisobenzofuran-5-yl)- 4-methylhex-4-enoate N-Oxide
O
O OH
O
O
O
N
O
O (A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 143
Code Product Code Unit
MM 1001.08 Imp. H (EP): 7-Hydroxy-5-methoxy-4-methyl- 6-[2-[(2RS)-2-methyl-5-oxotetrahydrofuran-2- yl]ethyl]isobenzofuran-1(3H)-one O
O OH
O
OO
(A) 100 mg
Nabumetone MM 0153.00 Nabumetone
O
O (A) 500 mg
MM 0153.02 Imp. A (EP): 3-(6-Methoxynaphthalen-2-yl)-5-methylcyclohexanone
O
O (A) 100 mg
MM 0153.03 Imp. B (EP): (5RS)-5-(6-Methoxynaphthalen-2-yl)-3-methylcyclohex-2-enone
O
O (A) 100 mg
MM 0153.04 Imp. C (EP): (2RS)-4-(6-Methoxynaphthalen-2-yl)-butan-2-ol
O
OH (A) 100 mg
MM 0153.05 Imp. D (EP): (E)-4-(6-Methoxynaphthalen-2-yl)-but-3-en-2-one
O
O (A) 100 mg
New MM 0153.06 Imp. E (EP): 1,5-Bis(6-methoxynaphthalen- 2-yl)pentan-3-one
O
O
O
(A) 50 mg
MM 0153.07 Imp. F (EP): 6,6'-Dimethoxy-2,2'-binaphthalenyl
O
O (A) 100 mg
MM 0152.01 (6-Methoxy-2-naphthyl)acetic Acid ((6-Methoxynaphthalen-2-yl)acetic Acid, �-Demethylnaproxen)
O
OH
O
(A) 100 mg
Nadolol MM 0439.00 Nadolol
HOOH
OOH
HN
and enantiomers
on request
MM 0439.06 Imp. F (EP) as Hydrochloride: (2RS)-1-[(1,1- Dimethylethyl)amino]-3-(naphthalen-1-yloxy)- propan-2-ol Hydrochloride
O
OHHN x HCl
(A) 50 mg
MM 0439.07 Imp. G (EP) as Hydrochloride: (2RS)-1-[(1,1- Dimethylethyl)amino]-3-[(5,6,7,8-tetrahydro- naphtalen-1-yl)oxy]-propan-2-ol Hydrochloride
O
OHHN x HCl
(A) 50 mg
Nafcillin Sodium MM 0392.00 Nafcillin Sodium
N
S
ONaO
H
O
NHO
O
on request
MM 0392.02 Penilloic Acids of Nafcillin
HN
O
S
HN
OHO
O
(D) 100 mg
MM 0026.04 6-Aminopenicillanic Acid N
SH
O
H2N
OOH (B) 100 mg
MM 0392.04 2-Ethoxynaphthoic Acid OHO
O(B) 100 mg
Pharmaceutical impurities
144 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Naftidrofuryl Hydrogen Oxalate MM 0373.00 Naftidrofuryl Hydrogen Oxalate
O
O
O
N O OH
OHOx
(A) 500 mg
Naloxone Hydrochloride Dihydrate MM 0272.00 Naloxone Hydrochloride Dihydrate
O OHO
NOH x HCl
x 2 H2O
(A) 250 mg
Naltrexone MM 0233.00 Naltrexone Hydrochloride
O OHO
N
x HClHO
(A) 100 mg
Nandrolone MM 0660.00 Nandrolone
H
O
OH (A) 250 mg
MM 0660.01 19-Norandrost-4-ene-3,17-dione (Estr-4-ene-3,17-dione) H
O
O (A) 100 mg
Nandrolone Decanoate MM 0982.00 Nandrolone Decanoate
H
O
O
O (A) 100 mg
MM 0660.00 Imp. D (EP): 17�-Hydroxyestr-4-en-3-one (Nandrolone) H
O
OH (A) 250 mg
Naphazoline Hydrochloride MM 0075.00 Naphazoline Hydrochloride
N
HN
x HCl
(A) 500 mg
MM 0075.06 Imp. A (EP) as Hydrochloride: N-(2-Aminoethyl)-2-(naphthalen-1-yl)acetamide Hydrochloride (Naphthylacetylethylenediamine Hydrochloride)
O
NH
NH2
x HCl
(A) 100 mg
MM 0075.02 Imp. B (EP): (Naphthalen-1-yl)acetic Acid (1-Naphthylacetic Acid)
O
OH(B) 100 mg
MM 0075.04 Imp. C (EP): (Naphthalen-1-yl)acetonitrile (1-Naphthylacetonitrile)
N (B) 100 mg
MM 0075.05 Ethyl (1-Naphthyl)acetate O
O(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 145
Code Product Code Unit
MM 0075.07 (Naphthalen-1-y)lacetamide (1-Naphthylacetamide) O
NH2
(A) 100 mg
Naphazoline Nitrate MM 0286.00 Naphazoline Nitrate
N
HN
x HNO3
(A) 500 mg
MM 0075.06 Imp. A (EP) as Hydrochloride: N-(2-Aminoethyl)-2-(naphthalen-1-yl)acetamide Hydrochloride (Naphthylacetylethylenediamine Hydrochloride)
O
NH
NH2
x HCl
(A) 100 mg
MM 0075.02 Imp. B (EP): (Naphthalen-1-yl)acetic Acid (1-Naphthylacetic Acid)
O
OH(B) 100 mg
MM 0075.04 Imp. C (EP): (Naphthalen-1-yl)acetonitrile (1-Naphthylacetonitrile) N (B) 100 mg
MM 0075.05 Ethyl (1-Naphthyl)acetate O
O
(A) 100 mg
MM 0075.07 (Naphthalen-1-yl)acetamide (1-Naphthylacetamide)
O
NH2
(A) 100 mg
NaproxenMM 0152.00 Naproxen
O
OH
O
(A) 500 mg
MM 0152.06 Imp. A (EP): (2S)-2-(6-Hydroxynaphthalen-2-yl)- propanoic Acid (O-Demethylnaproxen)
HO
OH
O
(A) 100 mg
MM 0152.09 Imp. B (EP): (2S)-2-(5-Chloro-6-methoxy- naphthalen-2-yl)propanoic Acid (5-Chloronaproxen) O
OH
O
Cl
(A) 100 mg
MM 0152.10 Imp. C (EP): (2S)-2-(5-Bromo-6-methoxy- naphthalen-2-yl)propanoic Acid (5-Bromonaproxen) O
OH
O
Br
(A) 100 mg
MM 0152.11 Imp. D (EP): (2S)-2-(5-Iodo-6-methoxy- naphthalen-2-yl)propanoic Acid (5-Iodonaproxen) O
OH
O
I
(A) 100 mg
MM 0152.02 Imp. E (EP): Methyl (2S)-2-(6-Methoxy- naphthalen-2-yl)propanoate (Naproxen Methyl Ester) O
O
O
(A) 100 mg
MM 0152.12 Imp. F (EP): Ethyl (2S)-2-(6-Methoxy- naphthalen-2-yl)propanoate (Naproxen Ethyl Ester) O
O
O
(A) 100 mg
MM 0152.14 Imp. H (EP): 6-Methoxynaphthalen-2-ol (Hydroxynerolin) O
OH (A) 100 mg
MM 0152.01 Imp. I (EP):(6-Methoxynaphthalen-2-yl)acetic Acid (�-Demethylnaproxen) O
OH
O(A) 100 mg
MM 0152.18 Imp. J (EP): 2-Ethyl-6-methoxynaphthalene (Ethylnerolin) O
(A) 100 mg
Pharmaceutical impurities
146 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0152.16 Imp. K (EP): (1RS)-1-(6-Methoxynaphthalen-2-yl)ethanol
O
OH (A) 100 mg
MM 0152.07 Imp. L (EP): 1-(6-Methoxynaphthalen-2-yl)ethanone (Acetylnerolin)
O
O (B) 100 mg
MM 0152.08 Imp. M (EP): 2-Methoxynaphthalene (Nerolin) O
(B) 100 mg
MM 0152.17 Imp. N (EP): 2-Bromo-6-methoxynaphthalene O
Br (C) 100 mg
MM 0152.04 Naproxen Sodium
O
ONa
O
(A) 500 mg
MM 0152.15 2-Carboxy-6-methoxynaphthalene
O
OH
O (A) 100 mg
Nateglinide MM 0847.00 Nateglinide
NH
O OHO on request
New MM 0314.03 Imp. C (EP): Phenylalanine H2N
OH
O (B) 100 mg
Nevirapine Anhydrous MM 1146.01 Imp. A (EP): 11-Ethyl-4-methyl-5,11-dihydro-
6H-dipyrido [3,2-b:2',3'-e][1,4]diazepin-6-one
NH
NN N
O
(A) 100 mg
MM 1146.02 Imp. B (EP): 4-Methyl-5,11-dihydro-6H- dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one
NH
HNN N
O
(A) 100 mg
MM 1146.03 Imp. C (EP): 4-Methyl-11-propyl-5,11-dihydro- 6H-dipyrido[3,2-b:2',3'-e][1,4]diazepin-6-one
NH
NN N
O
(D) 100 mg
MM 1146.04 3-Amino-2-chloro-4-methylpyridine NCl
H2N
(A) 100 mg
Nicardipine Hydrochloride MM 0465.00 Nicardipine Hydrochloride H
N
O
O
O
ON
NO2
x HCl
(A) 250 mg
MM 0465.01 3-Methyl 5-[Methyl(phenylmethyl)amino]- ethyl 2,6-Dimethyl-4-(3-nitrophenyl)pyridine- 3,5-dicarboxylate Dihydrochloride
N
O
O
O
ON
NO2
x 2 HCl
on request
Nicergoline MM 0115.00 Nicergoline
N
O
O
NN
O
HBr (A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 147
Code Product Code Unit
MM 0115.02 Imp. A (EP): [(6aR,9R,10aS)-10a-Methoxy- 4,7-dimethyl-4,6,6a,7,8,9,10,10a-octahydro- indolo[4,3-fg]quinolin-9-yl]methyl 5-Chloro- pyridine-3-carboxylate
N
O
O
NN
O
HCl (D) 50 mg
MM 0115.04 Imp. C (EP): [(6aR,9R,10aS)-10a-Methoxy-4,7-dimethyl-4,6,6a,7,8,9,10,10a-octahydroindolo[4,3-fg]quinolin-9-yl]methanol (Methylmethoxylumilysergol)
N
OHN
O
H (D) 100 mg
MM 0115.06 Imp. D (EP): 5-Bromopyridine-3-carboxylic Acid
HO
O
N
Br (B) 100 mg
MM 0115.03 5-Debromonicergoline N
O
O
NN
O
H on request
Nicorandil MM 0924.00 Nicorandil
N
NH
O
ONO2
(A) 100 mg
Nicotinamide MM 0552.00 Nicotinamide
N NH2
O (A) 500 mg
MM 0552.01 Isonicotinamide
NNH2
O (A) 100 mg
Nicotine MM 0517.00 Nicotine
N N
(A) 500 mg
MM 0517.03 Imp. C (EP): (5S)-1-Methyl-5-(pyridin-3-yl)pyrrolidin-2-one (Cotinine) N N O
(A) 100 mg
MM 0517.01 Imp. G (EP): 3-[(2S)-Piperidin-2-yl]pyridine (Anabasine) N N
H
(A) 100 mg
Nicotinic Acid MM 0553.00 Nicotinic Acid
N OH
O (A) 500 mg
MM 0553.03 Imp. E (Pharmeuropa): Pyridine-4-carboxylic Acid (Isonicotinic Acid)
N
OH
O (A) 100 mg
MM 0549.00 Methyl Nicotinate N O
O (A) 500 mg
MM 0104.00 Benzyl Nicotinate N O
O (A) 500 mg
Nifedipine MM 0003.00 Nifedipine
O
O
O
O
HN
NO2
(A) 500 mg
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Thermal properties
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Viscosity
Electrical properties
Polymeric properties
Reference materials forphysical properties
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 149
Code Product Code Unit
MM 0003.02 Imp. A (EP): Dimethyl 2,6-Dimethyl-4-(2-nitrophenylpyridine-3,5-dicarboxylate (Nitrophenylpyridine Analogue of Nifedipine)
O
O
O
O
N
NO2
(A) 100 mg
MM 0003.01 Imp. B (EP): Dimethyl 2,6-Dimethyl-4-(2-nitrosophenylpyridine-3,5-dicarboxylate (Nitrosophenylpyridine Analogue of Nifedipine)
O
O
O
O
N
NO
(A) 100 mg
MM 0003.07 Imp. C (EP) as E/Z-Mixture: Methyl (E/Z)-2-(2-Nitrobenzylidene)-3-oxobutanoate
NO2
O
O
O
(A) 100 mg
MM 0003.08 Imp. D (EP): Methyl 3-Aminobut-2-enoate O
O
H2N (C) 100 mg
MM 0003.03 2-Nitrobenzaldehyde O
NO2
(B) 100 mg
Niflumic Acid MM 0850.00 Niflumic Acid
N
OH
O
NH
F
F F
(A) 250 mg
MM 0915.01 Imp. A (EP): 2-Chloropyridine-3-carboxylic Acid (2-Chloronicotinic Acid)
N
OH
O
Cl (A) 100 mg
MM 0850.05 Imp. B (EP): 2-Hydroxy-N-[3-(trifluoro- methyl)phenyl]pyridine-3-carboxamide H
NF
F F
O
N OH (A) 100 mg
MM 0161.06 Imp. C (EP): 3-(Trifluoromethyl)aniline
NH2
F
FF (B) 100 mg
MM 0850.01 Imp. F (EP): Methyl 2-[[3-(Trifluoromethyl)- phenyl]amino]pyridine-3-carboxylate (Niflumic Acid Methyl Ester)
N
O
O
NH
F
FF (A) 100 mg
Nifuroxazide MM 0574.00 Nifuroxazide
ON
HN
OH
O
O2N
(A) 500 mg
MM 0574.01 Imp. A (EP): 4-Hydroxybenzohydrazide (p-Hydroxybenzohydrazide) H2N
HN
OH
O
(C) 100 mg
MM 0431.00 Imp. B (EP): Methyl 4-Hydroxybenzoate (Methyl Parahydroxybenzoate) O
OH
O
(A) 500 mg
MM 0943.02 Imp. C (EP): (5-Nitrofuran-2-yl)methylidene Diacetate ((5-Nitrofuran-2-yl)methylene Diacetate)
OOO2N
O
O
O
(A) 100 mg
Pharmaceutical impurities
150 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Nifursol MM 0444.00 Nifursol OH
O2N
NO2
NH
ON O
NO2(A) 100 mg
MM 0444.01 5-Nitro-2-furfural O NO2
O (C) 100 mg
MM 0444.02 5-Nitrofurfural Hydrazone O NO2
NH2N (A) 100 mg
MM 0444.03 3,5-Dinitrosalicylic Acid Hydrazide OHO2N
NO2
NH
ONH2
(A) 100 mg
Nikethamide MM 0627.00 Nikethamide
N N
O on request
Nimesulide MM 0378.00 Nimesulide
OO2N
HN
SO O
(A) 250 mg
MM 0378.01 Imp. A (EP): N-(2,4-Dinitro-6-phenoxyphenyl)methanesulphonamide
OO2N
HN
SOO
NO2 (A) 100 mg
MM 0378.02 Imp. B (EP): N-(2-Phenoxyphenyl)methanesulphonamide
O
HN
SOO
(A) 100 mg
MM 0378.03 Imp. C (EP): 2-Phenoxyaniline
O
NH2 (A) 100 mg
MM 0378.04 Imp. D (EP): 4-Nitro-2-phenoxyaniline
O
NH2
O2N
(A) 100 mg
MM 0378.05 Imp. E (EP): N,N-Bis(methylsulphonyl)-2- phenoxyaniline
O
NS
SO
O
O O
(A) 100 mg
MM 0378.06 Imp. F (EP): N,N-Bis(methylsulphonyl)-4- nitro-2-phenoxyaniline
O
NS
S
O2NO O
OO (A) 100 mg
MM 0378.07 Imp. G (EP): 4-Nitro-2-phenoxyphenol
O
OH
O2N
(A) 50 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 151
Code Product Code Unit
Nimodipine MM 0416.00 Nimodipine H
N
O
OO
O
O
NO2
(A) 100 mg
MM 0416.01 Imp. A (EP): 2-Methoxyethyl 1-Methylethyl 2,6-Dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate
N
O
OO
O
O
NO2
(A) 100 mg
MM 0416.02 Imp. B (EP): Bis(1-methylethyl) 2,6-Dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
HN
O
O
O
O
NO2
(A) 100 mg
MM 0416.03 Imp. C (EP): Bis(2-methoxyethyl) 2,6-Dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
HN
O
OO
O
O
NO2
O
(A) 100 mg
Nitrazepam MM 0078.00 Nitrazepam
[Controlled Substance]N
HN
O
O2N
(A) 100 mg
MM 0078.02 Imp. A (EP): 3-Amino-6-nitro-4-phenylquinolin-2(1H)-one
O2N
HN
NH2
O (A) 100 mg
MM 0078.01 Imp. B (EP): (2-Amino-5-nitrophenyl)phenylmethanone (2-Amino-5-nitrobenzophenone) O2N
NH2
O
(B) 100 mg
MM 0078.03 Imp. C (EP): 2-Bromo-N-[4-nitro-2-(phenyl- carbonyl)phenyl]acetamide NH
O
OBr
O2N
(A) 50 mg
MM 0078.05 Imp. D (EP): 2-(1,3-Dioxo-1,3-dihydro-2H-isoindol-2-yl)-N-[4-nitro-2-(phenylcarbonyl)- phenyl]acetamide NH
O
ON
O
O
O2N
(A) 50 mg
MM 0078.07 7-Aminonitrazepam
N
HN
O
H2N
(A) 100 mg
Nitrendipine MM 0092.00 Nitrendipine H
N
NO2
O
O
O
O
(A) 500 mg
MM 0092.03 Imp. A (EP): Ethyl Methyl 2,6-Dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate (Photolysis Product)
N
NO2
O
O
O
O
(A) 100 mg
Pharmaceutical impurities
152 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0092.01 Imp. B (EP): Dimethyl 2,6-Dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
HN
NO2
O
O
O
O
(A) 100 mg
MM 0092.02 Imp. C (EP): Diethyl 2,6-Dimethyl-4-(3-nitrophenyl)-1,4-dihydropyridine-3,5-dicarboxylate
HN
NO2
O
O
O
O
(A) 100 mg
MM 0092.04 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylic Acid Methyl Ester
HN
NO2
OH
O
O
O
(A) 50 mg
MM 0092.05 1,4-Dihydro-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylic Acid Ethyl Ester
HN
NO2
OH
O
O
O
(A) 50 mg
Nitrofural MM 0943.00 Nitrofural OO2N
NHN NH2
O
(A) 500 mg
MM 0943.02 Imp. B (EP): (5-Nitrofuran-2-yl)methylene Diacetate
OO2NO
O
O
O
(A) 100 mg
Nitrofurantoin MM 0506.00 Nitrofurantoin
OO2N NN
HNO
O(A) 500 mg
Nizatidine MM 0220.00 Nizatidine
NO2
NH
NH
SN
S
N (A) 500 mg
MM 0220.01 Imp. A (EP): N,N‘-Dimethyl-2-nitroethene-1,1-diamine NO2
NH
NH
(A) 100 mg
MM 0220.09 Imp. B (EP): (EZ)-N-Methyl-1-methylsulphanyl)-2-nitroethen-1-amine NO2
S NH
(A) 100 mg
MM 0220.02 Imp. C (EP): (EZ)-N-[2-[[[2-[(Dimethylamino)methyl]thiazol-4-yl]methyl]sulphinyl]ethyl]-N‘-methyl-2-nitroethene-1,1-diamine
NO2
NH
NH
SN
S
N
O
(C) 50 mg
MM 0220.04 Imp. D (EP) as Dioxalate: 2-[[[2-[(Dimethyl- amino)methyl]thiazol-4-yl]methyl]sulphanyl]- ethanamine Dioxalate
NH2S
NS
N HO O
OHO
x 2
(A) 50 mg
MM 0220.10 Imp. G (EP): N,N'-Bis[2-[[[2-[(dimethylamino)- methyl]thiazol-4-yl]methyl]sulphanyl]ethyl]-2- nitroethene-1,1-diamine
NH
NH
SN
S
N
NO2
S SN
N (A) 50 mg
MM 0220.11 Imp. H (EP) as Hydrochloride: 2-(Dimethylamino)thioacetamide Hydrochloride
S
NH2N x HCl (A) 100 mg
MM 0086.07 Imp. K (EP): 3-(Methylamino)-5,6-dihydro-2H-1,4-thiazin-2-one Oxime N
S
NH
NOH (A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 153
Code Product Code Unit
Nonivamide MM 1033.00 Nonivamide
HO
ONH
O (A) 500 mg
MM 1033.01 4-(Aminomethyl)-2-methoxyphenol Hydrochloride (Vanillylamine Hydrochloride)
HO
ONH2 x HCl
(A) 100 mg
MM 1033.02 N-[(4-Hydroxy-3-methoxyphenyl)methyl]octanamide (N-Vanillyloctanamide)
HO
ONH
O (A) 100 mg
MM 1033.03 N-[(4-Hydroxy-3-methoxyphenyl)methyl]-decanamide (N-Vanillyldecanamide)
HO
ONH
O (A) 100 mg
MM 1033.04 N,O-Dinonanoylvanillylamine
O
ONH
O
O
(A) 100 mg
Noradrenaline Tartrate MM 0614.02 Imp. A (EP): Adrenaline (L-Adrenaline)
HO
HO
HN
OH (A) 500 mg
MM 0384.00 Imp. C (EP) as Hydrochloride: Dopamine Hydrochloride HO
HO
NH2
x HCl(A) 500 mg
Norethisterone MM 0218.00 Norethisterone
O
OH (A) 250 mg
MM 0218.04 Imp. A (EP): 17-Hydroxy-19-nor-17�-pregna-4,6-dien-20-yn-3-one(6,7-Didehydronorethisterone)
O
OH (D) 100 mg
MM 0660.01 Imp. B (EP): Estr-4-ene-3,17-dione (Norandrostenedione)
O
O (A) 100 mg
MM 0218.01 Imp. H (EP): 6�,17-Dihydroxy-19-nor-17�-pregn-4-en-20-yn-3-one(6�-Hydroxynorethisterone)
O
OH
OH
(D) 100 mg
MM 0218.02 6�-Hydroxynorethisterone
O
OH
OH
(D) 50 mg
MM 0218.03 6-Ketonorethisterone
O
OH
O
(D) 100 mg
Norethisterone Acetate MM 0219.00 Norethisterone Acetate
O
O
O (A) 100 mg
MM 0218.00 Imp. A (EP): Norethisterone
O
OH (A) 250 mg
Pharmaceutical impurities
154 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0219.10 Imp. B (EP): 3-Oxo-19-nor-17�-pregn-5(10)-en-20-yn-17-yl Acetate
O
O
O on request
MM 0219.01 Imp. F (EP): 6�-Hydroxy-3-oxo-19-nor-17�-pregn-4-en-20-yn-17-yl Acetate (6�-Hydroxynorethisterone Acetate)
O
O
O
OH
(D) 100 mg
MM 0219.03 Imp. G (EP): 3,6-Dioxo-19-nor-17�-pregn-4-en-20-yn-17-yl Acetate (6-Ketonorethisterone Acetate)
O
O
O
O
(D) 100 mg
MM 0219.02 6�-Hydroxynorethisterone Acetate
O
O
O
OH
(D) 50 mg
MM 0219.04 6,7-Didehydronorethisterone Acetate
O
O
O (D) 100 mg
Norfenefrine Hydrochloride MM 0973.00 Norfenefrine Hydrochloride
HO
OH
NH2 x HCl(A) 500 mg
Norfloxacin MM 0350.00 Norfloxacin
N N
OF
OH
O
HN (A) 250 mg
MM 0350.01 Imp. A (EP): 7-Chloro-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid NCl
O
OH
O
F
(A) 100 mg
MM 0350.03 Imp. D (EP): 1-Ethyl-6-fluoro-7-(piperazin-1-yl)quinolin-4(1H)-one NN
O
HN
F
(D) 100 mg
MM 0350.04 Imp. G (EP): 1-Ethyl-6-fluoro-7-(4-formyl-piperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic Acid NN
O
OH
O
N
F
O (D) 100 mg
Nortriptyline Hydrochloride MM 0079.00 Nortriptyline Hydrochloride
x HCl
NH
(A) 500 mg
MM 0062.01 Imp. A (EP): 10,11-Dihydro-5H-dibenzo[a,d][7]annulen-5-one (Dibenzosuberone)
O
(B) 100 mg
MM 0079.01 Imp. B (EP) as Hydrochloride: 3-(5H-Dibenzo- [a,d][7]annulen-5-ylidene)-N-methylpropan-1- amine Hydrochloride (Norcyclobenzaprine Hydrochloride)
NH x HCl
(A) 50 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 155
Code Product Code Unit
MM 0062.03 Imp. D (EP): 5-[3-(Dimethyl- amino)propyl]-10,11-dihydro-5H-dibenzo- [a,d][7]annulen-5-ol OH
N (A) 100 mg
MM 0062.02 Imp. E (EP) as Hydrochloride: 3-(5H-Dibenzo[a,d][7]annulen-5-ylidene)-N,N-dimethyl- propan-1-amine Hydrochloride (Cyclobenzaprine Hydrochloride)
N x HCl
(A) 100 mg
MM 0062.00 Imp. F (EP) as Hydrochloride: Amitriptyline Hydrochloride
N x HCl
(A) 500 mg
MM 0062.12 Imp. J (EP) as Hydrochloride: [3-(10,11- Dihydro-5H-dibenzo[a,d][7]annulen- 5-ylidene)propyl]-dimethylamine Oxide Hydrochloride (Amitriptyline N-Oxide Hydrochloride)
N x HCl
O(B) 10 mg
Nucleosides New MM 1316.01 Cytidine
O
OH
HO N
N
O
NH2
OH
(A) 100 mg
New MM 1316.02 2'-Deoxycytidine
O
OH
HO N
N
O
NH2 (A) 100 mg
Ofloxacin MM 0228.00 Ofloxacin
NO
N
OF
N
OH
O
(A) 500 mg
MM 0228.04 Imp. A (EP): (RS)-9,10-Difluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid (FPA) N
O
F
OF
OH
O
(A) 100 mg
MM 0228.05 Imp. B (EP): (RS)-9-Fluoro-3-methyl-10-(4- methylpiperazin-1-yl)-2,3-dihydro-7H-pyrido- [1,2,3-de]-1,4-benzoxazin-7-one
N
O
N
O
F
N (A) 100 mg
MM 0228.08 Imp. E (EP): (RS)-9-Fluoro-3-methyl-7-oxo-10-(piperazin-1-yl)-2,3-dihydro-7H-pyrido[1,2,3-de]-1,4-benzoxazine-6-carboxylic Acid
N
O
N
O
F
HN
OH
O
(A) 100 mg
MM 0228.10 Imp. F (EP) as Hydrochloride: 4-[(RS)-6-Carboxy-9-fluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de]-1,4-benzoxazine-10-yl]-1-methylpiperazine 1-Oxide Hydrochloride (Ofloxacin N-Oxide Hydrochloride)
NO
N
O
F
N
OH
O
O
x HCl
(A) 100 mg
Olanzapine MM 0329.07 Imp. C (Pharmeuropa): 1-(Chloromethyl)-1-
methyl-4-(2-methyl-10H-thieno[2,3-b][1,5]- benzodiazepin-4-yl)piperazin-1-ium Chloride (Olanzapine-N-Chloromethyl Chloride)
N
N+
N
HN
S
Cl
Cl-
(A) 100 mg
Pharmaceutical impurities
156 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0329.08 Imp. A (Pharmeuropa): 5-Methyl-2-[(2-nitro- phenyl)amino]thiophene-3-carbonitrile
HN
S
N
O2N
(A) 50 mg
MM 0329.02 Imp. B (Pharmeuropa): 2-Methyl-5,10-dihydro- 4H-thieno[2,3-b][1,5]benzodiazepin-4-one (Olanzapine Lactame)
OHN
HN
S
(A) 50 mg
Omeprazole MM 0095.00 Omeprazole
N
O
SO
HN
NO
(A) 500 mg
MM 0095.03 Imp. A (EP): 5-Methoxy-1H-benzimidazole-2-thiol SH
HN
NO
(A) 100 mg
MM 0095.04 Imp. B (EP): 2-[(RS)-[(3,5-Dimethylpyridin-2-yl) methyl]sulphinyl]-5-methoxy-1H-benzimidazole
NSO
HN
NO
(A) 100 mg
MM 0095.06 Imp. C (EP): 5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphanyl]-1H-benzimidazole (Ufiprazole)
N
O
S
HN
NO
(A) 100 mg
MM 0095.05 Imp. D (EP): 5-Methoxy-2-[[(4-methoxy-3,5-dimethylpyridin-2-yl) methyl]sulphonyl]-1H-benzimidazole (Omeprazole Sulphone) N
O
S
HN
NOO
O
(A) 100 mg
MM 0095.07 Imp. E (EP): 4-Methoxy-2-[[(RS)-(5-methoxy-1H-benzimidazol-2-yl)sulphinyl]methyl]-3,5-dimethylpyridine 1-Oxide (Omeprazole N-Oxide)
N
OS
O
NH
N
O
O
(A) 100 mg
MM 0095.01 Imp. F (EP): 8-Methoxy-1,3-dimethyl-12-thioxopyrido[1',2':3,4]imidazo[1,2-a]-benzimidazol-2(12H)-one N
N
N
S
OO
(D) 50 mg
MM 0095.02 Imp. G (EP): 9-Methoxy-1,3-dimethyl-12-thioxopyrido[1',2':3,4]imidazo[1,2-a]-benzimidazol-2(12H)-one N
N
N
S
O
O (D) 50 mg
MM 0095.15 Imp. H (EP): 2-[(RS)-[(4-Chloro-3,5-dimethylpyridin-2-yl)methyl]sulfinyl]-5-methoxy-1H-benzimidazole
N
S
O
NH
N
O
Cl
(D) 100 mg
MM 0095.16 Imp. I (EP): 4-Methoxy-2-[[(5-methoxy-1H-benzimidazol-2-yl)sulphonyl]methyl]-3,5-dimethylpyridine 1-Oxide (Omeprazole Sulphone N-Oxide)
N
OS
NH
N
O
OO O
(A) 100 mg
MM 0095.08 5-Methoxy-2-[[(3,5-dimethylpyridin-2-yl)methyl]sulphanyl]-1H-benzimidazole
N
S
NH
N
O (A) 100 mg
MM 0095.19 5-Methoxy-2-[[(4-chloro-3,5-dimethylpyridin-2-yl) methyl]sulphanyl]-1H-benzimidazole
N
ClS
NH
N
O (D) 100 mg
MM 0095.20 5-Methoxy-1,3-dihydrobenzimidazol-2-one
O
NH
NH
O (A) 100 mg
MM 0095.23 2-[[(4-Methoxy-3,5-dimethylpyridin-2-yl)methyl]sulphinyl]-1H-benzimidazole
N
OS
O
NH
N
(A) 100 mg
MM 0095.24 5-Methoxy-2-(4-methoxy-3,5-dimethylpyridin-2-yl)-1H-benzimidazole NH
N
O
N
O
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 157
Code Product Code Unit
Ondansetron Hydrochloride Dihydrate MM 0252.00 Ondansetron Hydrochloride Dihydrate
N
O
N
N x HClx 2 H2O
on request
MM 0252.09 Ondansetron N
O
N
Non request
MM 0252.03 Imp. A (EP): (3RS)-3-(Dimethylamino)methyl-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one
N
O
N
(A) 100 mg
MM 0252.02 Imp. B (EP): 6,6'-Methylene bis[(3RS)-9-methyl-3-[(2-methyl-1H-imidazol-1-yl)methyl]-1,2,3,9-tetrahydro-4H-carbazol-4-one]
N N
N NN N
OO
(D) 50 mg
MM 0252.01 Imp. C (EP): 9-Methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one N
O
(A) 100 mg
MM 0252.04 Imp. D (EP): 9-Methyl-3-methylene-1,2,3,9-tetrahydro-4H-carbazol-4-one
N
O
(A) 100 mg
MM 0015.02 Imp. E (EP): 1H-Imidazole (Imidazole) N
NH
(B) 100 mg
MM 0252.06 Imp. F (EP): 2-Methyl-1H-imidazole N
NH
(B) 100 mg
MM 0252.07 Imp. G (EP): (3RS)-3-[(1H-Imidazol-1-yl)methyl]-9-methyl-1,2,3,9-tetrahydro-4H-carbazol-4-one (C-Demethylondansetron)
N
O
N
N(A) 100 mg
MM 0252.08 Imp. H (EP): (3RS)-3-[(2-Methyl-1H-imidazol-1-yl)methyl]-1,2,3,9-tetrahydro-4H-carbazol-4-one (N-Demethylondansetron)
HN
O
N
N(A) 100 mg
Opipramol Dihydrochloride MM 0422.01 5-(3-Piperazin-1-yl-propyl)-5H-dibenzo[b,f]azepine
Dihydrochloride N
NNH
x 2 HCl
(A) 100 mg
Ornidazole MM 0948.00 Ornidazole
N
N
O2N
Cl
OH
(A) 500 mg
MM 0012.02 2-Methyl-4-nitroimidazole NH
N
O2N (B) 100 mg
MM 0948.02 3-(2-Methyl-5-nitro-1H-imidazol-1-yl)propane-1,2-diol N
N
O2N
OHOH
(A) 100 mg
MM 0948.03 3-(2-Methyl-5-nitro-1H-imidazol-1-yl)-1,2-epoxypropane N
N
O2N
O
(A) 100 mg
MM 0948.04 1-(3-Chloro-2-hydroxypropyl)-2-methyl-4-nitroimidazole N
N
Cl
OHO2N
(A) 100 mg
Orphenadrine Hydrochloride MM 0801.00 Orphenadrine Hydrochloride
ON
x HCl
(A) 500 mg
Pharmaceutical impurities
158 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0801.01 Imp. A (EP): (RS)-(2-Methylphenyl)phenylmethanol (2-Methylbenzhydrol)
OH
(A) 100 mg
MM 0801.02 Imp. B (EP): (2-Methylphenyl)phenylmethanone (2-Methylbenzophenone)
O
(A) 100 mg
MM 0801.03 Imp. C (EP) as Hydrochloride: (RS)-2-[(2-Methyl- phenyl)phenylmethoxy]ethanamine Hydrochloride
ONH2
x HCl
(A) 50 mg
MM 0490.00 Imp. D (EP) as Hydrochloride: Diphenhydramine Hydrochloride
ON
x HCl
(A) 500 mg
MM 0801.05 Imp. E (EP) as Hydrochloride: (RS)-N,N-Dimethyl-2-[(3-methylphenyl)phenylmethoxy]ethanamine Hydrochloride (meta-Methylbenzyl Isomer Hydrochloride)
ON x HCl
(A) 100 mg
MM 0490.04 Imp. F (EP) as Hydrochloride: (RS)-N,N- Dimethyl-2-[(4-methylphenyl)phenylmethoxy] ethanamine Hydrochloride (para-Methylbenzyl Isomer Hydrochloride; 4-Methyldiphenhydramine Hydrochloride)
ON
x HCl
(A) 100 mg
MM 0801.07 N-Desmethylorphenadrine Hydrochloride
O
HN
x HCl
(A) 100 mg
Oxacillin Sodium MM 0686.00 Oxacillin Sodium Monohydrate
ON N
H
O N
S
O
OONa
H
x H2O
(A) 250 mg
MM 0026.04 Imp. A (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl- 7-oxo-4-thia-1-azabicyclo[3.2.0]heptane-2- carboxylic Acid (6-Aminopenicillanic Acid) N
S
O
OOH
HH2N
(B) 100 mg
MM 0682.00 Imp. E (EP) as Sodium Salt Monohydrate: Cloxacillin Sodium Monohydrate
N
S
O
OONa
H
x H2OHN
O
NO
Cl (A) 500 mg
Oxalic Acid Dihydrate MM 0928.00 Oxalic Acid Dihydrate
OHO
O OHx 2 H2O
(A) 500 mg
MM 0928.01 Oxalic Acid
OHO
O OH (A) 500 mg
Oxaliplatin MM 0928.00 Imp. A (EP) as Dihydrate: Ethanedioic Acid
Dihydrate (Oxalic Acid Dihydrate) OHO
O OHx 2 H2O
(A) 500 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 159
Code Product Code Unit
Oxazepam MM 0080.00 Oxazepam
[Controlled Substance] N
HN
O
ClOH
(D) 100 mg
MM 0028.03 Imp. D (EP): (2-Amino-5-chlorophenyl)phenylmethanone (2-Amino-5-chlorobenzophenone) Cl
NH2
O
(B) 100 mg
MM 0028.02 Imp. E (EP): 7-Chloro-5-phenyl-1,3-dihydro- 2H-1,4-benzodiazepin-2-one 4-Oxide (Demoxepam) N
HN
O
ClO
(A) 100 mg
MM 0080.03 6-Chloro-4-phenyl-3,4-dihydroquinazoline-2-carboxylic Acid
Cl
N
NH
O
OH
(A) 100 mg
Oxcarbazepine MM 0076.17 Oxcarbazepine
N
O NH2
O (A) 100 mg
MM 0076.10 10-Hydroxy-10,11-dihydrocarbamazepine
N
O NH2
HO (A) 100 mg
Oxeladin Hydrogen Citrate MM 0547.00 Oxeladin Hydrogen Citrate
OO
N
O
x
OHO
OHO
OHOH
O
(A) 500 mg
MM 0547.02 Imp. A (EP): 2-[2-(Diethylamino)ethoxy]ethanol HOO
N (A) 100 mg
MM 0547.01 Oxeladin N-Oxide O
ON
O
O
(B) 10 mg
Oxfendazole MM 0518.02 Imp. B (EP): Methyl [5-(Phenylsulphonyl)-
1H-benzimidazol-2-yl]carbamate (Fenbendazole Sulphone) S N
HN
NHO
O
O O
(A) 100 mg
Oxolinic Acid MM 0898.00 Oxolinic Acid
O
O
N
OH
OO
(A) 250 mg
Oxomemazine MM 0957.00 Oxomemazine
S
N
N
O O
(A) 100 mg
Pharmaceutical impurities
160 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0958.00 Trimeprazine Tartrate
HO
OH
OH
OH
O
O
N
S
N
x
2
(A) 500 mg
MM 0958.02 Trimeprazine Sulphoxide Hydrochloride
S
N
N
O
x HCl
(A) 100 mg
MM 0958.04 Oxomemazine N-Oxide Hydrochloride (Trimeprazine Sulphone N-Oxide Hydrochloride)
S
N
NO
OO
x HCl
(A) 100 mg
Oxprenolol Hydrochloride MM 0129.00 Oxprenolol Hydrochloride
O
OOH H
Nx HCl
(A) 500 mg
New MM 0129.01 1-(2-Hydroxyphenoxy)-3-(isopropylamino)-2-propanol Hydrochloride
OH
O
OHHN
x HCl
(A) 50 mg
Oxybuprocaine Hydrochloride MM 0543.00 Oxybuprocaine Hydrochloride
O
O
H2N
O
N
x HCl
(A) 500 mg
MM 0094.03 Imp. A (EP): 4-Aminobenzoic Acid OH
O
H2N
(B) 100 mg
MM 0543.02 Imp. B (EP): 4-Amino-3-butoxybenzoic Acid OH
O
H2N
O
(A) 100 mg
MM 0543.03 Imp. C (EP): 4-Amino-3-hydroxybenzoic Acid OH
O
H2NOH
(A) 100 mg
MM 0543.05 Oxybuprocaine N-Oxide Dihydrochloride O
O
H2N
O
N
x 2 HClO
(A) 100 mg
Oxybutynin Hydrochloride MM 0047.00 Oxybutynin Hydrochloride
ON
O
x HClHO
(A) 250 mg
MM 0047.06 Imp. B (EP): 4-(Diethylamino)but-2-ynyl 2-Hydroxy-2,2-diphenylacetate (Diphenyl analogue of Oxybutynin) O
N
O
HO
(A) 100 mg
MM 0047.04 Imp. C (EP) as Hydrochloride: 4-(Ethylmethylamino)but-2-ynyl (RS)-2-Cyclohexyl-2-hydroxy-2-phenylacetate Hydrochloride (Methylethyl analogue of Oxybutynin Hydrochloride)
ON
O
x HClHO
(D) 100 mg
MM 0047.01 Imp. D (EP): (RS)-2-Cyclohexyl-2-hydroxy-2-phenylacetic Acid (Phenylcyclohexylglycolic Acid)
OH
O
HO
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 161
Code Product Code Unit
MM 0047.07 Imp. E (EP): 4-(Ethylpropylamino)but-2-ynyl (RS)-2-Cyclohexyl-2-hydroxy-2-phenylacetate (Ethylpropyl analogue of Oxybutynin) O
N
O
HO
(A) 100 mg
MM 0047.02 Methyl (RS)-2-Cyclohexyl-2-hydroxy-2- phenylacetate (Phenylcyclohexylglycolic Acid Methyl Ester)
O
O
OH
(A) 100 mg
MM 0047.03 4-Diethylaminobut-2-yn-1-ol NHO
(A) 100 mg
MM 0047.11 Desethyloxybutynin Hydrochloride
ONH
O
HOx HCl
(D) 100 mg
MM 0047.50 Propargyl (RS)-2-Cyclohexyl-2-hydroxy-2-phenylacetate (Phenylcyclohexylglycolic Acid Propargyl Ester)
O
O
HO
(B) 10 mg
Oxycodone Hydrochloride MM 0672.00 Oxycodone Hydrochloride
[Controlled Substance]
O OO
N
HO x HCl
(A) 100 mg
MM 0672.03 Imp. C (EP) as Hydrochloride: 4,5�-Epoxy-14-hydroxy-3-methoxymorphinan-6-one Hydrochloride (Noroxycodone Hydrochloride)
O OO
HN
HO x HCl
(D) 50 mg
MM 0672.05 4,5�-Epoxy-3-methoxy-17-methylmorphinan-6�,14-diol Hydrochloride(6�-Oxycodol Hydrochloride) [Controlled Substance]
O OHO
N
HO x HCl
on request
MM 0672.06 Oxycodone N-Oxide
O OO
N
HO
O (D) 50 mg
Oxymetazoline Hydrochloride MM 0177.00 Oxymetazoline Hydrochloride
HN
NHOx HCl
(A) 250 mg
MM 0177.01 Imp. A (EP) as Hydrochloride: N-(2-Aminoethyl)-2-[4-(1,1-dimethylethyl)-3-hydroxy-2,6-dimethylphenyl)]acetamide Hydrochloride
HOHN
ONH2 x HCl
(A) 100 mg
MM 0089.00 Imp. B (EP) as Hydrochloride: Xylometazoline Hydrochloride x HCl
NH
N(A) 500 mg
MM 0177.07 Imp. C (EP): 2-[4-(1,1-Dimethylethyl)-3- hydroxy-2,6-dimethylphenyl]acetamide
OH
NH2
O
(A) 100 mg
MM 0177.04 Imp. D (EP): [4-(1,1-Dimethylethyl)-3-hydroxy- 2,6-dimethylphenyl]acetic Acid
OH
OH
O
(A) 100 mg
MM 0177.05 Imp. E (EP): [4-(1,1-Dimethylethyl)-3-hydroxy- 2,6-dimethylphenyl]acetonitrile
OH
N
(D) 100 mg
Pharmaceutical impurities
162 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Oxyphenbutazone MM 0933.00 Oxyphenbutazone Monohydrate
NN
O
O
OH
x H2O
(A) 250 mg
Oxytetracycline Hydrochloride MM 0554.00 Oxytetracycline Hydrochloride OH O OH O
NH2
O
OH
OH
NOHHO
HH x HCl
(A) 500 mg
MM 0452.00 Imp. B (EP) as Hydrochloride: Tetracycline Hydrochloride OH O OH O
NH2
O
OH
OH
N
HH x HCl
HO
(A) 500 mg
Pantoprazole Sodium Sesquihydrate MM 0099.00 Pantoprazole Sodium
N
O
OS
O
NNa
N
O
FF
(D) 100 mg
MM 0099.01 Pantoprazole
N
O
OS
O
NH
N
O
FF
(D) 100 mg
MM 0099.02 Imp. A (EP): 5-(Difluoromethoxy)-2-[[(3,4-dimethoxypyridin-2-yl) methyl]sulphonyl]-1H-benzimidazole (Pantoprazole Sulphone)
S
NH
N
O
FF O
O
N
O
O
(A) 100 mg
MM 0099.03 Imp. B (EP): 5-(Difluoromethoxy)-2-[[(3,4- dimethoxypyridin-2-yl)methyl]sulphanyl]- 1H-benzimidazole
N
O
OS
NH
N
O
FF
(A) 100 mg
MM 0099.04 Imp. C (EP): 5-(Difluoromethoxy)-1H-benzimidazole-2-thiol
SH
NH
N
O
FF
(A) 100 mg
MM 0099.11 Mixture of Imp. D and F (EP): 5- and 6-(Di- fluoromethoxy)-2-[(RS)-[(3,4-dimethoxypyridin- 2-yl)methyl]sulphinyl]-1-methyl-1H-benzimidazole
N
O
OS
O
N
N
O
FF
N
O
OS
O
N
N
OF
F +
(D) 100 mg
MM 0099.05 2-Chloromethyl-3,4-dimethoxypyridine Hydrochloride Cl
N
OO
x HCl
(A) 100 mg
MM 0099.06 Pantoprazole N-Oxide
N
O
OS
O
NH
N
O
FF
O
(D) 100 mg
MM 0099.07 Pantoprazole Sulphone N-Oxide
N
OO
S
NH
N
O
FF
OO O
(A) 100 mg
Paracetamol MM 0042.00 Paracetamol H
N
OHO
(A) 500 mg
MM 0042.08 Imp. A (EP): N-(2-Hydroxyphenyl)acetamide (2-Acetamidophenol)
OH
O
HN
(B) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 163
Code Product Code Unit
MM 0042.05 Imp. B (EP): N-(4-Hydroxyphenyl)propanamide (N-Propionyl-4-aminophenol)
HN
OHO
(A) 100 mg
MM 0042.09 Imp. C (EP): N-(3-Chloro-4-hydroxyphenyl)acetamide (3-Chloro-4-hydroxyacetanilide)
HO
HN
O
Cl (A) 100 mg
MM 0042.10 Imp. D (EP): N-Phenylacetamide (Acetanilide) HN
O
(B) 100 mg
MM 0042.11 Imp. E (EP): 1-(4-Hydroxyphenyl)ethanone (4-Hydroxyacetophenone)
HO
O (B) 100 mg
MM 0042.03 Imp. F (EP): 4-Nitrophenol NO2
HO
(B) 100 mg
MM 0042.12 Imp. G (EP): 1-(4-Hydroxyphenyl)ethanone Oxime (4-Hydroxyacetophenone Oxime)
NHO
HO
(A) 100 mg
MM 0042.04 Imp. H (EP): 4-(Acetylamino)phenyl Acetate (N,O-Diacetyl-4-aminophenol)
HN
OO
O(A) 100 mg
MM 0042.13 Imp. I (EP): 1-(2-Hydroxyphenyl)ethanone (2-Hydroxyacetophenone)
O
OH
(B) 100 mg
MM 0042.02 Imp. J (EP): N-(4-Chlorophenyl)acetamide (4-Chloroacetanilide)
HN
OCl
(B) 100 mg
MM 0042.01 Imp. K (EP): 4-Aminophenol NH2
HO
(B) 100 mg
MM 0042.07 3-Aminophenol NH2HO (B) 100 mg
Paroxetine Hydrochloride Anhydrous MM 1032.02 Imp. B (EP): 1,3-Benzodioxol-5-ol (Sesamol) O
O
OH (A) 100 mg
MM 1032.07 Imp. G (EP) as Hydrochloride: 4-(4-Fluorophenyl)- 1-methyl-1,2,3,6-tetrahydropyridine Hydrochloride x HCl
N
F (A) 100 mg
MM 1032.12 [(3S,4R)-4-(4-Fluorophenyl)-1-methylpiperidin-3-yl]methanol
HO N
F (A) 100 mg
Pentetrazol MM 0692.00 Pentetrazol N
N NN
(A) 500 mg
Pentoxifylline MM 0761.00 Pentoxifylline
N
N N
N
O
OO (A) 500 mg
MM 0577.00 Imp. A (EP): Theobromine HN
N N
N
O
O (A) 500 mg
MM 0176.03 Imp. B (EP): 3-Methyl-3,7-dihydro-1H-purine- 2,6-dione (3-Methylxanthine) HN
N N
HN
O
O (A) 100 mg
MM 0176.00 Imp. C (EP): Theophylline N
N N
HN
O
O (A) 500 mg
Pharmaceutical impurities
164 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0494.00 Imp. F (EP): Caffeine N
N N
N
O
O (A) 500 mg
Pentoxyverine Hydrogen Citrate MM 1268.01 Imp. A (EP): 1-Phenylcyclopentanecarboxylic Acid
OH
O (A) 100 mg
Peppermint Oil MM 0388.00 (-)-Menthol (Levomenthol)
OH
(A) 500 mg
MM 0163.12 (+)-(R)-Pulegone
O
(A) 100 mg
Perazine Dimaleate MM 0815.00 Perazine Dimaleate
S
N
NN O
HO
HO
O
x 2
(A) 100 mg
Perazine Dimalonate MM 0157.00 Perazine Dimalonate
S
N
NN
OOH
OHO
x 2
on request
MM 0157.01 Perazine Sulphoxide
S
N
NN
O
(A) 100 mg
MM 0157.02 Phenothiazine
S
HN (B) 100 mg
MM 0157.03 1-(3-Chloropropyl)-4-methylpiperazine N
NCl
on request
Perphenazine MM 0826.00 Perphenazine
S
N
Cl
N
NOH
(A) 100 mg
MM 0826.01 Imp. A (EP): 2-[4-[3-(2-Chloro-5-oxido-10H-phenothiazin-10-yl)propyl]piperazin-1-yl]- ethanol (Perphenazine Sulphoxide) S
N
Cl
N
NOHO
(A) 100 mg
New MM 0826.02 Imp. B (EP): 2-[4-[3-(10H-Phenothiazin-10- yl)propyl]piperazin-1-yl]ethanol
SN N
NOH
(A) 50 mg
Phenacetin MM 0551.00 Phenacetin
O
HN
O
(A) 100 mg
MM 0042.00 Paracetamol HN
OHO
(A) 500 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 165
Code Product Code Unit
MM 0042.01 4-Aminophenol NH2
HO
(B) 100 mg
Phenethyl Alcohol MM 0953.00 Phenylethyl Alcohol OH (A) 500 mg
Pheniramine Maleate MM 0059.00 Pheniramine Maleate O
OH
O
OHx
NN
(A) 100 mg
MM 0059.02 Imp. A (EP): 2-Benzylpyridine N (C) 100 mg
MM 0059.03 Imp. B (EP): 4-Benzylpyridine N (C) 100 mg
MM 0059.09 Imp. C (EP) as Sesquifumarate: (3RS)- N,N-Dimethyl-3-phenyl-3-(pyridin-4-yl) propan-1-amine Sesquifumarate
NN
x OH
O
HO
O
1,5
(A) 100 mg
MM 0059.08 Imp. D (EP) as Dihydrochloride: N,N,N',N'-Tetramethyl-3-phenyl-3-(pyridin-2-yl)pentane-1,5-diamine Dihydrochloride N N
Nx 2 HCl
(D) 100 mg
MM 0059.01 Pheniramine N
N (A) 100 mg
MM 0059.05 Pheniramine N-Oxide Dihydrochloride N
NO
x 2 HCl
(A) 100 mg
MM 0059.06 Norpheniramine Maleate HN
N
OH
O
OH
O
x
(A) 100 mg
Phentolamine Mesilate MM 0171.04 Imp. B (Pharmeuropa) as Hydrochloride: 2-(Chloro-
methyl)-4,5-dihydro-1H-imidazole Hydrochloride Cl
NH
N
x HCl100 mg
Phenobarbital MM 0265.07 Imp. B (Pharmeuropa): 6-Amino-5-ethyl-
5-phenylpyrimidine-2,4(3H,5H)-dione NH
HN O
NH
O (A) 50 mg
MM 0265.08 Imp. C (Pharmeuropa): 5-Methyl-5-phenylpyrimidine-2,4,6(1H,3H,5H)-trione
NH
HN O
O
O (A) 50 mg
MM 0265.01 Phenylethylacetylurea (2-Phenylbutyrylurea) N
H
O
NH2
O (A) 100 mg
Pharmaceutical impurities
166 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0265.02 N-Benzoyl-N'-(2-phenyl)butanoylurea NH
O
NH
O O (A) 100 mg
MM 0265.03 Barbituric Acid
NH
HN O
O
O (C) 100 mg
Phenoxyethanol MM 0952.00 Phenoxyethanol O
OH (A) 500 mg
Phenoxymethylpenicillin Potassium MM 0026.00 Phenoxymethylpenicillin Potassium
N
SH
O
OOK
HN
OO
(A) 250 mg
MM 0160.00 Imp. A (EP) as Potassium Salt: Benzylpenicillin Potassium
N
SH
O
OOK
HN
O
(A) 250 mg
MM 0026.03 Imp. B (EP): Phenoxyacetic Acid O
OH
O
(B) 100 mg
MM 0026.04 Imp. C (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid (6-Aminopenicillanic Acid) N
SH
O
H2N
OOH (B) 100 mg
MM 0026.02 Imp. D (EP): (2S,5R,6R)-3,3-Dimethyl-7-oxo-6-[[2-(4-hydroxyphenoxy)acetyl]amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic Acid (4-Hydroxyphenoxymethylpenicillin)
N
SH
O
OOH
HN
OO
HO
(A) 100 mg
MM 0026.01 Imp. E (EP): (4S)-2-[Carboxy[(phenoxyacetyl) amino]methyl]-5,5-dimethylthiazolidine-4- carboxylic Acid (Penicilloic Acids of Phenoxymethylpenicillin)
HN
S
OOH
HN
O
O OHO
(A) 100 mg
MM 0026.05 Imp. F (EP): (2RS,4S)-5,5-Dimethyl-2- [[(phenoxyacetyl)amino]methyl]thiazolidine- 4-carboxylic Acid (Penilloic Acids of Phenoxymethylpenicillin)
HN
S
OOH
NH
OO
(A) 100 mg
Phenylbutazone MM 0548.00 Phenylbutazone
NN
O
O (A) 500 mg
MM 0548.01 Imp. A (EP): (2RS)-2-[(1,2-Diphenyldiazanyl)- carbonyl]hexanoic Acid
NNH
O
OHO
(D) 100 mg
MM 0548.02 Imp. B (EP): 4-Butyl-4-hydroxy-1,2-diphenylpyrazolidine-3,5-dione NN
O
O
OH
(A) 50 mg
MM 0548.03 Imp. C (EP): 1,2-Diphenyldiazane (1,2-Diphenylhydrazine)
HN
NH
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 167
Code Product Code Unit
MM 0548.04 Imp. D (EP): 1,2-Diphenyldiazene N
N
(C) 100 mg
MM 0548.05 Imp. E (EP) as Dihydrochloride: Biphenyl-4,4'-diamine Dihydrochloride (Benzidine Dihydrochloride)
H2N NH2 x 2 HCl (A) 100 mg
Phenylephrine Hydrochloride MM 0081.00 Phenylephrine Hydrochloride
HOHN
OH
x HCl(A) 500 mg
MM 0081.03 Imp. C (EP) as Hydrochloride: 1-(3-Hydroxy-phenyl)-2-(methylamino)ethanone Hydrochloride (Phenylephrone Hydrochloride)
HOHN
O
x HCl
(D) 100 mg
MM 0081.08 Imp. E (EP) as Hydrochloride: 2-(Benzyl-methylamino)-1-(3-hydroxyphenyl)ethanone Hydrochloride (Benzylphenylephrone Hydrochloride)
HO NO
x HCl
(D) 100 mg
MM 0081.05 1,2,3,4-Tetrahydro-4,6-dihydroxy-2-methylisoquinoline Hydrochloride HO
OH
Nx HCl
(A) 100 mg
MM 0081.06 1,2,3,4-Tetrahydro-4,8-dihydroxy-2-methylisoquinoline Hydrochloride
OH
N
OH
x HCl
(A) 50 mg
Phenylpropanolamine Hydrochloride MM 0656.00 Phenylpropanolamine Hydrochloride
[Drug Precursor] NH2
OH
and enatiomere
x HCl(A) 500 mg
Phenyltoloxamine Citrate MM 0770.00 Phenyltoloxamine Citrate
xON
OHO
OHO
OHO
OH
(A) 500 mg
Phenytoin MM 0630.00 Phenytoin
NH
HN O
O
(A) 500 mg
MM 0630.01 Imp. A (EP): Diphenylmethanone (Benzophenone)
O
(B) 100 mg
MM 0630.02 Imp. B (EP): Diphenylethanedione (Benzil)
O
O (B) 100 mg
MM 0630.04 Imp. C (EP): Amino(diphenyl)acetic Acid (2,2-Diphenylglycine)
O
OHNH2
(A) 100 mg
MM 0630.08 Imp. F (EP): 5-(4-Methylphenyl)-5-phenylimidazolidine-2,4-dione
NH
HN O
O
(A) 100 mg
MM 0630.07 1-Methyl-5,5-diphenylimidazolidine-2,4-dione
NH
N O
O
(D) 100 mg
MM 0630.03 5-(4-Methylphenyl)hydantoin NH
HN O
O
(A) 100 mg
Pharmaceutical impurities
168 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0630.06 Imp. E (EP): (Carbamoylamino)(diphenyl)acetic Acid HN
O
NH2
OOH
(A) 50 mg
Phenytoin Sodium MM 0622.00 Phenytoin Sodium
N
HN ONa
O
(A) 500 mg
MM 0630.01 Imp. A (EP): Diphenylmethanone (Benzophenone)
O
(B) 100 mg
MM 0630.02 Imp. B (EP): Diphenylethanedione (Benzil) O
O
(B) 100 mg
MM 0630.04 Imp. C (EP): Amino(diphenyl)acetic Acid (2,2-Diphenylglycine)
O
OHNH2
(A) 100 mg
MM 0630.08 Imp. F (EP): 5-(4-Methylphenyl)-5- phenylimidazolidine-2,4-dione
NH
HN O
O
(A) 100 mg
MM 0630.07 1-Methyl-5,5-diphenylimidazolidine- 2,4-dione
NH
N O
O
(D) 100 mg
MM 0630.03 5-(4-Methylphenyl)hydantoin NH
HN O
O
(A) 100 mg
Pholcodine MM 0037.00 Imp. A (EP) as Hydrochloride Trihydrate:
Morphine Hydrochloride Trihydrate [Controlled Substance]
O OHHO
N
x HClx 3 H2O
(A) 250 mg
MM 0280.00 Imp. A (EP) as Hemisulphate Pentahemihydrate: Morphine Hemisulphate Pentahemihydrate [Controlled Substance]
O OHHO
N
2
x H2SO4x 5 H2O
(A) 250 mg
MM 0422.00 Imp. B (EP) as Phosphate Hemihydrate: Codeine Phosphate Hemihydrate [Controlled Substance]
O OHO
N
x H3PO4x 1/2 H2O
(A) 100 mg
MM 0004.00 Imp. B (EP) as Monohydrate: Codeine Monohydrate [Controlled Substance]
O OHO
N
x H2O
(A) 100 mg
Pilocarpine Hydrochloride MM 0338.00 Pilocarpine Hydrochloride
x HCl
O ON
N
(A) 500 mg
MM 0338.01 Imp. A (EP) as Hydrochloride: (3R,4R)-3-Ethyl-4- [(1-methyl-1H-imidazol-5-yl)methyl]dihydrofuran- 2(3H)-one Hydrochloride (Isopilocarpine Hydrochloride)
x HCl
O ON
N
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 169
Code Product Code Unit
MM 0338.02 Imp. B (EP) as Sodium Salt: (2S,3R)-2-Ethyl-3- (hydroxymethyl)-4-(1-methyl-1H-imidazol-5- yl)butanoic Acid Sodium Salt (Pilocarpic Acid Sodium Salt)
N
N ONa
OOH (A) 100 mg
MM 0338.03 Imp. C (EP) as Sodium Salt: (2R,3R)-2-Ethyl-3- (hydroxymethyl)-4-(1-methyl-1H-imidazol-5- yl)butanoic Acid Sodium Salt (Isopilocarpic Acid Sodium Salt)
N
N ONa
OOH (A) 100 mg
Pindolol MM 0082.00 Pindolol
NH
O NHOH
(A) 250 mg
MM 0082.08 Imp. B (EP): 1-[4-[2-Hydroxy-3-[(1-methyl- ethyl)amino]propoxy]-1H-indol-1-yl]-3-[(1- methylethyl)amino]propan-2-ol
OHN
OHN
OHHN
(D) 100 mg
MM 0082.06 Imp. C (EP): 1,1'-[(1-Methylethyl)imino]bis[3- (1H-indol-4-yloxy)propan-2-ol] O N
OHHN
OH
O NH(A) 100 mg
MM 0082.02 Imp. D (EP): (2RS)-3-(1H-Indol-4-yloxy)propane- 1,2-diol O OH
OHHN
(A) 100 mg
MM 0082.01 Imp. E (EP): 1H-Indol-4-ol
NH
OH (A) 100 mg
Pipazetate Hydrochloride MM 0486.06 Bis-(2-piperidinoethyl)ether Dihydrochloride (BPEE
Dihydrochloride) ONN
x 2 HCl (A) 100 mg
MM 0486.02 1,2-Dipiperidinoethane (DPE) N
N(A) 100 mg
MM 0486.05 2-(2-Piperidinoethoxy)ethanol Hydrochloride HO
ON
x HCl (A) 100 mg
Pipemidic Acid Trihydrate MM 0401.00 Pipemidic Acid Trihydrate
N
N N
O
OH
O
N
HN
x 3 H2O
(A) 250 mg
Pipenzolate Bromide MM 0783.00 Pipenzolate Bromide
O
OOH
N+
Br-
(A) 500 mg
MM 0630.01 Diphenylmethanone (Benzophenone) O
(B) 100 mg
MM 0783.09 Benzilic Acid O
HOOH
(B) 100 mg
Piperacillin MM 0295.00 Piperacillin
N
S
OHO
H
O
HN
NH
O
ON
N
O
O
(A) 100 mg
Pharmaceutical impurities
170 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Piperacillin Sodium MM 0296.00 Piperacillin Sodium
N
S
ONaO
H
O
HN
NH
O
ON
N
OO
(A) 100 mg
MM 0253.00 Imp. A (EP) as Sodium Salt: Ampicillin Sodium
N
S
ONaO
H
O
HN
NH2
O
(A) 500 mg
MM 0296.05 Imp. E (EP): 1-Ethylpiperazine-2,3-dione NH
OO
N (A) 100 mg
MM 0296.07 Imp. G (EP): (2R)-2-[[(4-Ethyl-2,3-dioxopiperazin-1-yl)- carbonyl]amino]-2-phenylacetic Acid
OHNH
O
ONN
OO
(A) 100 mg
MM 0026.04 Imp. H (EP): (2S,5R,6R)-6-Amino-3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]-heptane-2-carboxylic Acid (6-Aminopenicillanic Acid)
N
SH
O
H2N
OOH (B) 100 mg
Piprinhydrinate MM 0155.00 Piprinhydrinate
O
NN
N N
HN
Cl
O
O
on request
MM 0155.01 Diphenylpyraline O
N
(A) 100 mg
MM 0155.02 8-Chlorotheophylline N
N N
HN
Cl
O
O
(B) 100 mg
MM 0490.02 Diphenylmethanol (Benzhydrol) OH
(B) 100 mg
Piracetam MM 0083.00 Piracetam
NH2
ON
O
(A) 500 mg
MM 0083.05 Imp. A (EP): Pyrrolidin-2-one (2-Pyrrolidone) NH
O
(B) 100 mg
MM 0083.04 Imp. B (EP): Methyl (2-Oxopyrrolidin-1-yl)acetate O
ON
O
(A) 100 mg
MM 0083.02 Imp. C (EP): Ethyl (2-Oxopyrrolidin-1-yl)acetate O
ON
O
(A) 100 mg
MM 0083.01 Imp. D (EP): (2-Oxopyrrolidin-1-yl)acetic Acid OH
ON
O
(A) 100 mg
MM 0083.03 N-Vinyl-2-pyrrolidone N
O
(A) 100 mg
MM 0083.06 2-Chloroacetamide O
NH2Cl
(C) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 171
Code Product Code Unit
Piroxicam MM 0084.00 Piroxicam
NS
O O
OH O
HN N
(A) 500 mg
MM 0084.01 Imp. A (EP): Pyridin-2-amine (2-Pyridylamine) NH2N (B) 100 mg
MM 0084.08 Imp. B (EP): 4-Hydroxy-N-(pyridin-2-yl)-2H-1,2-benzothiazine-3-carboxamide 1,1-Dioxide NH
SO O
OH O
HN N
(A) 100 mg
MM 0084.09 Imp. C (EP): 4-Hydroxy-2-methyl-2H-1,2-benzothiazine- 3-carboxamide1,1-Dioxide N
SO O
OH O
NH2
(A) 100 mg
MM 0084.07 Imp. D (EP): Methyl (1,1-Dioxido-3-oxo-1,2-benzisothiazol-2(3H)-yl)acetate N
SOO
OO
O
(A) 100 mg
MM 0084.05 Imp. E (EP): Ethyl (1,1-Dioxido-3-oxo-1,2-benzisothiazol-2(3H)-yl)acetate N
SOO
OO
O
(A) 100 mg
MM 0084.10 Imp. F (EP): 1-Methylethyl (1,1-Dioxido-3-oxo-1,2-benzisothiazol-2(3H)-yl)acetate N
SO O
OO
O
(A) 100 mg
MM 0084.04 Imp. G (EP): Methyl 4-Hydroxy- 2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide NH
SO O
OH O
O
(A) 100 mg
MM 0084.06 Imp. H (EP): Ethyl 4-Hydroxy- 2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide NH
SO O
OH O
O
(A) 100 mg
MM 0084.11 Imp. I (EP): 1-Methylethyl 4-Hydroxy-2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide NH
SO O
OH O
O
(A) 100 mg
MM 0084.02 Imp. J (EP): Methyl 4-Hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide N
SO O
OH O
O
(A) 100 mg
MM 0084.03 Imp. K (EP): Ethyl 4-Hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide N
SO O
OH O
O
(A) 100 mg
MM 0084.12 Imp. L (EP): 1-Methylethyl 4-Hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-Dioxide N
SO O
OH O
O
(A) 100 mg
MM 0084.13 N-Methylsaccharin N
SOO
O
(A) 100 mg
MM 0084.15 4-Isopropoxy-2-methyl-N-(2-pyridinyl)-2H- 1,2-benzothiazine-3-carboxamide 1,1-Dioxide N
SO O
O O
HN N
(A) 100 mg
MM 0084.16 N,N'-Di-(2-pyridinyl)oxamide HNN
ONH
O
N
(C) 50 mg
MM 0084.17 N-(2-Pyridinyl)oxamic Acid Hydrochloride HNN
OOH
O
x HCl(A) 100 mg
MM 0084.20 2-(1,1-Dioxido-3-oxo-1,2-benzisothiazol-2(3H)-yl)acetamide N
SOO
ONH2
O
(A) 100 mg
Pharmaceutical impurities
172 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0084.21 N-(6-Methyl-2-pyridyl)-4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxamide-1,1-Dioxide N
SO O
OH O
HN N
(B) 10 mg
MM 0084.22 4-Methoxy-2-methyl-N-(2-pyridyl)-2H-1,2-benzothiazine-3-carboxamide-1,1-Dioxide N
SO O
O O
HN N
(C) 10 mg
MM 0084.23 2-Methyl-N-2-(1-methylpyridinium)-2H-1,2-benzothiazine-3-carboxamide-4-olate 1,1-Dioxide N
SO O
O O
HN N
(B) 10 mg
MM 0084.24 4-Hydroxy-2H-1,2-benzothiazine-3-carboxamide 1,1-Dioxide NH
SO O
OH O
NH2
(B) 10 mg
Potassium Sorbate MM 0955.00 Potassium Sorbate O
OK
(A) 500 mg
Povidone MM 0083.03 Imp. A (EP): 1-Ethenylpyrrolidin-2-one
(1-Vinylpyrrolidin-2-one, N-Vinyl-2-pyrrolidone) N O
(A) 100 mg
MM 0083.05 Imp. B (EP): Pyrrolidin-2-one (2-Pyrrolidone) HN O
(B) 100 mg
MM 0537.01 Vinyl Acetate O
O
(B) 100 mg
Pralidoxime Methyl Sulphate MM 0689.00 Pralidoxime Methyl Sulphate
NN
OH
OS
O
OO(A) 100 mg
MM 0689.01 2-Carboxy-N-methylpyridinium Iodide N
OH
O
I-(A) 100 mg
MM 0689.02 2-Carbamoyl-N-methylpyridinium Methanesulfonate N
NH2O
SOO
O (A) 100 mg
Prasterone MM 0651.00 Prasterone O
HO
(A) 500 mg
MM 0651.02 16-Dehydropregnenolone Acetate Oxime
O
NOH
O
(A) 100 mg
Pravastatin Sodium MM 0503.00 Pravastatin Sodium
OH
O OH
O
ONa
OH
OH
(A) 100 mg
MM 0503.04 Imp. D (EP): (1S,3S,7S,8S,8aR)-3-Hydroxy-8-[2-[(2R,4R)-4-hydroxy-6-oxotetrahydro-2H-pyran-2-yl]ethyl]-7-methyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl (2S)-2-Methylbutanoate (Pravastatin Lactone)
OH
O OH
OH
O
O (D) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 173
Code Product Code Unit
PrazepamMM 0023.02 Imp. A (EP): 7-Chloro-5-phenyl-1,3-dihydro-
2H-1,4-benzodiazepin-2-one (Nordazepam) [Controlled Substance] N
HN
O
Cl
(A) 100 mg
MM 0028.03 Imp. C (EP): (2-Amino-5-chlorophenyl)phenyl- methanone
Cl
NH2
O
(B) 100 mg
Praziquantel MM 0615.00 Praziquantel O
NN
O
H
(A) 250 mg
MM 0615.02 Imp. B (EP): 2-(Cyclohexylcarbonyl)- 2,3,6,7-tetrahydro-4H-pyrazino[2,1-a]- isoquinolin-4-one
O
NN
Oon request
Prazosin Hydrochloride MM 0085.00 Prazosin Hydrochloride
NN
N
N
O
ONH2
O
O
x HCl
(A) 100 mg
MM 0085.04 Imp. A (EP): 2-Chloro-6,7-dimethoxyquinazoline-4-amine N
N
O
ONH2
Cl (A) 100 mg
MM 0085.05 Imp. B (EP): 1,4-Bis(furan-2-ylcarbonyl)piperazine
NN
O
O
O
O
(A) 100 mg
MM 0085.01 Imp. C (EP): 6,7-Dimethoxy-2-(piperazin-1-yl)quinazolin-4-amine N
NHN
N
O
ONH2
(A) 100 mg
MM 0085.02 Imp. D (EP): 1-(Furan-2-ylcarbonyl)piperazine
HN
N
O
O
(A) 100 mg
MM 0085.03 Imp. E (EP): 2,2'-(Piperazin-1,4-diyl)bis-(6,7-dimethoxyquinazolin-4-amine)
NN
N
O
O
NH2
N
N
O
O
NH2
N
(D) 100 mg
MM 0085.06 2,4-Dichloro-6,7-dimethoxyquinazoline N
N
O
O
Cl
Cl (A) 100 mg
MM 0085.07 6,7-Dimethoxyquinazoline-2,4(1H,3H)-dione
NH
HNO
O
O
O
(C) 100 mg
Prednisolone MM 0193.00 Prednisolone
O
HO OH
OOH
(A) 500 mg
Pharmaceutical impurities
174 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0185.00 Imp. A (EP): Hydrocortisone
O
HO OH
OOH
(A) 500 mg
MM 0482.00 Imp. B (Pharmeuropa): 17,21-Dihydroxypregna-1,4-diene-3,11,20-trione (Prednisone)
O
O OH
OOH
(A) 250 mg
MM 0194.00 Imp. C (Pharmeuropa): 11�,17-Dihydroxy-3,20-dioxopregna-1,4-dien-21-yl Acetate (Prednisolone Acetate)
O
HO OH
OO
O (A) 500 mg
MM 0193.01 (20R)-Hydroxyprednisolone
O
HO OH
HOOH
(C) 10 mg
MM 0193.02 (20S)-Hydroxyprednisolone
O
HO OH
HOOH
(D) 50 mg
Prednisolone Acetate MM 0194.00 Prednisolone Acetate
O
HO
OO
OH
O (A) 500 mg
MM 0187.00 Imp. A (EP): Hydrocortisone Acetate
O
HO
OO
OH
O (A) 500 mg
MM 0193.00 Imp. B (EP): Prednisolone
O
HO OH
OOH
(A) 500 mg
MM 0194.04 Prednisolone 17-Acetate
O
HO O
O
OH
O
(C) 50 mg
MM 0194.07 Prednienic Acid
O
HO OH
OHO (A) 100 mg
Prednisolone Pivalate MM 0304.00 Prednisolone Pivalate
O
HO OH
OO
O (D) 250 mg
Prednisolone Sodium Phosphate MM 0305.00 Prednisolone Sodium Phosphate
O
HO OH
OO
PONa
O ONa (A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 175
Code Product Code Unit
Prednisolone Sodium Sulfobenzoate MM 0484.01 Sodium 3-Sulfobenzoate
HO
OS
ONa
O O (C) 100 mg
Prednisone MM 0482.00 Prednisone
O
OOH
OHO(A) 250 mg
Prednisone Acetate MM 0196.00 Prednisone Acetate
O
OO
OH
O
O
(A) 250 mg
Prilocaine Hydrochloride MM 0563.00 Prilocaine Hydrochloride H
N
ONH
x HCl(A) 500 mg
MM 0563.01 Imp. A (EP): (RS)-2-Chloro-N-(2-methylphenyl)- Propanamide
HN
O
Cl(A) 100 mg
MM 0563.02 Imp. B (EP): 2-Methylbenzenamine (o-Toluidine)
NH2 (A) 100 mg
MM 0563.03 Imp. C (EP) as Hydrochloride: (RS)-2-Ethylamino- N-(2-methylphenyl)propanamide Hydrochloride
HN
O
NH
x HCl(A) 50 mg
MM 0563.04 Imp. D (EP) as Hydrochloride: (RS)-N-(3-Methyl- phenyl)-2-(propylamino)propanamide Hydrochloride
HN
O
NH x HCl
(A) 50 mg
MM 0563.05 Imp. E (EP) as Hydrochloride: (RS)-N-(4-Methylphenyl)-2-(propylamino) propanamide Hydrochloride
HN
O
NH
x HCl(A) 50 mg
Primidone MM 1030.01 Imp. A (EP) as Hydrate: 2-Ethyl-2-phenylpropane-
diamide Hydrate (Ethylphenylmalonamide Hydrate) NH2
NH2O
O
x H2O
(A) 100 mg
MM 1030.03 Imp. C (EP): (2RS)-2-Phenylbutanamide NH2
O
(A) 100 mg
MM 1030.05 Imp. E (EP): (2RS)-2-Phenylbutanoic Acid OH
O
(A) 100 mg
Probenecid MM 0657.00 Probenecid
OH
O
SN
OO
(A) 500 mg
Procainamide Hydrochloride MM 0550.00 Procainamide Hydrochloride
H2N
NH
ON x HCl
(A) 500 mg
MM 0550.02 Procainamide N-Oxide Dihydrochloride
H2N
NH
ON
x 2 HClO
(A) 100 mg
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2888/SR/0211
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 177
Code Product Code Unit
Procaine Hydrochloride MM 0596.00 Procaine Hydrochloride
ON
O
H2N
x HCl
(A) 500 mg
MM 0094.03 4-Aminobenzoic Acid OH
O
H2N
(B) 100 mg
Progesterone MM 0222.00 Progesterone
O
O (A) 500 mg
MM 0222.03 Imp. C (EP): (20R)-20-Hydroxypregn-4-en-3-one
O
HO (A) 100 mg
MM 0222.01 Imp. E (EP): (20R)-3-Oxopregn-4-en-20-yl Acetate
O
OO (D) 100 mg
MM 0222.08 11�-Hydroxyprogesterone
O
O
HO
(A) 100 mg
MM 0222.12 11-Ketoprogesterone
O
O
O
(A) 100 mg
MM 0222.14 Pregnanediol (5�-Pregnane-3�,20(S)-diol)
HO
HO
H
(A) 100 mg
MM 0222.15 Pregnanetriol (5�-Pregnane-3�,17,20(S)-triol)
HO
HO
H
OH
on request
Proguanil Hydrochloride MM 0162.05 Imp. B (EP): 4-Chloroaniline Cl
NH2
(B) 100 mg
Prolintane Hydrochloride MM 0663.00 Prolintane Hydrochloride
N x HCl(A) 100 mg
Promazine Hydrochloride MM 0290.00 Promazine Hydrochloride
S
N
N
x HCl
(A) 500 mg
MM 0290.01 Imp. A (EP): 3-(10H-Phenothiazin-10-yl)-N,N-dimethylpropan-1-amine S-Oxide (Promazine Sulphoxide)
S
N
N
O
(A) 100 mg
Pharmaceutical impurities
178 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0290.02 N,N-Dimethyl-3-chloropropylamine Hydrochloride NCl x HCl (B) 100 mg
MM 0157.02 Phenothiazine
S
HN (B) 100 mg
Promethazine Hydrochloride MM 0412.00 Promethazine Hydrochloride
SN
Nx HCl
(A) 500 mg
MM 0157.02 Imp. A (EP): Phenothiazine
S
NH
(B) 100 mg
MM 0412.02 Imp. B (EP) as Hydrochloride: (2RS)-N,N- Dimethyl-2-(10H-phenothiazin-10-yl)propan- 1-amine Hydrochloride (Isopromethazine Hydrochloride)
S
NN
x HCl
(A) 100 mg
New MM 0412.03 Imp. C (EP) as Hydrochloride: (2RS)-N-Methyl- 1-(10H-phenothiazin-10-yl)propan-2-amine Hydrochloride (Norpromethazine Hydrochloride) S
NHN
x HCl
(A) 50 mg
MM 0412.04 Imp. D (EP): (2RS)-N,N-Dimethyl-1-(10H-phenothiazin-10-yl)propan-2-amine S-Oxide (Promethazine Sulphoxide)
SN
O
N(A) 100 mg
MM 0412.05 Promethazine Sulphoxide N-Oxide Hydrochloride
S
NN
x HCl
O
O(A) 100 mg
MM 0412.06 (2RS)-N-Methyl-2-(10H-phenothiazin-10-yl)propan-1-amine Hydrochloride (Norisopromethazine Hydrochloride)
S
NHN
x HCl
(A) 100 mg
Propafenone Hydrochloride MM 0405.00 Propafenone Hydrochloride OO
OHNH
x HCl
(A) 500 mg
MM 0405.02 Imp. A (EP): 1-(2-Hydroxyphenyl)-3-phenylpropan-1-one OHO (A) 100 mg
MM 0405.03 Imp. B (EP) as Hydrochloride: (2E)-1-[2-[(2RS)-2-Hydroxy-3-(propylamino)propoxy]phenyl]-3-phenylprop-2-en-1-one Hydrochloride
OOH
NH
O
x HCl
(A) 50 mg
MM 0405.04 Imp. C (EP): 1-[2-[[(2RS)-Oxiranyl]methoxy]-phenyl]-3-phenylpropan-1-one
OO
O (A) 50 mg
New MM 0405.05 Imp. D (EP): 1-[2-[(2RS)-2,3-Dihydroxy-propoxy]phenyl]-3-phenylpropan-1-one
OOH
OHO (A) 50 mg
MM 0405.06 Imp. E (EP): 1-[2-[(2RS)-3-Chloro-2-hydroxy- propoxy]phenyl]-3-phenylpropan-1-one
OOH
ClO (A) 50 mg
MM 0405.07 Imp. F (EP): 1,1'-[2-Hydroxypropane-1,3-diylbis(oxy-2,1-phenylene)]bis(3-phenylpropan-1-one)
OOOH
O O (A) 50 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 179
Code Product Code Unit
MM 0405.09 Imp. H (EP): (2RS)-2-Phenyl-2,3-dihydro-4H-1-benzopyran-4-one
O
O
(A) 100 mg
MM 0405.01 5-Hydroxypropafenone Hydrochloride
OH
OOOH
NH
x HCl
(A) 100 mg
Propentofylline MM 0875.01 3-Methyl-7-propylxanthine
HN
N N
N
O
O
(A) 100 mg
MM 0875.02 1-(3-Hydroxypropyl)-3-methyl-7-propylxanthine
N
N N
N
O
O
HO
(A) 100 mg
MM 0875.03 1,7-Bis-(5-oxohexyl)-3-methylxanthine
N
N N
N
O
O
O
O (A) 100 mg
Propofol MM 0461.00 Propofol OH (A) 250 mg
MM 0461.03 Imp. A (EP): 2,4-Bis(1-methylethyl)phenol OH (A) 100 mg
MM 0461.04 Imp. C (EP): 2-(1-Methylethyl)phenol OH (C) 100 mg
MM 0461.02 Imp. E (EP): 3,3',5,5'-Tetrakis (1-Methylethyl)bisphenyl-4,4'-diol
OHHO
(A) 100 mg
MM 0461.05 Imp. F (EP): 3-(1-Methylethyl)phenol HO
(C) 100 mg
MM 0461.08 Imp. G (EP): 2-(1-Methylethoxy)-1,3-bis(1-methylethyl)benzene O
(A) 100 mg
MM 0461.06 Imp. H (EP): 4-(1-Methylethyl)phenol HO (C) 100 mg
MM 0461.07 Imp. I (EP): Oxydibenzene O (B) 100 mg
MM 0461.13 Imp. J (EP): 2,6-Bis(1-methylethyl)benzene-1,4-dione O
O
(A) 50 mg
MM 0461.11 Imp. K (EP): 1-(1-Methylethoxy)-2-(1-methylethyl)benzene O
(A) 100 mg
Pharmaceutical impurities
180 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0461.15 Imp. M (Pharmeuropa): 2,6-Diisopropylbenzoic Acid O OH (A) 50 mg
Propranolol Hydrochloride MM 0043.00 Propranolol Hydrochloride
OOH H
N x HCl
(A) 500 mg
MM 0043.01 Imp. A (EP): (2RS)-3-(Naphthalen-1- yloxy)propane-1,2-diol (Diol Derivative) O
OHOH
(A) 100 mg
MM 0043.03 Imp. B (EP) as Hydrochloride: 1,1'-[(1- Methylethyl)imino]bis[3-(naphthalen-1- yloxy)propan-2-ol] Hydrochloride (Tertiary Amine Derivative Hydrochloride)
OOH
OOH
N
x HCl
(A) 100 mg
MM 0043.04 1-Naphthol
OH
(B) 100 mg
MM 0043.05 1-(1-Naphtyloxy)-2,3-epoxypropane OO
(A) 100 mg
Propyl Gallate MM 1037.00 Propyl Gallate
HO
HOOH
O
O (A) 500 mg
Propyl Parahydroxybenzoate MM 0432.00 Propyl Parahydroxybenzoate
HO
O
O (A) 500 mg
MM 0045.01 Imp. A (EP): 4-Hydroxybenzoic Acid
HO
OH
O (B) 100 mg
MM 0431.00 Imp. B (EP): Methyl 4-Hydroxybenzoate (Methyl Parahydroxybenzoate)
HO
O
O (A) 500 mg
MM 0498.00 Imp. C (EP): Ethyl 4-Hydroxybenzoate (Ethyl Parahydroxybenzoate)
HO
O
O (A) 500 mg
MM 0496.00 Imp. D (EP): Butyl 4-Hydroxybenzoate (Butyl Parahydroxybenzoate)
HO
O
O (A) 500 mg
MM 0432.01 Sodium Propyl Parahydroxybenzoate
NaO
O
O (B) 100 mg
Propylhexidrine Hydrochloride MM 0664.00 Propylhexidrine Hydrochloride
NHx HCl (A) 100 mg
Propyphenazone MM 0036.00 Propyphenazone
N
N
O (A) 500 mg
MM 0036.05 Imp. A (EP): Phenazone N
N
O (A) 100 mg
MM 0036.04 Imp. C (EP): 4-[(1RS)-1,3-Dimethylbutyl]- 1,5-dimethyl-2-phenyl-1,2-dihydro-3H- pyrazol-3-one
N
N
O (A) 50 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 181
Code Product Code Unit
Proxymetacaine Hydrochloride MM 0404.00 Proxymetacaine Hydrochloride
H2N
O
O
O
N x HCl
(A) 500 mg
MM 0404.01 3-Amino-4-propoxybenzoic Acid Hydrochloride H2N
O
OH
O
x HCl
(A) 100 mg
MM 0404.02 Proxymetacaine N-Oxide Dihydrochloride H2N
O
O
O
N x 2 HClO
(C) 50 mg
Proxyphylline MM 1284.00 Proxyphylline
N
N N
N
O
O
OH (A) 250 mg
Pseudoephedrine Hydrochloride MM 2115.01 Methcathinone Hydrochloride
(2-Methylamino-1-phenylpropan-1-one Hydrochloride) [Controlled Substance]
NHO
x HCl
(A) 100 mg
MM 2115.04 (1S,2S)-N-Acetylpseudoephedrine N
OH
O
(A) 100 mg
MM 2115.05 (1S,2S)-N,O-Diacetylpseudoephedrine
NO
O
O
(A) 100 mg
New MM 0652.00 Ephedrine Hydrochloride [Drug Precursor]
HN
OH
x HCl(A) 500 mg
New MM 1147.00 Ephedrine Sulphate [Drug Precursor] H
NOH
2
x H2SO4
(A) 250 mg
Pyrazinamide MM 0385.00 Pyrazinamide
N
NNH2
O on request
MM 0385.01 Imp. A (EP): Pyrazine-2-carboxylic Acid
N
NOH
O (A) 100 mg
Pyridostigmine Bromide MM 0429.02 Imp. B (EP) as Iodide: 3-Hydroxy-1-methyl-
pyridinium Iodide I-N+
HO
(A) 100 mg
Pyridoxine Hydrochloride MM 0021.00 Pyridoxine Hydrochloride N
HO
OH
OH x HCl
(A) 500 mg
MM 0021.01 Imp. A (EP) as Hydrochloride: 6-Methyl- 1,3-dihydrofuro[3,4-c]pyridin-7-ol Hydrochloride
N
HOO
x HCl
(D) 100 mg
MM 0021.02 Imp. B (EP) as Hydrochloride: 5-(Hydroxymethyl)-2,4-dimethylpyridin-3-ol Hydrochloride
N
HOOH x HCl
(A) 100 mg
MM 0021.03 Pyridoxine Diacetate N
HO
O
O
O
O
(A) 100 mg
Pharmaceutical impurities
182 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0021.05 Pyridoxal Hydrochloride N
HO
O
OH x HCl
(A) 100 mg
MM 0021.06 Pyridoxamine Dihydrochloride N
HO
NH2
OH x 2 HCl
(A) 100 mg
MM 0021.07 4-Pyridoxic Acid N
HO
OH
OH
O
(D) 50 mg
Quetiapine Fumarate MM 1130.09 Imp. G (Pharmeuropa): Dibenzo[b,f][1,4]thiazepin-
11(10H)-one O
HN
S
(A) 100 mg
MM 1130.01 Imp. B (Pharmeuropa) as Dihydrochloride: 11-(Piperazin-1-yl)dibenzo[b,f][1,4]thiazepine Dihydrochloride
N
NHN
S
x 2 HCl
(A) 100 mg
Quinapril Hydrochloride MM 0011.01 4-Amino-6-chlorobenzene-1,3-disulphonamide (Salamide) S
Cl NH2
H2NS
NH2
O O O O (B) 100 mg
MM 0010.05 Imp. B (Pharmeuropa): (2S)-2-[[(1S)-1- (Ethoxycarbonyl)-3-phenylpropyl]amino]- propanoic Acid
HN
O O
OH
O (A) 100 mg
Quinine Dihydrochloride MM 0458.00 Quinine Dihydrochloride
N
O
HO N
H
H
x 2 HCl
(A) 500 mg
Quinuclidinyl Benzilate MM 0783.09 Benzilic Acid
HO
OOH
(B) 100 mg
MM 0825.02 3-Quinuclidinol N
OH
(A) 100 mg
Rabeprazole Sodium MM 0618.01 Rabeprazole Sodium
N
O
SO
NaN
N
O on request
MM 0618.00 Rabeprazole
N
O
SO
HN
N
O on request
MM 0618.02 2-[[[4-(3-Methoxypropoxy)-3-methyl-2-pyridinyl]methyl]thio]-1H-benzimidazole
N
OS
HN
N
O (A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 183
Code Product Code Unit
MM 0618.03 Rabeprazole Sulphone
N
OS
HN
N
O
OO
(A) 100 mg
MM 0618.04 Rabeprazole N-Oxide
N
OS
OHN
N
O
O
(D) 100 mg
MM 0618.05 Rabeprazole Sulphone N-Oxide
N
OS
HN
N
O
OO
O
(A) 100 mg
MM 0618.07 2-Chloromethyl-3-methyl-4-(3-methoxy-propoxy)pyridine Hydrochloride
N
OCl
O
x HCl
(A) 100 mg
Raloxifene Hydrochloride MM 0738.00 Raloxifene Hydrochloride SHO
OH
OO
N
x HCl
(A) 100 mg
Ramipril MM 0448.05 Imp. D (EP): Ethyl (2S)-2-[(3S,5aS,8aS,9aS)-3-
Methyl-1,4-dioxodecahydro-2H-cyclopenta[4,5]- pyrrolo[1,2-a]pyrazin-2-yl]-4-phenylbutanoate (Ramipril Diketopiperazine) N
OO
O
O
N H
H
H(A) 100 mg
MM 0010.05 Imp. F (EP): (2S)-2-[[(1S)-1-(Ethoxycarbonyl)- 3-phenylpropyl]amino]propanoic Acid
HN
OH
O
OO
(A) 100 mg
MM 0291.04 Imp. G (EP): Methylbenzene (Toluene) (C) 100 mg
MM 0448.04 Imp. M (EP): (2R,3R)-2,3-Bis(benzoyloxy)- butanedioic Acid (Dibenzoyltartric Acid)
O
OO OH
O
OHOO
(A) 100 mg
Ranitidine Hydrochloride MM 0086.00 Ranitidine Hydrochloride O
SNHN
HN
x HCl
NO2
(A) 500 mg
MM 0086.02 Imp. A (EP): N,N'-Bis[2-[[[5-[(dimethylamino)methyl]furan-2-yl]-methyl]sulphanyl]ethyl]-2-nitroethene-1,1-diamine
OSN
HN
NO2
HN O
S N(A) 100 mg
MM 0086.01 Imp. B (EP): 2-[[[5-[(Dimethylamino)methyl]- furan-2-yl]methyl]sulphanyl]ethanamine
OSN
NH2 (A) 100 mg
MM 0086.03 Imp. C (EP): N-[2-[[[5-[(Dimethylamino)- methyl]furan-2-yl]methyl]sulphinyl]ethyl]-N'- methyl-2-nitroethene-1,1-diamine (Ranitidine Sulphoxide)
OSN
HN
HN
O
NO2
(A) 100 mg
MM 0086.06 Imp. D (EP) as Sodium Salt: N-[2-[[[5- [(Dimethylamino)methyl]furan-2-yl]- methyl]sulphanyl]ethyl]-2-nitroacetamide Sodium Salt
OSN
HN ONa
NO2
(A) 100 mg
Pharmaceutical impurities
184 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0086.05 Imp. E (EP): N-[2-[[[5-[(Dimethyloxidoamino) methyl]furan-2-yl]methyl]sulphanyl] ethyl]-N'-methyl-2-nitroethene-1,1-diamine (Ranitidine N-Oxide)
OSN
HN
HN
O
NO2
(D) 100 mg
MM 0086.17 Imp. F (EP) as Hydrochloride: [5-[(Dimethyl- amino)methyl]furan-2-yl]methanol Hydrochloride
OOHN x HCl (A) 100 mg
MM 0086.08 Imp. H (EP): N-Methyl-2-nitroacetamide
NH
O
NO2 (A) 100 mg
MM 0086.10 Imp. I (EP): 2,2'-Methylenebis[N-[2-[[[5-[(dimethyl- amino)methyl]furan-2-yl]methyl]sulphanyl]ethyl]-N'- methyl-2-nitroethene-1,1-diamine]
OSN
NH
NH
OSN
HN
HN
NO2
NO2
(A) 100 mg
MM 0220.09 Imp. K (EP): N-Methyl-1-methylthio-2- nitroethenamine ((EZ)-N-Methyl-1-(methyl- sulphanyl)-2-nitroethen-1-amine) N
HS
NO2 (A) 100 mg
MM 0086.07 Imp. G (EP): 3-(Methylamino)-5,6-dihydro-2H-1,4-thiazin-2-one Oxime N
S
NH
NOH (A) 100 mg
Ranolazine Dihydrochloride New MM 1320.01 2-[(2-Methoxyphenoxy)methyl]oxirane
O
OO (A) 100 mg
Reagents MM 0334.01 Diethylhexylphthalate (Bis-(2-ethylhexyl) Phthalate)
O
O
O
O
(C) 500 mg
MM 0334.02 3-(N-Morpholino)propane Sulfonic Acid (MOPS) O
N SOH
O O
(C) 500 mg
MM 0334.03 3-(N-Morpholino)ethane Sulfonic Acid (MES)
O
NS
OH
O O (C) 500 mg
MM 0334.08 Salicylaldehyde Azine N N
HO
OH
(A) 100 mg
Repaglinide New MM 0944.00 Repaglinide
NH
N O OH
O
O
(A) 100 mg
New MM 0944.01 Imp. C (EP) as N-Acetyl-L-glutamate: (1S)- 3-Methyl-1-[2-(piperidin-1-yl)phenyl] butan-1-amine N-Acetyl-L-glutamate
NH2
N
O
HO OH
O
HN
O
x
(A) 100 mg
New MM 0944.02 Imp. B (EP): [3-Ethoxy-4-(ethoxycarbonyl)- phenyl]acetic Acid
HO
O O
O
O
(A) 100 mg
Ribavirin MM 0542.00 Ribavirin
O
OHOH
HON
NN
H2N
O (A) 250 mg
MM 0542.01 Imp. A (EP): 1-�-D-Ribofuranosyl-1H-1,2,4- triazole-3-carboxylic Acid
O
OHOH
HON
NN
HO
O (D) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 185
Code Product Code Unit
MM 0542.03 Imp. C (EP): 1H-1,2,4-Triazole-3-carboxylic Acid
NNH
NHO
O (D) 100 mg
MM 0542.04 Imp. D (EP): 1H-1,2,4-Triazole-3-carboxamide
NNH
NH2N
O (D) 100 mg
MM 0542.05 Imp. E (EP): 1-(5-O-Benzoyl-�-D-ribofuranosyl)-1H-1,2,4-triazole-3-carboxamide (5'-O-Benzoylribavirin)
O
OHOH
ON
NN
O
H2N
O (D) 100 mg
MM 0542.06 Imp. F (EP): 1-(5-O-Acetyl-�-D-ribofuranosyl)-1H-1,2,4-triazole-3-carboxamide (5'-O-Acetylribavirin)
O
OHOH
ON
NN
O
H2N
O (D) 100 mg
Riboflavin MM 0030.00 Riboflavin
N
N
NH
N
O
O
HO OHOH
OH
(A) 500 mg
Rifampicin MM 0514.02 3-Formylrifamycin Isonicotinylhydrazone
OOH
OH
OO
HN
O
O
OHO
O
N
HN
OH
OH
O
Non request
Risedronate Sodium 2.5 Hydrate New MM 0777.00 Risedronate Sodium 2.5 Hydrate
NP
O
PO
HOOH
x 2,5 H2O
OH
OHONa
(A) 100 mg
Risperidone MM 0491.00 Risperidone
N
N
ON
N O
F(A) 100 mg
MM 0491.01 Imp. A (EP): 3-[2-[4-[(E)-(2,4-Difluorophenyl)- (hydroxyimino)methyl]piperidin-1-yl]ethyl]-2- methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]- pyrimidin-4-one
N
N
ON
N
F
FHO
(D) 100 mg
MM 0491.02 Imp. B (EP): 3-[2-[4-[(Z)-(2,4-Difluorophenyl)- (hydroxyimino)methyl]piperidin-1-yl]ethyl]-2- methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]- pyrimidin-4-one
N
N
ON
N
F
FOH
(A) 100 mg
MM 0491.04 Imp. D (EP): 3-[2-[4-(5-Fluoro-1,2-benzisoxazol- 3-yl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9- tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one
N
N
ON
N O
F (D) 100 mg
MM 0491.05 Imp. E (EP): (6RS)-3-[2-[4-(6-Fluoro-1,2- benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2,6- dimethyl-6,7,8,9-tetrahydro-4H-pyrido- [1,2-a]pyrimidin-4-one
N
N
O
N
N O
F(D) 50 mg
Pharmaceutical impurities
186 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0491.08 Imp. F (EP): 2-[2-Methyl-4-oxo-6,7,8,9-tetrahydro-4H-pyrido[1,2-a] pyrimidin-3-yl]ethyl 4-(6-Fluoro-1,2-benzisoxazol-3-yl) piperidin-1-carboxylate
O N
N O
FO
N
N
O
(A) 100 mg
MM 0491.10 Imp. H (EP): 3-[2-[4-(2,4-Difluorobenzoyl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido-[1,2-a]pyrimidin-4-one
N
N
ON
O
F
F
(A) 100 mg
MM 0491.03 Imp. C (EP): (9RS)-3-[2-[4-(6-Fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-9-hydroxy-2-methyl-6,7,8,9-tetrahydro-4H-pyrido[1,2-a]pyrimidin-4-one (9-Hydroxyrisperidone)
N
N
O
N
N O
F
OH (D) 100 mg
MM 0491.09 3-[2-[4-(4-Fluoro-2-hydroxybenzoyl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido-[1,2-a]pyrimidin-4-one
N
N
ON
O
F
OH
(A) 100 mg
MM 0491.13 Imp. L (Pharmeuropa) as Hydrochloride: 3-(2- Chloroethyl)-2-methyl-6,7,8,9-tetrahydro-4H- pyrido[1,2-a]pyrimidin-4-one Hydrochloride (Risperidone Piperidopyrimidinone Intermediate Hydrochloride)
N
N
O
Clx HCl
(A) 100 mg
New MM 0491.18 3-[2-[4-[2-Fluoro-4-[4-(6-fluoro-1,2-benzisoxazol-3-yl)piperidin-1-yl]benzoyl]piperidin-1-yl]ethyl]-2-methyl-6,7,8,9-tetrahydro-4H-pyrido-[1,2-a]-pyrimidin-4-one
N
N
ON
O
N
F
NO
F (D) 50 mg
Ritodrine Hydrochloride MM 0063.06 Imp. A (BP): Tyramine
HO
NH2 (B) 100 mg
Ronidazole MM 1026.01 (1-Methyl-5-nitroimidazol-2-yl)methanol
N
NO2N OH
(A) 100 mg
Rosiglitazone Maleate MM 0522.01 Rosiglitazone Maleate
N
NO N
H
SO
O
O
OH
OH
O
x
(D) 100 mg
Rosuvastatin Calcium New MM 0936.02 4-(4-Fluorophenyl)-6-isopropyl-
2-[methyl(methylsulfonyl)amino]pyrimidine-5-methanol N N
NS
O O
FHO
(A) 100 mg
Rutoside Trihydrate MM 0109.03 Imp. C (EP) as Dihydrate: 2-(3,4-Dihydroxyphenyl)-
3,5,7-trihydroxy-4H-1-benzopyran-4-one Dihydrate (Quercetin Dihydrate)
O
HO OH
O
OH
OH
HO x 2 H2O
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 187
Code Product Code Unit
Saccharin Sodium MM 0818.00 Saccharin Sodium
NNaS
OO
O
(A) 500 mg
Salbutamol Sulphate MM 0381.00 Salbutamol Sulphate
x H2SO4
HO
OH
OHHN
2
(A) 500 mg
MM 0381.02 Imp. B (EP): (1RS)-2-[(1,1-Dimethylethyl)- amino]-1-(4-hydroxyphenyl)ethanol
HO
OHHN
(A) 50 mg
MM 0381.03 Imp. C (EP): (1RS)-2-[(1,1-Dimethylethyl)amino]-1-(4-hydroxy-3-methylphenyl)ethanol
HO
OH HN
(A) 50 mg
MM 0381.05 Imp. E (EP): (1RS)-2-[Benzyl(1,1-dimethyl- ethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)- phenyl]ethanol
HO
OH
OH
N
(A) 100 mg
MM 0381.08 Imp. H (EP): 4-[2-[1,1-Dimethylethyl)amino]ethyl]-2-methylphenol
HO
HN (A) 100 mg
MM 0381.07 Imp. G (EP) as Hydrochloride: 2-[Benzyl(1,1-dimethylethyl)amino]-1-[4-hydroxy-3-(hydroxy-methyl)phenyl]ethanone Hydrochloride
HO
OH
ON x HCl
(D) 50 mg
MM 0381.10 Imp. J (EP) as Hydrochloride: 2-[(1,1-Dimethyl-ethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)-phenyl]ethanone Hydrochloride (Salbutamone Hydrochloride)
HO
OH
OHN
x HCl
(D) 50 mg
MM 0381.17 4-[(1RS)-2-(tert-Butylamino)-1-hydroxyethyl]-2- ethylphenol Hydrobromide
HO
OHHN
x HBr
(A) 50 mg
Salicylic Acid MM 0045.00 Salicylic Acid
OH
OH
O (A) 500 mg
MM 0045.01 Imp. A (EP): 4-Hydroxybenzoic Acid HO
O
OH
(B) 100 mg
MM 0045.02 Imp. B (EP): 4-Hydroxyisophthalic Acid HO
OH
O
OH
O (A) 100 mg
MM 0045.11 Imp. C (EP): Phenol OH
(B) 100 mg
MM 0045.12 Imidazole Salicylate
OH
O
O
NH
HN
(A) 100 mg
MM 0045.13 Choline Salicylate
OH
O
O
NOH
on request
Pharmaceutical impurities
188 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0045.14 N,N-Diethylsalicylamide
OH
N
O (A) 100 mg
Salmeterol Xinafoate New MM 0536.07 Imp. F (EP): (1RS)-1-(4-Hydroxy-3-methylphenyl)-
2-[[6-(4-phenylbutoxy)hexyl]amino]ethanol HO
OHHN
O
(A) 50 mg
New MM 0536.03 Imp. B (EP): (1RS)-1-[4-Hydroxy-3-(hydroxy- methyl)phenyl]-2-[[6-(2-phenylethoxy)hexyl]- amino]ethanol
HO
OH
OHHN
O
(A) 100 mg
Secnidazole MM 0119.00 Secnidazole
N
NO2N
OH (A) 100 mg
MM 0012.02 2-Methyl-4-nitroimidazole NH
NO2N (B) 100 mg
Selegiline Hydrochloride MM 0656.00 Imp. C (EP) as Hydrochloride: (1RS, 2SR)-2-
Amino-1-phenylpropan-1-ol Hydrochloride (Phenylpropanolamine Hydrochloride)
NH2
OH
and enatiomer
x HCl
(A) 500 mg
Sertraline Hydrochloride MM 0317.01 Sertraline Hydrochloride HN
ClCl
x HCl
(A) 100 mg
MM 0317.00 Sertraline HN
ClCl
(A) 100 mg
MM 0317.05 Imp. B (EP) as Hydrochloride: (1RS,4RS)-N- Methyl-4-phenyl-1,2,3,4-tetrahydronaphthalen- 1-amine Hydrochloride
HN
and enantiomer
x HCl
(A) 100 mg
MM 0317.06 Imp. C (EP) as Hydrochloride: (1RS,4RS)-4- 4-Chlorophenyl)-N-methyl-1,2,3,4-tetrahydro- naphthalen-1-amine Hydrochloride
HN
Cland enantiomer
x HCl
(D) 100 mg
MM 0792.03 Imp. E (EP) as Racemate: Hydroxyphenylacetic Acid (Mandelic Acid)
OHOH
O (A) 100 mg
MM 0317.09 Imp. F (EP) as Racemate: 4-(3,4-Dichlorophenyl)- 3,4-dihydronaphthalen-1(2H)-one (Sertraline Tetralone Derivative)
Cl
Cl
O (A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 189
Code Product Code Unit
MM 0317.10 Imp. E (EP): (2R)-Hydroxyphenylacetic Acid ((R)-Mandelic Acid)
OH
OH
O (A) 100 mg
Sibutramine Hydrochloride MM 0991.02 Imp. D (Pharmeuropa) as Hydrochloride: (1RS)-
1-[1-(4-Chlorophenyl)cyclobutyl]- N,3-dimethylbutan-1-amine Hydrochloride (N-Monodesmethylsibutramine Hydrochloride)
ClHN
x HCl
(A) 100 mg
MM 0991.03 Imp. G (Pharmeuropa) as Hydrochloride: (1RS)-1-[1-(4-Chlorophenyl)cyclobutyl]-3-methylbutan- 1-amine Hydrochloride (N,N-Didesmethyl- sibutramine Hydrochloride)
ClNH2
x HCl
(A) 100 mg
New MM 0991.05 Imp. B (Pharmeuropa) as Hydrochloride: (1RS)-1-[1-(3-Chlorophenyl)cyclobutyl]-N,N,3-trimethyl- butan-1-amine Hydrochloride N
Cl x HCl
(A) 50 mg
New MM 0991.06 Imp. C (Pharmeuropa) as Hydrochloride: (1RS)-1-[1-(4-Chlorophenyl)cyclobutyl]-N,N-dimethyl- pentan-1-amine Hydrochloride
ClN
x HCl
(A) 50 mg
New MM 0991.07 Imp. E (Pharmeuropa): (4-Chlorophenyl)acetonitrile Cl
N(A) 50 mg
MM 0991.09 Imp. H (Pharmeuropa): 2-(4-Chlorophenyl)-2-(prop- 2-en-1-yl)pent-4-enenitrile
Cl
N
50 mg
MM 0991.10 Imp. I (Pharmeuropa): (1RS)-1-[1-(4-Chlorophenyl)- cyclobutyl]-3-methylbutan-1-ol
ClOH
(A) 50 mg
New MM 0991.11 Imp. J (Pharmeuropa): 1-[1-(4-Chlorophenyl)cyclo- butyl]-3-methylbutan-1-one
ClO
(A) 50 mg
Sildenafil Citrate MM 0254.00 Sildenafil Citrate
O
SN
OO
N
N
HNN
N
O
HOO
OH
O
HO
O
HO
x
(D) 100 mg
MM 0254.09 Sildenafil
O
SN
OO
NN
HNN
N
O (D) 100 mg
MM 0254.01 4-[[2-Ethoxy-5-[(4-methyl-1-piperazinyl)-sulfonyl]benzoyl]amino]-1-methyl-3-propyl-1H-pyrazole-5-carboxamide
O
SN
OO
NNH
H2NN
N
O
O
on request
MM 0254.02 2-Ethoxy-5-[(4-methyl-1-piperazinyl)sulfonyl]benzoic Acid
O
SN
OO
N
OH
O (A) 100 mg
MM 0254.04 Sildenafil N-Oxide
O
SN
OO
NN
HNN
N
O
O
(A) 100 mg
MM 0254.05 4-Amino-1-methyl-3-propyl-1H-pyrazole-5-carboxamide
H2N
H2NN
N
O (A) 100 mg
MM 0254.06 3-(4,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxy-benzenesulfonic Acid
O
SHO
OO
N
HNN
N
O on request
Pharmaceutical impurities
190 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0254.08 1-[[3-(4,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxyphenyl]sulfonyl]piperazine (Desmethylsildenafil)
O
SN
OO
HNN
HNN
N
O (D) 100 mg
MM 0254.11 3-(4,7-Dihydro-1-methyl-7-oxo-3-propyl-1H-pyrazolo[4,3-d]pyrimidin-5-yl)-4-ethoxy-N-[2-(methylamino)ethyl]- benzenesulfonamide
SNH
O O
NHO
N
HNN
N
O on request
MM 0254.21 2-Ethoxy-5-(4-methylpiperazine-1-sulfonyl)benzaldehyde (1-[(4-Ethoxy-3-formylphenyl)sulfonyl]-4-methylpiperazine)
O
SN
OO
N
O (A) 100 mg
MM 0254.22 Desethylsildenafil (5-[2-Hydroxy-5-(4-methylpiperazinylsulfonyl)phenyl]-1-methyl-3-n-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one
OH
SN
OO
N
N
HNN
N
O (D) 100 mg
New MM 0254.29 5-(2-Ethoxyphenyl)-1-methyl-3n-propyl-1,6-dihydro-7H-pyrazolo[4,3-d]pyrimidin-7-one
O
N
HNN
N
O (A) 100 mg
Silybin MM 0472.00 Silybin
OHO
OH OOH
O
O
OH
OOH on request
Simvastatin MM 0158.00 Simvastatin
HO O
O
O
OH
(A) 100 mg
MM 0158.01 Imp. A (EP) as Sodium Salt: (3R,5R)-7- [(1S,2S,6R,8S,8aR)-8-[(2,2-Dimethylbutanoyl) oxy]-2,6-dimethyl-1,2,6,7,8,8a-hexahydronaphthalen- 1-yl]-3,5-dihydroxyheptanoic Acid Sodium Salt (Tenivastatin Sodium Salt; Simvastatin Hydroxy Acid Sodium Salt)
HO O
OH
OH
O
ONa
(A) 100 mg
MM 0158.02 Imp. B (EP): (1S,3R,7S,8S,8aR)-8-[2-[(2R,4R)-4-(Acetyloxy)-6-oxotetrahydro-2H-pyran-2-yl]ethyl]-3,7-dimethyl-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-Dimethylbutanoate (Simvastatin Acetate Ester)
HO O
O
O
O
O(A) 100 mg
MM 0158.03 Imp. C (EP): (1S,3R,7S,8S,8aR)-3,7-Dimethyl-8-[2-[(2R)-6-oxo-3,6-dihydro-2H-pyran-2-yl]ethyl]-1,2,3,7,8,8a-hexahydronaphthalen-1-yl 2,2-Dimethylbutanoate (Anhydrosimvastatin) H
O O
O
O (A) 100 mg
MM 0050.00 Imp. E (EP): Lovastatin
HO O
O
O
OH
(A) 100 mg
Sodium Benzoate MM 0730.00 Sodium Benzoate
ONa
O (A) 500 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 191
Code Product Code Unit
Sodium Cromoglicate MM 0039.00 Sodium Cromoglicate
O OOH
O O
OO
NaO
O
ONa
O (A) 500 mg
MM 0039.01 Succinophenone; Diphenacyl O
O
(A) 100 mg
MM 0039.02 1,3-Bis(2-acetyl-3-hydroxyphenoxy)-2-propanol
O OOH
HO OH
OO
(A) 100 mg
MM 0039.03 2',6'-Dihydroxyacetophenone OH
OH
O (B) 100 mg
MM 0039.04 Ethyl Cromoglicate
O OOH
O O
OO
O
O
O
O (A) 100 mg
Sodium Cyclamate MM 0678.05 Cyclamic Acid H
NS
OH
O O
(A) 100 mg
MM 0093.17 Imp. B (EP) as Hydrochloride: Aniline Hydrochloride (Phenylamine Hydrochloride)
NH2x HCl
(B) 100 mg
MM 0678.03 Imp. C (EP): Cyclohexanamine NH2 (C) 100 mg
MM 0678.04 Imp. D (EP): N-Cyclohexylcyclohexanamine HN (C) 100 mg
Sodium Fluoride MM 0734.00 Sodium Fluoride NaF (A) 500 mg
Sodium Picosulfate MM 0054.00 Sodium Picosulfate
N
O OSS
NaO ONa
O O O O(A) 500 mg
MM 0054.01 Imp. A (EP): 4-[(RS)-(4-Hydroxyphenyl)- (pyridin-2-yl)methyl]phenyl Sodium Sulphate (4-[(Pyridin-2-yl)(4-hydroxyphenyl)methyl]- phenyl Sodium Sulphate) N
HO OS
ONa
O O(A) 100 mg
MM 0031.01 Imp. B (EP): 4,4'-[(Pyridin-2-yl)methylene]- diphenol (4,4'-(Pyridin-2-ylmethylene)di- phenol) N
HO OH (A) 100 mg
MM 0054.02 Imp. C (EP): 2-[(RS)-(Pyridin-2-yl)[4-(sulphonato- oxy)phenyl]methyl]phenyl Disodium Sulphate (2,4'-[(Pyridin-2-yl)-methylene]bisphenyl Bis- (Sodium Sulphate)) N
O
OS
SONa
NaO
O O
O O
(D) 50 mg
MM 0031.04 2,4'-[(Pyridin-2-yl)methylene]bisphenol(2-[(RS)-(4-Hydroxyphenyl)(pyridin-2-yl)methyl]phenol)
N
HO
OH
(A) 50 mg
Sodium Thiophene-2-carboxylate MM 1081.00 Sodium Thiophene-2-carboxylate
SONa
O (A) 250 mg
Pharmaceutical impurities
192 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Sorbic Acid MM 0954.00 Sorbic Acid O
OH
(A) 500 mg
Sotalol Hydrochloride MM 0046.00 Sotalol Hydrochloride
NH
HN
SO O
OH
x HCl
(A) 100 mg
MM 0046.01 Imp. A (EP) as Hydrochloride: N-[4-[2- [(1-Methylethyl)amino]ethyl]phenyl]- methanesulphonamide Hydrochloride N
H
HN
SO O x HCl
(A) 100 mg
MM 0046.02 Imp. B (EP) as Hydrochloride: N-[4-[[(1- Methylethyl)amino]acetyl]phenyl]- methanesulphonamide Hydrochloride
NH
HN
SO O
O
x HCl
(A) 100 mg
MM 0046.03 Imp. C (EP):N-(4-Formylphenyl)methanesulphonamide
NH
SO O
O (A) 100 mg
Spironolactone MM 0197.00 Spironolactone
O S
O
O
O (A) 500 mg
New MM 0197.01 Imp. F (EP): (2'R)-3',4'-Dihydro-5'H-spiro[androst- 4,6-diene-17,2'-furan]-3,5'-dione (Canrenone)
O
O
O (A) 100 mg
Stavudine MM 0534.01 Imp. A (EP): 5-Methylpyrimidine-2,4(1H,3H)-dione (Thymine)
NH
HN
O
O (A) 100 mg
MM 0534.03 Imp. C (EP): 1-(2-Deoxy-�-D-erythro-pentofuranosyl)-5-methylpyrimidine-2,4(1H,3H)-dione (Thymidine)
O
HON
HN
O
O
OH
(A) 100 mg
Strychnine Nitrate MM 0658.00 Strychnine Nitrate
N
N
O O
H
H
H
x HNO3
(A) 500 mg
MM 0658.02 Strychnine N-Oxide Hydrochloride
N
N
O O
H
H
H
x HCl
O on request
Sulfacetamide MM 0579.00 Sulfacetamide
H2N
SNH
OO O (A) 500 mg
Sulfacetamide Sodium MM 1087.00 Sulfacetamide Sodium Monohydrate
H2N
SN
OO
x H2O
O
Na
(A) 500 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 193
Code Product Code Unit
MM 0227.05 Imp. A (EP): Sulfanilamide S
NH2
O O
H2N
(A) 100 mg
Sulfadiazine MM 0623.00 Sulfadiazine
S
H2N
NH
OO
N
N (A) 500 mg
MM 0623.03 Imp. A (Pharmeuropa): Pyrimidin-2-amine H2N N
N (A) 100 mg
MM 0227.04 Imp. B (Pharmeuropa): 4-Aminobenzenesulfonic Acid (Sulphanilic Acid) S
H2N
OH
OO (A) 100 mg
MM 0227.05 Imp. D (Pharmeuropa): 4-Aminobenzenesulfonamide (Sulfanilamide) S
H2N
NH2
OO (A) 100 mg
MM 0623.02 N4-Acetylsulfadiazine S
NH
OO
N
N
NH
O
(A) 50 mg
Sulfadimidine MM 623.00 Imp. B (Pharmeuropa): 4-Amino-N-pyrimidin-2-
ylbenzenesulphonamide (Sulfadiazine)
H2N
SNH
O O
N
N (A) 500 mg
MM 0227.04 Imp. F (Pharmeuropa): 4-Aminobenzenesulphonic Acid (Sulphanilic Acid)
H2N
SOH
O O (A) 100 mg
MM 0227.05 Imp. D (Pharmeuropa): 4-Aminobenzenesulphonamide (Sulfanilamide)
H2N
SNH2
O O (A) 100 mg
MM 0579.00 Imp. E (Pharmeuropa): N-[(4-Aminophenyl)sulfonyl]- acetamide (Sulfacetamide)
H2N
SNH
O O O (A) 500 mg
MM 0581.00 Imp. A (Pharmeuropa): 4-Amino-N-(4-methyl-2- pyrimidyl)benzenesulphonamide (Sulfamerazine)
H2N
SNH
O O
N
N(A) 500 mg
MM 0883.00 Imp. C (Pharmeuropa): (4-Aminophenylsulphonyl)- guanidine (Sulfaguanidine)
H2N
SNH
O O
NH2
NH (A) 100 mg
Sulfadimethoxine Sodium MM 1020.00 Sulfadimethoxine Sodium
S
H2N
NNa
OO NN
O
O
(A) 500 mg
Sulfafurazole MM 0583.00 Sulfafurazole
H2N
SNH
OO O N (A) 500 mg
Sulfaguanidine MM 0883.00 Sulfaguanidine
H2N
SNH
O O
NH2
NH (A) 100 mg
MM 0227.05 Imp. A (EP): 4-Aminobenzenesulphonamide (Sulphanilamide)
H2N
SNH2
O O (A) 100 mg
Pharmaceutical impurities
194 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0883.02 Imp. B (EP): N-[(4-Aminophenyl)sulphonyl]- urea (Sulphacarbamide)
H2N
SNH
O O
NH2
O (A) 50 mg
Sulfamerazine MM 0581.00 Sulfamerazine
N
NNH
S
H2N
OO
(A) 500 mg
MM 0227.05 Sulphanilamide NH2
S
H2N
OO (A) 100 mg
Sulfamethoxazole MM 0227.00 Sulfamethoxazole
NH
S
H2N
O O
NO
(A) 500 mg
MM 0227.01 Imp. A (EP): N-[4-[(5-Methylisoxazol-3-yl)-sulphamoyl]phenyl]acetamide
NH
SO O
NO
NH
O
(A) 100 mg
MM 0227.03 Imp. B (EP): 4-[[(4-Aminophenyl)sulphonyl]amino]-N-(5-methylisoxazol-3-yl)benzenesulphonamide
NH
SN
O
NH
S
H2N
O O
O O
(A) 100 mg
MM 0227.02 Imp. C (EP): 5-Methylisoxazol-3-amine
H2N NO
(B) 100 mg
MM 0227.04 Imp. D (EP): 4-Aminobenzenesulphonic Acid (Sulphanilic Acid) OH
S
H2N
O O (A) 100 mg
MM 0227.05 Imp. E (EP): 4-Aminobenzenesulphonamide (Sulphanilamide) NH2
S
H2N
O O (A) 100 mg
Sulfamethylphenazole MM 1108.00 Sulfamethylphenazole
NH
S
H2N
NN
O O(A) 100 mg
Sulfaquinoxaline Sodium MM 0702.00 Sulfaquinoxaline Sodium
N
NNaN
SO O
NH2 on request
Sulfasalazine MM 0045.00 Imp. H (EP): Salicylic Acid
HO
O OH
(A) 500 mg
Sulfathiazole MM 0578.00 Sulfathiazole N
SNH
SOO
H2N
(A) 500 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 195
Code Product Code Unit
Sulindac MM 0624.00 Sulindac
OH
F
SO
O
(A) 500 mg
Sulpiride MM 0051.00 Sulpiride
NNH
O
SO O
H2N
O
(A) 500 mg
MM 0051.01 Imp. A (EP): [(2RS)-1-Ethylpyrrolidin-2-yl]methanamine N
H2N
(A) 100 mg
MM 0051.02 Imp. B (EP): Methyl 2-Methoxy-5-sulphamoylbenzoate O
OS
O
O
H2N
O
(A) 100 mg
MM 0051.03 Imp. C (EP): Ethyl 2-Methoxy-5-sulphamoylbenzoate O
O
SO
O
H2N
O
(A) 100 mg
MM 0051.04 Imp. D (EP): 2-Methoxy-5-sulphamoylbenzoic Acid OH
O
SO
O
H2N
O
(A) 100 mg
MM 0051.05 Imp. E (EP): 2-Methoxy-5-sulphamoylbenzamide NH2
O
SO
O
H2N
O
(A) 100 mg
MM 0051.06 Imp. F (EP): 1-Ethyl-2-[[(2-methoxy-5- sulphamoylbenzoyl)amino]methyl]pyrrolidine 1 -Oxide (Sulpiride N-Oxide)
NNH
O
SO
O NH2
O
O(A) 100 mg
MM 0051.07 Imp. G (EP): (RS)-N-[(1-Ethylpyrrolidin-2-yl)methyl]-2-hydroxy-5-sulphamoylbenzamide N
NH
OS
O O
H2N
OH
(A) 100 mg
MM 0051.08 5-Sulphamoylsalicylic Acid OH
O
SO
O
H2N
OH
(A) 100 mg
MM 0051.09 5-Sulphosalicylic Acid Dihydrate OH
O
SO
O
HO
OH
x 2 H2O
(C) 100 mg
Sumatriptan Succinate New MM 0310.04 Imp. D (EP) as Maleate: N,N-Dimethyl-
2-[5-[(methylsulfamoyl)methyl]-1H-indol- 3-yl]-ethanamine N-Oxide Maleate
HN
SNH
NO
O OO
OH
O
OHx
(A) 100 mg
New MM 0310.05 Imp. E (EP): [3-(2-Aminoethyl)-1H-indol-5-yl]- N-methylmethanesulfonamide
HN
SNH
NH2
O O(A) 100 mg
Suplatast Tosilate MM 0722.01 Methyl Toluene-4-sulphonate S
O
OO (B) 100 mg
Tamoxifen Citrate MM 0053.00 Tamoxifen Citrate
ON
O
HO
O
HO O
OHHOx
(A) 100 mg
Pharmaceutical impurities
196 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0053.02 Imp. B (EP): 1-[4-(2-Dimethylaminoethoxy)phenyl]-1,2-diphenylbutan-1-ol O
N
OH
(A) 100 mg
MM 0053.14 Imp. C (EP) Z-Isomer: 2-[4-[(Z)-1,2-Diphenyl-ethenyl]phenoxy]-N,N-dimethylethanamine O
N
on request
MM 0053.15 Imp. C (EP) E-Isomer: 2-[4-[(E)-1,2-Diphenylethenyl]phenoxy]-N,N-dimethylethanamine
ON (A) 50 mg
MM 0053.16 Imp. D (EP) Z-Isomer: 2-[4-[(Z)-1,2-Diphenylprop-1-enyl]phenoxy]-N,N-dimethylethanamine O
N
(A) 50 mg
MM 0053.17 Imp. D (EP) E-Isomer: 2-[4-[(E)-1,2-Diphenylprop-1-enyl]phenoxy]-N,N-dimethylethanamine
ON on request
MM 0053.05 Imp. E (EP):2-[2-[(EZ)-1,2-Diphenylbut-1-enyl)phenoxy]-N,N-dimethylethanamine
ON
(A) 100 mg
MM 0053.12 Imp. F (EP) as Hydrochloride: 2-[4-[(Z)-1,2-Diphenylbut-1-enyl]phenoxy]-N-methylethanamine Hydrochloride O
NH
x HCl
(A) 100 mg
MM 0053.07 Imp. G (EP): (2RS)-1-[4-[2-(Dimethylamino)ethoxy]phenyl]-2-phenylbutan-1-one O
N
O
(A) 100 mg
MM 0053.08 1,2-Diphenylbutan-1-one
O
(A) 100 mg
MM 0053.09 1-(4-Methoxyphenyl)-1,2-diphenylbutan-1-ol O
OH
(A) 100 mg
MM 0053.10 (EZ)-1-(4-Hydroxyphenyl)-1,2-diphenylbut-1-ene OH
(C) 50 mg
MM 0053.18 Tamoxifen N-Oxide O
NO
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 197
Code Product Code Unit
Tamsulosin Hydrochloride MM 0938.00 Tamsulosin Hydrochloride
O
O
HN
O
SNH2
OO
x HCl
(D) 100 mg
MM 0938.02 Imp. A (EP) as Hydrochloride: 5-[(2R)-2- [Bis[2-(2-ethoxyphenoxy)ethyl]amino]- propyl]-2-methoxybenzenesulfonamide Hydrochloride
O
ON
O
SNH2
OOx HCl
O
O (A) 100 mg
MM 0938.03 Imp. B (EP): 5-[(2R)-2-Aminopropyl]-2-methoxybenzenesulfonamide H2N
O
SNH2
OO (A) 100 mg
MM 0938.04 Imp. C (EP) as Hydrochloride: 2-Methoxy-5-[(2R)-2-[(2-phenoxyethyl)amino] propyl]benzenesulfonamide Hydrochloride
O
HN
O
SNH2
OO
x HCl
(A) 100 mg
MM 0938.05 Imp. D (EP) as Hydrochloride: 2-Methoxy-5-[(2R)-2-[[2- (2-methoxyphenoxy)ethyl]amino]propyl] benzenesulfonamide Hydrochloride
O
O
HN
O
SNH2
OO
x HCl
(A) 100 mg
MM 0938.06 Imp. E (EP): 5-Formyl-2-methoxybenzene- Sulfonamide O
O
SNH2
OO (A) 50 mg
MM 0938.07 Imp. F (EP) as Hydrochloride: 2-(2-Ethoxy- phenoxy)ethanamine Hydrochloride
O
ONH2 x HCl
(A) 100 mg
MM 0938.01 Imp. H (EP) as Racemate Hydrochloride: (2RS)-N-[2-(2-Ethoxyphenoxy)ethyl]-1- (4-methoxyphenyl)propan-2-amine Hydrochloride
O
O
HN
O
x HCl
(A) 100 mg
MM 0938.09 Imp. I (EP): 1-(2-Bromoethoxy)-2-ethoxybenzene
O
OBr
(A) 100 mg
Telmisartan New MM 0939.01 Imp. A (EP): 4-Methyl-6-(1-methyl-1H-benz-
imidazol-2-yl)-2-propyl-1H-benzimidazole
NH
N
NN
(A) 100 mg
New MM 0939.10 Methyl 4'-(Bromomethyl)biphenyl-2-carboxylate BrO O (A) 100 mg
Temazepam MM 0087.00 Temazepam
[Controlled Substance] N
NO
ClOH
on request
MM 0023.01 Imp. A (EP): [5-Chloro-2-(methylamino)- phenyl]phenylmethanone (5-Chloro-2-(methylamino)benzophenone) Cl
NH
O
(B) 100 mg
MM 0080.00 Imp. B (EP): Oxazepam [Controlled Substance]
N
HN
O
ClOH
(D) 100 mg
Pharmaceutical impurities
198 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Tenoxicam MM 0084.01 Imp. A (EP): Pyridin-2-amine H2N
N
(B) 100 mg
MM 0247.01 Imp. B (EP): Methyl 4-Hydroxy-2-methyl-2H-thieno[2,3-e]1,2-thiazine-3-carboxylate 1,1-Dioxide N
S
OH O
OS
O O (A) 100 mg
MM 0247.04 Imp. C (EP): N-Methylthiophene-2-carboxamide HNS
O
(A) 100 mg
MM 0247.06 Imp. E (EP): 2-Methylthieno[2,3-d]isothiazol-3(2H)-one 1,1-Dioxide
SN
SO O
O
(A) 100 mg
New MM 0247.10 2-(Methoxycarbonyl)-3-thiophenesulfonyl Chloride
OCl
S
O
S
O O (A) 100 mg
Terazosin Hydrochloride Dihydrate MM 0843.00 Terazosin Hydrochloride Dihydrate
N
NO
ONH2
N
N
O
O x HClx 2 H2O
(A) 100 mg
MM 0085.04 Imp. A (EP): 2-Chloro-6,7- dimethoxyquinazolin-4-amine N
NO
ONH2
Cl (A) 100 mg
MM 0843.02 Imp. B (EP): 1-(4-Hydroxy- 6,7-dimethoxyquinazolin-2-yl)-4-[[(2RS)- tetrahydrofuran-2-yl]carbonyl]piperazine
N
NO
OOH
NN
O
O
(A) 100 mg
MM 0085.01 Imp. C (EP): 6,7-Dimethoxy- 2-(piperazin-1-yl)quinazolin-4-amine
N
NO
ONH2
NNH (A) 100 mg
MM 0843.04 Imp. D (EP) as Hydrochloride: 1-(4-Amino-6,7- dimethoxyquinazolin-2-yl)-4-formylpiperazine Hydrochloride
N
NO
O
NH2
N
N
O
x HCl
(A) 100 mg
MM 0085.03 Imp. E (EP): 2,2'-(Piperazine-1,4-diyl)bis(6,7- dimethoxyquinazolin-4-amine)
N
NO
O
NH2
NN N
N
NH2
O
O
(D) 100 mg
MM 0085.00 Imp. K (EP) as Hydrochloride: Prazosin Hydrochloride
N
NO
ONH2
N
N
O
O x HCl
(A) 100 mg
MM 0085.02 Imp. L (EP): 1-(Furan-2-ylcarbonyl)piperazine
HNN
O
O
(A) 100 mg
MM 0085.05 Imp. M (EP): 1,4-Bis(furan-2- ylcarbonyl)piperazine
N
N
O
O
O
O
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 199
Code Product Code Unit
MM 0843.15 Imp. N (EP): 1-[[(2RS)-Tetrahydrofuran-2-yl]carbonyl]piperazine
HNN
O
O
(A) 100 mg
MM 0843.16 Imp. O (EP): 1,4-Bis[(tetrahydrofuran-2-yl)carbonyl]piperazine
NN
O
O
O
O
(A) 100 mg
Terbinafine Hydrochloride MM 0696.00 Terbinafine Hydrochloride
x HClN
(A) 100 mg
MM 0696.02 Imp. A (EP) as Hydrochloride: N-Methyl-C-(naphthalen-1-yl)methanamine Hydrochloride (Secundary Amine Hydrochloride)
x HClNH
(A) 100 mg
MM 0696.03 Imp. B (EP) as Hydrochloride: (2Z)-N,6,6-Trimethyl-N-(naphthalen-1-ylmethyl)hept-2-en-4-yn-1-amine Hydrochloride (cis-Terbinafine Hydrochloride)
x HClN
(D) 100 mg
MM 0696.04 Imp. C (EP) as Hydrochloride: (2E)-N,6,6-Trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine Hydrochloride (trans-iso-Terbinafine Hydrochloride)
Nx HCl
(D) 100 mg
MM 0696.05 Imp. D (EP) as Hydrochloride: (2E)-N,6,6-Trimethyl-N-[(4-methylnaphthalen-1-yl)methyl]-hept-2-en-4-yn-1-amine Hydrochloride (4-Methylterbinafine Hydrochloride
x HClN
(D) 100 mg
MM 0696.07 N-Demethylterbinafine Hydrochloride x HClN
H
(D) 50 mg
New MM 0696.10 Imp. F (EP) as Hydrochloride: (2Z)-N,6,6-Trimethyl-N-(naphthalen-2-ylmethyl)hept-2-en-4-yn-1-amine Hydrochloride (cis-Iso-terbinafine Hydrochloride)
x HClN
(D) 50 mg
Terbutaline Sulphate MM 0708.01 Imp. A (EP): 3,5-Dihydroxybenzoic Acid (�-Resorcylic Acid)
HO
OH
OH
O (B) 100 mg
MM 0708.03 Imp. B (EP) as Hemisulphate: (4RS)-2-(1,1-Dimethylethyl)-1,2,3,4-tetrahydroisoquinoline-4,6,8-triol Hemisulphate
HO
OH
OH
x 1/2 H2SO4N
(D) 100 mg
Terfenadine MM 0055.00 Terfenadine
OH
N
OH
(A) 500 mg
MM 0055.04 Imp. A (EP): 1-[4-(1,1-Dimethylethyl)phenyl]-4-[4-(hydroxydiphenylmethyl) piperidin-1-yl]butan-1-one (Terfenadone)
OH
N
O
(A) 100 mg
MM 0055.07 Imp. B (EP): (1RS)-1-[4-(1,1-Dimethylethyl)phenyl]-4-[4- (diphenylmethyl)piperidin-1-yl]butan-1-ol N
OH
(A) 100 mg
Pharmaceutical impurities
200 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0055.12 Imp. E (EP) as Hydrochloride: 1-[(4RS)-4-[4-(1,1-Dimethylethyl)phenyl]-4-hydroxybutyl]piperidine-4-carboxylic Acid Hydrochloride HO
NOH
O x HCl
(A) 100 mg
MM 0055.09 Imp. G (EP): [1-[4-[4-(1,1-Dimethylethyl)- phenyl]but-3-enyl]piperidin-4- yl]diphenylmethanol
OH
N
(A) 100 mg
MM 0055.10 Imp. H (EP): [1-[4-[4-(1,1-Dimethylethyl)phenyl]butyl]piperidin-4-yl]diphenylmethanol
OH
N
(A) 100 mg
MM 0055.02 Imp. I (EP): Diphenyl(piperidin-4-yl)methanol (Azacyclonol)
OH
NH (B) 100 mg
MM 0055.03 Imp. J (EP): Ethyl 1-[(4RS)-4-[4-(1,1-Dimethylethyl)phenyl]-4-hydroxybutyl]-piperidine-4-carboxylate
ON
OH
O
(A) 100 mg
Testosterone MM 0323.00 Testosterone
O
OH (A) 500 mg
MM 0323.01 Imp. A (EP): Androst-4-ene-3,17-dione (Androstenedione)
O
O (A) 100 mg
MM 0323.02 Imp. B (EP): 3-Ethoxyandrosta-3,5-dien-17-one (Androstenedione Ethylenolether)
O
O (A) 100 mg
MM 0323.03 Imp. C (EP): 17�-Hydroxyandrost-4-en-3-one (Epitestosterone)
O
OH (A) 100 mg
MM 0323.04 Imp. D (EP): Androst-4-ene-3�,17�-diol (�4-Androstenediol)
HO
OH (A) 100 mg
MM 0323.05 Imp. E (EP): 3-Oxoandrost-4-en-17�-yl Acetate (Testosterone Acetate)
O
O
O (A) 100 mg
MM 0565.00 Imp. F (EP): 17�-Hydroxy-5�-androstan-3-one (Androstanolone, Stanolone)
O
OH
H
(A) 250 mg
MM 0323.07 Imp. G (EP): Androsta-1,4-diene-3,17-dione (Androstadienedione)
O
O (A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 201
Code Product Code Unit
MM 0864.00 Imp. H (EP): 17�-Hydroxyandrosta-1,4-dien-3-one (Boldenone)
O
OH (A) 100 mg
MM 0323.12 Imp. I (EP): 17�-Hydroxyandrosta-4,6-dien-3-one (�6-testosterone)
O
OH (A) 100 mg
MM 0323.13 Imp. J (EP): 3-Methoxyandrosta-3,5-dien- 17-one (Androstenedione Methylenolether)
O
O (A) 100 mg
Testosterone Benzoate MM 0493.00 Testosterone Benzoate
O
O
O (D) 250 mg
MM 0323.00 Testosterone
O
OH (A) 500 mg
MM 0278.01 Benzoic Acid OH
O (B) 100 mg
Testosterone Enantate MM 1119.00 Testosterone Enantate
O
O
O (A) 100 mg
MM 0863.08 Imp. B (EP): 3-Oxoandrost-4-en-17�-yl Hexanoate (Testosterone Caproate)
O
O
O (A) 100 mg
MM 0323.00 Imp. D (EP): 17�-Hydroxyandrost-4-en-3-one (Testosterone)
O
OH (A) 500 mg
Testosterone Isocaproate MM 0863.00 Testosterone Isocaproate
O
O
O (A) 100 mg
MM 0323.00 Imp. A (EP): Testosterone
O
OH (A) 500 mg
MM 0323.05 Imp. B (EP): 3-Oxoandrost-4-en-17�-yl Acetate (Testosterone Acetate)
O
O
O (A) 100 mg
Pharmaceutical impurities
202 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0897.00 Imp. C (EP): Testosterone Propionate
O
O
O (A) 100 mg
MM 0863.07 Imp. D (EP): 3-Oxoandrost-4-en-17�-yl 2-Methylpropanoate(Testosterone Isobutyrate)
O
O
O (A) 100 mg
MM 0863.08 Imp. E (EP): 3-Oxoandrost-4-en-17�-yl Hexanoate (Testosterone Caproate)
O
O
O (A) 100 mg
MM 1119.00 Imp. F (EP): Testosterone Enantate
O
O
O (A) 100 mg
MM 0863.09 Imp. G (EP): 3-Oxoandrost-4-en-17�-yl 4-Methylpentanoate (Epitestosterone Isocaproate)
O
O
O (A) 100 mg
Testosterone Propionate MM 0897.00 Testosterone Propionate
O
O
O (A) 100 mg
MM 0323.05 Imp. A (EP): 3-Oxoandrost-4-en-17�-yl Acetate (Testosterone Acetate) O
O
O (A) 100 mg
MM 0863.07 Imp. B (EP): 3-Oxoandrost-4-en-17�-yl 2-Methyl- propanoate (Testosterone Isobutyrate) O
O
O (A) 100 mg
MM 0323.00 Imp. C (EP): Testosterone OH
O
(A) 500 mg
MM 0897.04 Imp. D (EP): 3-Oxoandrosta-1,4-dien-17�-yl Propanoate O
O
O (C) 50 mg
MM 0897.05 Imp. E (EP): 3-Oxoandrosta-4,6-dien-17�-yl Propanoate O
O
O (A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 203
Code Product Code Unit
Tetracaine Hydrochloride MM 0504.00 Tetracaine Hydrochloride
x HClO
O
NH
N(A) 500 mg
MM 0094.03 Imp. A (EP): 4-Aminobenzoic Acid OH
O
H2N
(B) 100 mg
MM 0504.01 Imp. B (EP): 4-(Butylamino)benzoic Acid OH
O
NH
(A) 100 mg
MM 0504.04 Imp. C (EP): Methyl 4-(Butylamino)benzoate O
O
NH
(A) 100 mg
MM 0504.02 Tetracaine N-Oxide O
O
NH
NO (A) 100 mg
Tetracycline Hydrochloride MM 0452.00 Tetracycline Hydrochloride OH O OH O
NH2
O
OH
OH
N
HH x HCl
HO
(A) 500 mg
Tetramisole Hydrochloride MM 0703.00 Tetramisole Hydrochloride
N
N Sx HCl (A) 500 mg
Tetrazepam MM 0091.00 Tetrazepam
[Controlled Substance]N
NO
Cl
(A) 100 mg
MM 0091.06 Imp. B (EP): 7-Chloro-5-cyclohexyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one
N
HN
O
Cl
(A) 100 mg
MM 0091.03 Imp. E (EP): 7-Chloro-5-(cyclohex-1-enyl)-1,3- dihydro-2H-1,4-benzodiazepin-2-one (Nortetrazepam) N
HN
O
Cl
(A) 100 mg
MM 0091.07 Imp. C (EP): 7-Chloro-5-cyclohexyl-1-methyl- 1,3-dihydro-2H-1,4-benzodiazepin-2-one
N
NO
Cl
(A) 100 mg
MM 0091.04 6-Chloro-2-methyl-4-oxo-4H-3,1-benzoxazine
Cl
N
O
O
(A) 100 mg
MM 0091.52 2-Bromo-4'-chloro-2'-(cyclohexylcarbonyl)acetanilide
Cl
NH
O
OBr on request
Pharmaceutical impurities
204 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Tetryzoline Hydrochloride MM 0088.00 Tetryzoline Hydrochloride
NHN
x HCl
(A) 100 mg
MM 0088.03 Imp. A (EP): (1RS)-1,2,3,4-Tetrahydronaphthalene-1-carbonitrile (�-Cyanotetraline)
N (A) 100 mg
MM 0088.02 1,2,3,4-Tetrahydro-1-naphthalenecarboxylic Acid O OH (A) 100 mg
MM 0088.04 Methyl 1,2,3,4-Tetrahydro-1-naphthalenecarboxylate O O (A) 100 mg
MM 0088.05 N-(2-Aminoethyl)-1,2,3,4-tetrahydro- naphthalene-1-yl-carboxamide Hydrochloride ((1,2,3,4-Tetrahydro-1-naphthyl)formyl- ethylenediamine Hydrochloride)
OHN
NH2
x HCl
(A) 100 mg
MM 0088.06 2-(1,2,3,4-Tetrahydro-1-naphthalenyl)-1H-imidazole Hydrochloride NHN
x HCl
(A) 100 mg
Thalidomide MM 0940.00 Thalidomide
N
O
ONH
O
O
(A) 100 mg
Theobromine MM 0577.00 Theobromine
HN
N N
N
O
O (A) 500 mg
Theophylline MM 0176.00 Theophylline
N
N N
HN
O
O (A) 500 mg
MM 0494.00 Imp. A (EP): Caffeine N
N N
N
O
O
(A) 500 mg
MM 0176.03 Imp. B (EP): 3-Methyl-3,7-dihydro-1H-purine-2,6-dione (3-Methylxanthine) HN
N N
HN
O
O (A) 100 mg
MM 0176.02 Imp. C (EP): N-(6-Amino-1,3-dimethyl-2,4- dioxo-1,2,3,4-tetrahydropyrimidin-5-yl)formamide N
NO
O
NH2
HN
O
(A) 100 mg
MM 0176.01 Imp. D (EP): N-Methyl-5-(methylamino)-1H-imidazole- 4-carboxamide (Theophyllidine) N
HHN N
H
N
O (A) 100 mg
MM 0603.00 Imp. F (EP): Etofylline
N
N N
N
O
OOH (A) 500 mg
MM 0176.04 1-Methylxanthine N
NH
NH
N
O
O on request
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 205
Code Product Code Unit
MM 0176.05 7-Methylxanthine HN
NH
N
N
O
O (A) 100 mg
Theophylline-Ethylenediamine MM 0494.00 Imp. A (EP): Caffeine
N
N N
N
O
O
(A) 500 mg
MM 0176.03 Imp. B (EP): 3-Methyl-3,7-dihydro-1H-purine-2,6-dione (3-Methylxanthine) HN
N N
HN
O
O (A) 100 mg
MM 0176.02 Imp. C (EP): N-(6-Amino-1,3-dimethyl-2,4- dioxo-1,2,3,4-tetrahydropyrimidin-5-yl)form- amide
N
NO
O
NH2
HN
O
(A) 100 mg
MM 0176.01 Imp. D (EP): N-Methyl-5-(methylamino)-1H- imidazole-4-carboxamide (Theophyllidine) N
H
HN NH
N
O (A) 100 mg
MM 0603.00 Imp. F (EP): Etofylline
N
N N
N
O
OOH (A) 500 mg
MM 0577.00 Imp. G (EP): Theobromine HN
N N
N
O
O (A) 500 mg
Thiamazole MM 0889.00 Thiamazole
NNH
S (A) 500 mg
MM 0889.02 Imp. B (EP): 1-Methyl-1H-imidazole NN
(B) 100 mg
MM 0889.03 Imp. C (EP): 1-Methyl-2-(methylsulphanyl)-1H-imidazole N
N
S (A) 100 mg
MM 0889.04 Imp. C (EP) as Hydrochloride: 1-Methyl-2-(methylsulphanyl)-1H-imidazole Hydrochloride
NN
S
x HCl(A) 100 mg
Thiamine Hydrochloride MM 0049.00 Thiamine Hydrochloride (Vitamin B1)
N+ N
N
NH2
S
HO
Cl-
x HCl(A) 500 mg
MM 0049.05 Imp. E (EP): 3-[(4-Amino-2-methylpyrimidin-5-yl)methyl]-5-(2-hydroxyethyl)-4-methylthiazol-2(3H)-thione (Thioxothiamine)
N N
N
NH2
S
HO
S (A) 100 mg
MM 0049.02 5-(2-Hydroxyethyl)-4-methylthiazole N
S OH
(A) 100 mg
MM 0049.04 4-Amino-5-hydroxymethyl-2-methylpyrimidine Hydrochloride N
N NH2
OHx HCl
(A) 100 mg
Thiamphenicol MM 0737.00 Thiamphenicol
ClNH
O
Cl OH
SOHOO (A) 500 mg
Thioctic Acid MM 0127.00 Thioctic Acid
S SOH
O (A) 500 mg
Pharmaceutical impurities
206 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Thioridazine Hydrochloride MM 0116.05 2-Methylthiophenothiazine
NHS
S
(A) 100 mg
Tiabendazole MM 0602.00 Tiabendazole
N
HN
N
S(A) 500 mg
MM 0602.01 Imp. A (EP): Benzene-1,2-diamine NH2
NH2 (C) 100 mg
Tiamulin Hydrogen Fumarate MM 0394.00 Tiamulin Hydrogen Fumarate
O
H
HO
O
OS
NOH
O
O
HOx
(A) 100 mg
MM 0460.10 Fumaric Acid OH
HO
O
O (B) 100 mg
MM 0394.04 Imp. A (EP): (3aS,4R,5S,6S,8R,9R,9aR,10R)- 6-Ethenyl-5,8-dihydroxy-4,6,9,10-tetramethyl- octahydro-3a,9-propano-3aH-cyclopentacyclo- octen-1(4H)-one (Mutilin)
O
H
HO
HO(A) 100 mg
New MM 0394.06 Imp. C (EP) as Dihydrochloride: 2,2'-(Disulfane- 1,2-diyl)bis(N,N-diethylethanamine) Dihydrochloride
SS
NN
x 2 HCl
(A) 50 mg
MM 0394.18 Imp. P (EP): (3aS,4R,5S,6S,8R,9R,9aR,10R)-6- Ethenyl-5-hydroxy-4,6,9,10-tetramethyl-1-oxo- decahydro-3a,9-propano-3aH-cyclopentacyclo- octen-8-yl [(Phenylsulphonyl)oxy]acetate
O
H
HO
O
O
OS
O O (A) 50 mg
Tiapride Hydrochloride New MM 0073.01 Imp. C (EP): N,N-Diethylethane-1,2-diamine
H2NN
(B) 100 mg
Ticlopidine Hydrochloride MM 0150.00 Ticlopidine Hydrochloride
N
S
x HCl
Cl
(A) 500 mg
MM 0150.12 Imp. A (EP): Thieno[3,2-c]pyridine N
S (A) 100 mg
MM 0150.06 Imp. B (EP): 6,7-Dihydrothieno[3,2-c]pyridin-4(5H)-one HN
S
O
(A) 100 mg
MM 0150.01 Imp. C (EP) as Hydrochloride: (2-Chloro- phenyl)methanamine Hydrochloride NH2 x HCl
Cl
(A) 100 mg
MM 0150.07 Imp. D (EP) as Hydrochloride: 5-Benzyl-4,5,6,7-tetrahydrothieno[3,2-c]pyridine Hydrochloride N
Sx HCl (A) 100 mg
MM 0150.13 Imp. E (EP) as Chloride: 5-(2-Chlorobenzyl)-thieno[3,2-c]pyridinium Chloride N+
S
Cl-
Cl
(A) 50 mg
New MM 0150.14 Imp. F (EP) as Hydrochloride: 6-(2-Chloro- benzyl)-4,5,6,7-tetrahydrothieno[2,3-c]- pyridine Hydrochloride
N S
Cl
x HCl(A) 50 mg
MM 0150.08 Imp. G (EP) as Hydrochloride: 5-(3-Chlorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine Hydrochloride N
S
Clx HCl
(A) 100 mg
MM 0150.09 Imp. H (EP) as Hydrochloride: 5-(4-Chlorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine Hydrochloride N
SClx HCl
(C) 50 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 207
Code Product Code Unit
MM 0150.11 Imp. I (EP) as Hydrochloride: N-(2-Chlorobenzyl)-2-(thiophen-2-yl)ethanamine Hydrochloride NH
S
x HCl
Cl
(A) 100 mg
MM 0150.10 Imp. J (EP) as Dihydrochloride: N,N'-Bis(2-chlorobenzyl)ethane-1,2-diamine Dihydrochloride NH
NH
Clx 2 HCl
Cl
(A) 100 mg
MM 0150.15 Imp. L (EP): 5-(2-Chlorobenzyl)-6,7-dihydrothieno[3,2-c]pyridin-4(5H)-one N
S
OCl
(A) 50 mg
MM 0150.04 5-(2-Chlorobenzoyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine N
S
OCl
(A) 100 mg
Tilidine Hydrochloride Hemihydrate MM 0134.00 Tilidine Hydrochloride Hemihydrate
[Controlled Substance] x HClx 1/2 H2O
OO
N
and enantiomer
(A) 100 mg
MM 0134.01 Imp. A (EP): Ethyl (1RS,2RS)-2-(Dimethylamino)-1-phenylcyclohex-3-enecarboxylate (cis-Tilidine) [Controlled Substance]
OO
N
and enantiomer
(D) 100 mg
MM 0134.03 Imp. D (EP) as Hydrochloride: Ethyl (2RS)-3-Dimethylamino-2-phenylpropanoate Hydrochloride
x HCl
N
O
O
(A) 100 mg
MM 0134.05 Tilidine [Controlled Substance]
OO
N
and enantiomer
(A) 100 mg
Timolol Maleate MM 0440.00 Timolol Maleate O
OH
O
OHx
NS
N N
O
OHHN
O
(A) 250 mg
MM 0440.04 Imp. D (Pharmeuropa): 4-Morpholin-4-yl- 1,2,5-thiadiazol-3-ol
NS
N N
OH
O
(A) 100 mg
MM 0440.03 N-Benzyl-tert-butylamine
HN
(B) 100 mg
MM 0440.05 3-Hydroxy-4-morpholino-1,2,5-thiadiazole 1-Oxide NS
N N
OH
O
O(A) 100 mg
MM 0440.02 (S)-Isotimolol
NS
N N
O
O
HO NH
(A) 100 mg
Tinidazole MM 0012.02 Imp. A (EP): 2-Methyl-5-nitro-1H-imidazole
(2-Methyl-4-nitroimidazole) NH
N
O2N (B) 100 mg
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Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 209
Code Product Code Unit
Tioconazole MM 0281.01 Imp. D (EP): (1RS)-1-(2,4-Dichlorophenyl)-2-
(1H-imidazol-1-yl)ethanol
N
NHO
Cl
Cl (A) 100 mg
Tiotropium Bromide Monohydrate New MM 1293.05 Imp. E (EP): Methyl 2-Hydroxy-2,2-dithiophen-2-ylacetate
O
O
OH
S
S
(A) 100 mg
MM 1293.06 Imp. F (EP): Dithiophen-2-ylmethanone S
S
O(A) 100 mg
Tizanidine Hydrochloride New MM 0887.04 N-Acetyltizanidine
NS
N
Cl
NH
N
N
O
(A) 50 mg
New MM 0887.05 1-Acetylimidazolidine-2-thione
NH
N
S
O (A) 50 mg
Tolazoline Hydrochloride MM 0585.00 Tolazoline Hydrochloride
HN
Nx HCl
(A) 500 mg
Tolbutamide MM 0325.01 Imp. A (Pharmeuropa): (4-Methylphenyl)-
sulphonamide (Toluenesulphonamide; 4-Methyl- benzenesulphonamide)
SNH2
O O (C) 100 mg
Tolnaftate MM 0731.01 Imp. A (EP): Naphthalen-2-ol (�-Naphthol)
HO
(A) 100 mg
New MM 0731.03 O-Naphthalen-2-yl Chlorothioformate Cl O
S (A) 50 mg
MM 0731.04 Imp. D (EP): N,3-Dimethylaniline (N-Methyl-m-toluidine) NH
(A) 100 mg
Tolmetin Sodium Dihydrate MM 0571.00 Tolmetin Sodium Dihydrate
N ONa
O
O
x 2 H2O
on request
Torasemide, Anhydrous New MM 1283.03 Imp. C (EP): 1-Ethyl-3-[[4-[(3-methylphenyl)amino]-
pyridin-3-yl]sulfonyl]urea N
NH
SNH
O O
NH
O (A) 50 mg
New MM 1283.04 Imp. D (EP): 1-Butyl-3-[[4-[(3-methylphenyl)amino]- pyridin-3-yl]sulfonyl]urea N
NH
SNH
O O
NH
O (A) 50 mg
Pharmaceutical impurities
210 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Tramadol Hydrochloride MM 0007.00 Tramadol Hydrochloride
OHO
Nx HCl
and enantiomer
(A) 500 mg
MM 0007.01 Imp. A (EP) as Hydrochloride: (1RS,2SR)- 2-[(Dimethylamino)methyl]-1-(3-methoxyphenyl)- cyclohexanol Hydrochloride
OHO
Nx HCl
and enantiomer
(A) 100 mg
MM 0007.03 Imp. B (EP) as Hydrochloride: [2-(3-Methoxyphenyl)cyclohex-1-enyl]-N,N-dimethylmethanamine Hydrochloride N
x HCl
O (A) 100 mg
MM 0007.04 Imp. C (EP) as Hydrochloride: (1RS)-[2-(3-Methoxy- phenyl)-cyclohex-2-enyl]-N,N-dimethylmethanamine Hydrochloride N
x HCl
O (A) 100 mg
MM 0007.06 Imp. D (EP) as Hydrochloride: (1RS,2RS)-2- [(Dimethylamino)methyl]-1-(3-hydroxyphenyl)- cyclohexanol Hydrochloride
OHHO
Nx HCl
and enantiomer
(A) 100 mg
MM 0007.02 Imp. E (EP) as Hydrochloride: (2RS)- 2-[(Dimethylamino)methyl]- cyclohexanone Hydrochloride
N x HCl
O (A) 100 mg
MM 0007.05 3-Bromoanisole O Br (B) 100 mg
MM 0007.07 N-Desmethyltramadol Hydrochloride OH
O
NH
and enantiomer
x HCl
(A) 100 mg
MM 0007.08 N,O-Didesmethyltramadol Hydrochloride OH
HO
NH
x HCl
and enantiomer
(A) 100 mg
MM 0007.09 3-Methoxyphenol O OH (B) 100 mg
MM 0007.11 Tramadol N-Oxide OH
O
N
and enantiomer
O
(A) 100 mg
MM 0007.50 [2-(3-Hydroxyphenyl)cyclohex-1-enyl]-N,N-dimethylmethanamine Hydrochloride
Nx HCl
HO (A) 100 mg
Tranexamic Acid MM 0330.00 Tranexamic Acid
OH
O
H2N
(A) 500 mg
MM 0330.04 Imp. D (EP): 4-Aminomethylbenzoic Acid OH
O
H2N
(B) 100 mg
Trazodone Hydrochloride MM 0421.00 Trazodone Hydrochloride
ClNNN
NN
O
x HCl
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 211
Code Product Code Unit
MM 0421.13 Imp. A (BP) as Hydrochloride: 4-(3-Chloro-phenyl)-1-[3-(3-oxo-2,3- dihydro-1,2,4-triazolo[4,3-a] pyridin-2-yl)propyl]piperazine N1-oxide Hydrochloride (Trazodone N-Oxide Hydrochloride)
ClN
NN
NN
O
x HCl
O
(A) 50 mg
New MM 0421.02 Imp. B (BP): 2-[3-(4-Phenylpiperazin-1-yl) propyl]-1,2,4-triazolo[4,3-a]pyridin-3 (2H)-one
N
NN
NN
O
(A) 50 mg
MM 0421.03 Imp. C (BP) as Dihydrochloride: 2-[3-[4-(4-Chlorophenyl)piperazin-1-yl]propyl]-1,2,4-triazolo[4,3-a]pyridin-3(2H)-one Dihydrochloride
N
NN
NN
O
Cl
x 2 HCl
on request
New MM 0421.04 Imp. D (BP) as Hydrochloride: 2-3- [4-(3-Bromo-phenyl)piperazin-1-yl] propyl-1,2,4-triazolo[4,3-a]-pyridin- 3(2H)-one Hydrochloride
N
NN
NN
O
Br x HCl
(A) 50 mg
MM 0421.06 Imp. F (BP) as Hydrochloride: 1-(3-Chlorophenyl)-4-(3-chloropropyl)piperazine Hydrochloride N
NClCl x HCl
(A) 100 mg
New MM 0421.07 Imp. G (BP) as Hydrochloride: 3-[4-(3-Chloro-phenyl)piperazin-1-yl]propyl Isobutyl Ether Hydrochloride
N
NO
Cl x HCl
(D) 50 mg
MM 0421.08 Imp. H (BP) as Dihydrochloride: 1,3-Bis-[4-(3-chloro-phenyl)piperazin-1-yl]propane Dihydrochloride N
NNClNCl
x 2 HCl
(A) 100 mg
MM 0421.10 3-[4-(3-Chlorophenyl)piperazin-1-yl]propanol ClN
NHO
(A) 100 mg
MM 0421.11 1,2,4-Triazolo-[4,3-a]pyridine-3(2H)-one N NH
N
O
(A) 100 mg
MM 0421.12 1,4-Bis-3-chlorophenylpiperazine ClN
NCl
on request
Triacetin MM 0966.00 Triacetin
OO
O
O
O
O (A) 500 mg
Triamcinolone MM 0198.01 Triamcinolone
O
F
OH
OH
OH
O
HO
(A) 250 mg
MM 0198.02 Imp. A (EP): 9-Fluoro-11�,17-dihydroxy-3,20-dioxopregna-1,4-diene-16�,21-diyl Diacetate (Triamcinolone 16,21-Diacetate)
O
F
O
O
OH
O
HO
O
O
(A) 100 mg
MM 0508.03 Imp. C (EP): 9-Fluoro-11�,16�,17,21-tetrahydroxypregn-4-ene-3,20-dione (Pretriamcinolone)
O
F
OH
OH
OH
O
HO
on request
Pharmaceutical impurities
212 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Triamcinolone Acetonide MM 0198.00 Triamcinolone Acetonide
O
HO
F
OO
OOH (A) 250 mg
MM 0198.01 Imp. A (EP): Triamcinolone
O
HO
F
OHOH
OOH (A) 250 mg
MM 0198.02 Triamcinolone 16,21-Diacetate
O
HO
F
OHO
OO
O
O (A) 100 mg
MM 0198.05 Triamcinolone Acetonide 21-Aldehyde Hydrate
O
HO
F
OO
OOH
OH
(A) 100 mg
Triamcinolone Hexacetonide MM 0306.00 Triamcinolone Hexacetonide
O
HO
F
OO
OO
O (A) 100 mg
MM 0198.00 Imp. A (EP): Triamcinolone Acetonide
O
HO
F
OO
OOH (A) 250 mg
MM 0198.01 Triamcinolone
O
HO
F
OHOH
OOH (A) 250 mg
Triamterene MM 0269.00 Triamterene
N
NN
N
NH2
NH2
H2N (A) 500 mg
MM 0269.02 Imp. A (EP): 5-Nitrosopyrimidine-2,4,6-triamine (Nitrosotriaminopyrimidine) N
N
NO
NH2
NH2H2N
(B) 100 mg
MM 0269.01 Sodium Hydroxytriamterene Sulphate N
NN
N
NH2
NH2
H2N
OS
NaO
OO
(B) 10 mg
Tributyl Acetylcitrate MM 0499.00 Tributyl Acetylcitrate O O
OO
O
O
O
O
on request
MM 0499.01 Imp. A (EP): Tributyl 2-Hydroxypropane-1,2,3-tricarboxylate (Tributyl Citrate)
O O
OO
O
O
HO(C) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 213
Code Product Code Unit
MM 0499.02 Imp. B (EP) (E-Isomer): Tributyl (E)-Propene-1,2,3-tricarboxylate (Tributyl (E)-Aconitate)
O OO
O
OO
(A) 100 mg
Triclabendazole MM 0313.00 Triclabendazole
O
N
HN
Cl
Cl
Cl
S
(D) 100 mg
Triclosan MM 0610.00 Triclosan
O
Cl
Cl OH
Cl
(A) 500 mg
Trihexyphenidyl Hydrochloride MM 0237.00 Trihexyphenidyl Hydrochloride
N
OH x HCl
(A) 500 mg
MM 0237.03 Imp. A (EP) as Hydrochloride: 1-Phenyl-3- (piperidin-1-yl)propan-1-one Hydrochloride
O
N x HCl(A) 100 mg
MM 0237.01 Acetophenone O (B) 100 mg
MM 0237.04 Trihexyphenidyl N-Oxide
N
OH O
(C) 50 mg
Trimebutine MM 0417.00 Trimebutine
O
OO
O
O
N
(A) 500 mg
MM 0417.05 Trimebutine Maleate O
O
O
O
O
NOH
O
x
O
OH
(A) 500 mg
MM 0417.01 Imp. A (Pharmeuropa) as Hydrochloride: (2RS)- 2-(Dimethylamino)-2-phenylbutanol Hydrochloride
OHN x HCl
(A) 100 mg
MM 0093.13 Imp. B (Pharmeuropa): 3,4,5-Trimethoxybenzoic Acid OO
OOH
O
(B) 100 mg
MM 0093.11 Imp. C (Pharmeuropa): Methyl 3,4,5-Trimethoxybenzoate O
O
O
O
O
(A) 100 mg
MM 0417.07 Imp. E (Pharmeuropa) as Hydrochloride: (2RS)-2-(Methylamino)-2-phenylbutyl- 3,4,5-Trimethoxybenzoate Hydrochloride (N-Desmethyltrimebutine Hydrochloride)
x HClO
O
O
O
O
HN
(A) 50 mg
MM 0417.10 1-Dimethylaminomethyl-1-phenyl-1-propanol Hydrochloride (alpha-[(Dimethylamino)methyl]-alpha-ethyl-benzenemethanol Hydrochloride)
x HCl
HON (A) 100 mg
MM 0417.11 Imp. D (Pharmeuropa): (1RS)-1-[(Dimethylamino)-methyl]-1-phenylpropyl 3,4,5-Trimethoxybenzoate
O
OO
O
O
N (A) 50 mg
Pharmaceutical impurities
214 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
Trimeprazine Tartrate MM 0958.00 Trimeprazine Tartrate
HO
OH
OH
OH
O
O
N
S
N
x
2
(A) 500 mg
MM 0957.00 Trimeprazine Sulphone (Oxomemazine)
S
N
N
O O
(A) 100 mg
MM 0958.02 Trimeprazine Sulphoxide Hydrochloride
S
N
N
O
x HCl
(A) 100 mg
MM 0958.04 Trimeprazine Sulphone N-Oxide Hydrochloride (Oxomemazine N-Oxide Hydrochloride)
S
N
NO
OO
x HCl
(A) 100 mg
Trimetazidine Dihydrochloride MM 0539.00 Trimetazidine Dihydrochloride
NHN
OO
O
x 2 HCl
(A) 100 mg
MM 0539.01 Imp. A (EP) as Dihydrochloride: 1-(3,4,5- Trimethoxybenzyl)piperazine Dihydrochloride N
HN
O
O
O
x 2 HCl
(A) 100 mg
MM 0539.02 Imp. B (EP): 1,4-Bis(2,3,4-trimethoxy-benzyl)piperazine N
N
OO
O
O
O
O
(A) 100 mg
MM 0539.03 Imp. C (EP): 2,3,4-Trimethoxybenzaldehyde O
OO
O
(B) 100 mg
MM 0539.04 Imp. D (EP): (2,3,4-Trimethoxyphenyl)methanol HO
OO
O
(A) 100 mg
MM 0539.05 Imp. E (EP) as Dihydrochloride: 1-(2,4,5- Trimethoxybenzyl)piperazine Dihydrochloride N
HNO
O
O
x 2 HCl
(A) 100 mg
MM 0539.06 Imp. F (EP) as Dihydrochloride: 1-(2,4,6-Tri- methoxybenzyl)piperazine Dihydrochloride N
HNO
O
O
x 2 HCl
(A) 100 mg
MM 0539.07 Imp. G (EP) as Hexahydrate: Piperazine Hexahydrate NH
HNx 6 H2O (B) 100 mg
MM 0539.09 Imp. H (EP): Ethyl 4-(2,3,4-Trimethoxybenzyl)- piperazine-1-carboxylate N
N
OO
OO
O
(A) 100 mg
MM 0539.10 Imp. I (EP) as Dihydrochloride: 1-Methyl-4- (2,3,4-trimethoxybenzyl)piperazine Dihydrochloride (N-Methyltrimetazidine Dihydrochloride)
NN
OO
O
x 2 HCl
(A) 100 mg
MM 0539.08 1-Formyl-4-(2,3,4-trimethoxybenzyl)piperazine Hydrochloride N
N
O
O
O
x HCl
O
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 215
Code Product Code Unit
Trimethoprim MM 0093.00 Trimethoprim O
O
ON
N NH2
NH2
(A) 500 mg
MM 0093.06 Imp. A (EP): N 2-Methyl-5-(3,4,5-trimethoxybenzyl)pyrimidine-2,4-diamine
OO
ON
N NH
NH2
(A) 100 mg
MM 0093.01 Imp. B (EP): (2,4-Diaminopyrimidin-5-yl)-(3,4,5-trimethoxy-phenyl)methanone
OO
ON
N NH2
NH2O
(A) 100 mg
MM 0093.08 Imp. C (EP): (RS)-(2,4-Diaminopyrimidin-5-yl)(3,4,5-trimethoxy-phenyl)methanol
OO
ON
N NH2
NH2OH
(A) 100 mg
MM 0093.04 Imp. D (EP): 2-Amino-5-(3,4,5-trimethoxybenzyl)pyrimidin-4-ol OO
ON
N NH2
OH
(A) 100 mg
MM 0093.03 Imp. E (EP): 4-Amino-5-(3,4,5-trimethoxybenzyl)pyrimidin-2-ol OO
ON
N OH
NH2
(A) 100 mg
MM 0093.09 Imp. F (EP): 5-(3-Bromo-4,5-dimethoxybenzyl)pyrimidine-2,4-diamine
OO
BrN
N NH2
NH2
(A) 100 mg
MM 0093.10 Imp. G (EP): 5-(4-Ethoxy-3,5-dimethoxybenzyl)pyrimidine-2,4-diamine
OO
ON
N NH2
NH2
(A) 100 mg
MM 0093.11 Imp. H (EP): Methyl 3,4,5-Trimethoxybenzoate OO
OO
O
(A) 100 mg
MM 0093.12 Imp. I (EP): 3-(Phenylamino)-2-(3,4,5-trimethoxy- benzyl)prop-2-enenitrile (E/Z-mixture)
OO
O
HN
N
(A) 100 mg
MM 0093.13 Imp. J (EP): 3,4,5-Trimethoxybenzoic Acid OO
OOH
O
(B) 100 mg
MM 0093.17 Imp. K (EP) as Hydrochloride: Aniline Hydrochloride
NH2x HCl
(B) 100 mg
MM 0093.02 5-(3,4,5-Trimethoxybenzyl)pyrimidin-2,4-diol OO
ON
N OH
OH
(B) 10 mg
MM 0093.05 2-Amino-5-(4-hydroxy-3,5-dimethoxybenzyl)pyrimidin-4-ol OHO
ON
N NH2
OH
(A) 100 mg
MM 0093.07 N4-Methyl-5-(3,4,5-trimethoxybenzyl)pyrimidine-2,4-diamine OO
ON
N NH2
NH
(C) 50 mg
Trimipramine Maleate MM 0240.00 Trimipramine Maleate
O
OH
O
OHNN x
(A) 500 mg
Pharmaceutical impurities
216 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0240.01 Trimipramine
NN
(A) 100 mg
MM 0240.04 Imp. A (EP): (2RS)-3-(10,11-Dihydro-5H-dibenzo- [b,f]azepin-5-yl)-N,N,2-trimethylpropan-1-amine N-oxide (Trimipramine N-Oxide) NN
O
(A) 100 mg
MM 0240.02 Imp. B (EP) as Hydrochloride: (2RS)-3-(10,11- Dihydro-5H-dibenzo[b,f]azepin-5-yl)-N,2-di- methylpropan-1-amine Hydrochloride (Desmethyltrimipramine Hydrochloride)
NH
N x HCl
(A) 100 mg
MM 0077.00 Imp. D (EP) as Hydrochloride: Imipramine Hydrochloride
N x HClN
(A) 500 mg
MM 0076.06 Imp. F (EP): 10,11-Dihydro-5H-dibenzo[b,f]azepine (Iminodibenzyl)
NH
(B) 100 mg
MM 0240.05 Imp. C (EP) as Hydrochloride: (2RS)-3-(5H-Dibenzo[b,f]azepin-5-yl)-N,N,2-trimethylpropan- 1-amine Hydrochloride
NN x HCl
(A) 50 mg
Tropicamide MM 0601.00 Tropicamide
NN
O
OH
(A) 250 mg
MM 0601.01 Imp. A (EP): N-(Pyridin-4-ylmethyl)ethanamine N
HN (A) 100 mg
MM 0601.03 Imp. C (EP): (2RS)-3-Hydroxy-2-phenylpropanoic Acid (Tropic Acid) OH
O
OH
(A) 100 mg
MM 0160.03 Imp. D (Pharmeuropa): Phenylacetic Acid [Drug Precursor]OH
O (B) 100 mg
Tropisetron Hydrochloride MM 0763.01 Imp. A (EP): (1R,3r,5S)-8-Methyl-8-
azabicyclo[3.2.1]oct-3-ol (Tropine) HO
NH
H
H (A) 100 mg
MM 0763.02 Imp. B (EP): 1H-Indole-3-carboxylic Acid OHHN
O (A) 100 mg
Trospium Chloride MM 0783.09 Imp. A (EP): Hydroxydiphenylacetic Acid
(Benzilic Acid) OH
O
OH
(B) 100 mg
Tryptophan MM 0172.00 L-Tryptophan H
N
O
OH
NH2(A) 500 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 217
Code Product Code Unit
MM 0172.09 Imp. A (EP): 3,3'-[Ethylidenebis(1H-indole-1,3-diyl)]bis[(2S)-2-aminopropanoic] Acid (1,1'-Ethylidenebistryptophan)
N
O
OH
NH2
N
NH2
O
HO
(D) 100 mg
MM 0172.03 Imp. D (EP): (S)-2-Amino-3-(5-hydroxy-1H-indol-3-yl)propanoic Acid (5-Hydroxytryptophan)
HN
O
OHNH2
HO
(A) 100 mg
MM 0172.13 N-Acetyltryptophan HN
O
OH
HN
O (A) 100 mg
Tyrosine MM 0634.00 Tyrosine HO
OH
O
NH2 (A) 100 mg
Valaciclovir Hydrochloride MM 0061.02 Imp. A (Pharmeuropa): 2-Amino-1,9-dihydro-6H-purin-6-one (Guanine)
HN
N NH
N
O
H2N
(B) 100 mg
MM 0061.00 Imp. B (Pharmeuropa): 2-Amino-9-[(2-hydroxy- ethoxy)methyl]-1,9-dihydro-6H-purin-6-one (Aciclovir) HN
N N
N
O
H2NO
OH
(A) 500 mg
MM 0619.07 Imp. G (Pharmeuropa): N,N-Dimethylpyridin-4-amine
N
N (A) 100 mg
MM 0061.01 Imp. I (Pharmeuropa): 2-[(2-Amino-6-oxo-1,6- dihydro-9H-purin-9-yl)methoxy]ethyl Acetate HN
N N
N
O
H2NO
O
O
(A) 100 mg
Valproic Acid MM 0751.00 Valproic Acid O
OH
(A) 500 mg
MM 0751.11 Sodium Valproate O
ONa
(A) 500 mg
MM 0751.01 Imp. A (EP): Pentanoic Acid (Valeric Acid) OH
O (C) 100 mg
MM 0751.02 Imp. B (EP): (2RS)-2-Ethylpentanoic Acid OH
O (A) 100 mg
MM 0751.03 Imp. C (EP): (2RS)-2-(1-Methylethyl)pentanoic Acid OH
O (A) 100 mg
MM 0751.04 Imp. D (EP): 2,2-Dipropylpentanoic Acid OH
O (A) 100 mg
MM 0751.05 Imp. E (EP): Pentanamide (Valeramide) NH2
O (A) 100 mg
MM 0751.06 Imp. F (EP): 2-Propylpentanamide NH2
O (A) 100 mg
MM 0751.07 Imp. G (EP): 2,2-Dipropylpentanamide NH2
O (A) 100 mg
Pharmaceutical impurities
218 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0751.08 Imp. H (EP): Pentanenitrile (Valeronitrile) N (C) 100 mg
MM 0751.09 Imp. I (EP): 2-Propylpentanenitrile N (A) 100 mg
MM 0751.10 Imp. J (EP): 2,2-Dipropylpentanenitrile N (A) 100 mg
Vancomycin Hydrochloride MM 0239.00 Vancomycin Hydrochloride
O
HONH2
OOH
HO
HO
O
O
Cl
HO
NH
O
NH
OH
OH
HN O
NH
O
HN
NH2O
O
HN
O
NHOHCl
O
O
OH
x HCl
O
O OH
(A) 100 mg
Venlafaxine Hydrochloride MM 0393.00 Venlafaxine Hydrochloride
O
N
OH
x HCl
on request
MM 0393.02 Imp. A (EP) as Hydrochloride: 2-(4- Methoxyphenyl)-N,N-dimethylethanamine Hydrochloride O
Nx HCl
(A) 100 mg
MM 0393.07 Imp. B (EP) as Hydrochloride: Ethyl (2RS)-3- (Dimethylamino)-2-(4-methoxyphenyl)propanoate Hydrochloride
O
N
O Ox HCl
(A) 100 mg
MM 0393.08 Imp. C (EP) as Hydrochloride: 1-[(1RS)-2-Amino-1-(4-methoxyphenyl)ethyl]cyclohexanol Hydrochloride
O
NH2
OH
x HCl
(A) 100 mg
MM 0393.04 Imp. D (EP) as Hydrochloride: 1-[(1RS)-1-(4- Methoxyphenyl)-2-(methylamino)ethyl]cyclo- hexanol Hydrochloride
O
HN
OH
x HCl
(A) 100 mg
MM 0393.09 Imp. E (EP) as Hydrochloride: (5RS)-5-(4- Methoxyphenyl)-3-methyl-1-oxa-3-azaspiro- [5.5]undecane Hydrochloride
O
N
O
x HCl
(A) 100 mg
MM 0393.10 Imp. F (EP) as Hydrochloride: (2RS)-2- (Cyclohex-1-enyl)-2-(4-methoxyphenyl)- N,N-dimethylethanamine Hydrochloride
O
Nx HCl
(A) 100 mg
MM 0393.11 Imp. H (EP): 1-[(1RS)-1-(4-Methoxyphenyl)- 2-[[2-(4-methoxyphenyl)ethyl]amino]ethyl]- Cyclohexanol
O
HN
OH
O
(A) 50 mg
MM 0393.03 Imp. G (EP) as Hydrochloride: (2RS)-2- Cyclohexyl-2-(4-methoxyphenyl)-N,N- dimethylethanamine Hydrochloride
O
Nx HCl
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 219
Code Product Code Unit
MM 0393.01 O-Desmethylvenlafaxine
HO
N
OH(A) 100 mg
Verapamil Hydrochloride MM 0022.00 Verapamil Hydrochloride
O
O N
O
x HCl
O
N
(A) 500 mg
MM 0022.07 Imp. A (EP) as Dihydrochloride: N,N'-Bis[2-(3,4-dimethoxyphenyl) ethyl]-N,N'-dimethylpropane-1,3-diamine Dihydrochloride
O
O N N O
Ox 2 HCl (A) 100 mg
MM 0022.08 Imp. B (EP) as Hydrochloride: 2-(3,4-Dimethoxyphenyl)-N-methylethanamine Hydrochloride
O
O NHx HCl
(A) 100 mg
MM 0022.09 Imp. C (EP) as Hydrochloride: 2-(3,4- Dimethoxyphenyl)-N,N-dimethylethan- amine Hydrochloride
O
O Nx HCl
(A) 100 mg
MM 0022.02 Imp. D (EP): 3-Chloro-N-[2-(3,4-dimethoxyphenyl)ethyl]-N-methylpropan-1-amine
O
O N Cl
(A) 100 mg
MM 0022.05 Imp. E (EP): (3,4-Dimethoxyphenyl)methanol O
OOH
(B) 100 mg
MM 0022.10 Imp. F (EP) as Hydrochloride: (2RS)-2- (3,4-Dimethoxyphenyl)-5-(methylamino)- 2-(1-methylethyl)pentanenitrile Hydrochloride HN
O
x HCl
O
N
(A) 100 mg
MM 0022.04 Imp. G (EP): 3,4-Dimethoxybenzaldehyde O
O
O (B) 100 mg
MM 0022.11 Imp. H (EP) as Hydrochloride: (2RS)-2-(3,4-Dimethoxyphenyl)-5-[[2-(3,4-dimethoxyphenyl)ethyl](methyl)amino]-2-ethylpentanenitrile Hydrochloride
O
O N
Ox HClO
N
(A) 100 mg
MM 0022.12 Imp. I (EP) as Hydrochloride: (2RS)-2-(3,4-Dimethoxyphenyl)-2-[2-[[2-(3,4-dimethoxy-phenyl)ethyl](methyl)amino]ethyl]-3-methyl-butanenitrile Hydrochloride
NO
O
O
O
x HCl
N (A) 50 mg
MM 0022.21 Imp. J (EP) as Maleate: (2RS)- 2-(3,4-Dimethoxyphenyl)- 5-[[2-(3,4-dimethoxyphenyl)ethyl]amino]- 2-(1-methylethyl)pentanenitrile Maleate (N-Norverapamil Maleate) O
O NH
O
O
N
OH
O
O
OHx
(A) 100 mg
MM 0022.03 Imp. K (EP): (2RS)-2-(3,4-Dimethoxyphenyl)-3-methylbutylnitrile O
N
O (A) 100 mg
MM 0022.13 Imp. L (EP): 1-(3,4-Dimethoxyphenyl)-2- methylpropan-1-one O
O
O (A) 100 mg
Pharmaceutical impurities
220 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0022.15 Imp. N (EP) as Hydrochloride: 5,5'- (Methylimino)bis[2-(3,4-dimethoxy- phenyl)-2-(1-methylethyl) pentanenitrile]Hydrochloride N
O
O
O x HClO
NN
(A) 50 mg
MM 0022.16 Imp. O (EP) as Hydrochloride: (2RS)- 2-(3,4-Dimethoxyphenyl)- 5-[2-[2-(3,4-dimethoxy- phenyl)ethyl](methyl)amino]- 2-propylpentanenitrile Hydrochloride
O
O N
Ox HClO
N
(A) 100 mg
MM 0022.06 Diisopropylhomoveratylcyanide O
N
O (D) 100 mg
MM 0022.18 3,4-Dimethoxyphenylacetonitrile O
O
N
(A) 100 mg
MM 0022.19 Verapamil N-Oxide Hydrochloride O
O N
O
x HCl
O
N
O
(C) 50 mg
Vincamine MM 0519.00 Vincamine
NN
H
OO
HO
(A) 100 mg
Vinpocetine MM 0406.00 Vinpocetine
NN
O
O
H
(D) 100 mg
MM 0406.02 Imp. A (EP): Ethyl (12RS,13aSR,13bSR)-13a- Ethyl-12-hydroxy-2,3,5,6,12,13,13a,13b-octa- hydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]- naphthyridine-12-carboxylate (Ethyl Vincaminate)
NN
H
OO
HO
and enantiomer
(D) 100 mg
MM 0406.01 Imp. B (EP): Methyl (13aS,13bS)-13a-Ethyl- 2,3,5,6,13a,13b-hexahydro-1H-indolo[3,2,1- de]pyrido[3,2,1-ij][1,5]naphthyridine-12- carboxylate (Apovincamine)
NN
O
O
H
(D) 100 mg
Voriconazole New MM 1094.04 Imp. A (Pharmeuropa): 1-(2,4-Difluorophenyl)-
2-(1H-1,2,4-triazol-1-yl)ethanone
NN
N
O
F
F (A) 100 mg
Warfarin Sodium MM 0732.01 Imp. A (EP): (5RS)-3-(2-Hydroxyphenyl)-5-phenylcyclohex-
2-enone OH
O
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 221
Code Product Code Unit
MM 0732.02 Imp. B (EP): 4-Hydroxy-2H-1-benzopyran- 2-one (4-Hydroxycoumarin)
O O
OH
(A) 100 mg
MM 0732.03 Imp. C (EP): (3E)-4-Phenylbut-3-en-2-one (Benzalacetone)
O
(A) 100 mg
Xylazine Hydrochloride MM 0515.00 Xylazine Hydrochloride H
NS
Nx HCl
(A) 500 mg
MM 0102.02 Imp. A (EP): 2,6-Dimethylaniline (2,6-Xylidine) H2N(B) 100 mg
Xylometazoline Hydrochloride MM 0089.00 Xylometazoline Hydrochloride
N
NH
x HCl
(A) 500 mg
MM 0089.07 Imp. A (EP) as Hydrochloride: N-(2- Aminoethyl)-2-[4-(1,1-dimethylethyl)- 2,6-dimethylphenyl]acetamide Hydrochloride
O
NH
NH2x HCl
(A) 100 mg
MM 0089.04 Imp. B (EP): 2-(Chloromethyl)-5-(1,1-dimethylethyl)-1,3-dimethylbenzene
Cl
(A) 100 mg
MM 0089.03 Imp. C (EP): [4-(1,1-Dimethylethyl)-2,6-dimethylphenyl]acetonitrile N
(A) 100 mg
MM 0089.05 Imp. D (EP): 1-(1,1-Dimethylethyl)-3,5-dimethylbenzene (C) 100 mg
MM 0089.02 Imp. F (EP): [4-(1,1-Dimethylethyl)-2,6-dimethylphenyl]acetic Acid O
OH
(A) 100 mg
Zaleplon New MM 1322.02 N-[3-[3-(Dimethylamino)-1-oxo-2-propenyl]phenyl]-N-ethylacetamide
O
N
O
N
(A) 100 mg
Zidovudine MM 0534.00 Imp. A (EP): 1-[(2R,5S)-5-(Hydroxymethyl)-2,5-dihydrofuran-2-yl)-
5-methylpyrimidine-2,4(1H,3H)-dione (Stavudine)
O
HON
HN
O
O (A) 100 mg
MM 0173.02 Imp. B (EP): 1-(3-Chloro-2,3-dideoxy-�-D- erythro-pentofuranosyl)-5-methylpyrimidine- 2,4(1H,3H)-dione
O
HON
HN
O
O
Cl
(A) 100 mg
MM 0534.01 Imp. C (EP): 5-Methylpyrimidine-2,4(1H,3H)dione (Thymine)
NH
HN
O
O (A) 100 mg
Pharmaceutical impurities
222 All your needs for pharmaceutical analysis - email [email protected] Edition 2011
Code Product Code Unit
MM 0173.04 Imp. D (EP): Triphenylmethanol OH
(A) 100 mg
New MM 0534.03 Thymidine
O
HON
HN
O
O
OH
(A) 100 mg
Zileuton MM 1297.03 1-Benzo-[b]thien-2-ylethanone
S
O (A) 100 mg
Zolpidem Tartrate MM 0333.01 Imp. A (EP): N,N-Dimethyl-2-[7-methyl-
2-(4-methylphenyl)imidazo[1,2-a]pyridin-3-yl]acetamide
N
N
N
O
(D) 100 mg
MM 0333.02 2-[6-Methyl-2-(4-methylphenyl)imidazo-[1,2-a]pyridin-3-yl]acetamide
N
N
NH2
O
(A) 100 mg
MM 0333.03 2-[6-Methyl-2-(4-methylphenyl)imidazo-[1,2-a]pyridin-3-yl]acetic Acid
N
N
OH
O
(A) 100 mg
MM 0333.04 Methyl 2-[6-Methyl-2-(4-methylphenyl)imidazo[1,2-a]pyridin-3-yl]acetate
N
N
O
O
(D) 50 mg
MM 0333.05 6-Methyl-2-(4-methylphenyl)imidazo-[1,2-a]pyridine-3-acetonitrile
N
N
N
(A) 100 mg
MM 0333.06 Oxozolpidem (N,N,6-Trimethyl-2-(4-methylphenyl)-�-oxo- imidazo [1,2-a]pyridine-3-acetamide)
N
N
N
O
O
(D) 100 mg
MM 0333.07 Zolpaldehyde (6-Methyl-2-(4-methylphenyl)-imidazo[1,2-a]pyridine-3-carboxaldehyde)
N
N
O
(A) 100 mg
MM 0333.08 Zolpyridine (4-Methyl-N-(5-methyl-2-pyridinyl)-benzamide) HN
ON
(A) 100 mg
MM 0333.09 6-Methyl-2-(4-methylphenyl)-�-oxo-imidazo[1,2- a]pyridine-3-acetamide
N
N
NH2
O
O
(A) 100 mg
MM 0333.10 Methyl �-Hydroxy-6-methyl-2-(4-methylphenyl)- imidazo[1,2-a]pyridine-3-acetate
N
N
O
O
HO
(A) 100 mg
Pharmaceutical impurities
Edition 2011 Looking for the latest impurities? See www.lgcstandards.com/newimpurities 223
Code Product Code Unit
Zopiclone MM 0149.00 Zopiclone
N
Cl
NN
NO
O
O
N
N
(D) 100 mg
MM 0149.01 Imp. A (EP): (5RS)-6-(5-Chloropyridin-2-yl)-7-oxo-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-yl 4-Methylpiperazine-1-carboxylate 4-Oxide (Zopiclone Oxide) N
Cl
NN
NO
O
O
N
NO
(D) 100 mg
MM 0149.02 Imp. B (EP): (7RS)-6-(5-Chloropyridin-2-yl)-7-hydroxy-6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5-one
N
Cl
NN
NO
HO (D) 100 mg
MM 0149.04 2-Amino-5-chloropyridine N
Cl
H2N
(A) 250 mg
MM 0149.05 3-(5-Chloropyridine-2-carbamoyl)-2-pyrazinecarboxylic Acid
N
Cl
NH
ON
NOH
O
on request
MM 0149.06 6-(5-Chloropyridin-2-yl)- 6,7-dihydro-5H-pyrrolo[3,4-b]pyrazin-5,7-dione
N
Cl
NN
NO
O (A) 100 mg
MM 0149.07 5-(Chloropyridine-2-yl-carbamoyl)pyrazine
N
NNH
O
N
Cl (A) 100 mg
MM 0149.50 2-Acetylamino-5-chloropyridine
NH
O
N
Cl (A) 100 mg
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