list of european pharmacopoeia reference standards · pdf filelist of european pharmacopoeia...

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Code

Reference Standard Batch n° Quantity per

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Unit

Information Monograph Leaflet Storage Extra

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Y0001484 Medroxyprogesterone acetate for peak identification 1 25 mg 1 0673 Yes +5°C a

Y0001523 Ursolic acid 1 25 mg 1 94.0 % C–ÐH÷‡O– 2439 Yes +5°C a

Y0001532 Norethisterone acetate for system suitability 1 2.585 mg 1 0850 Yes +5°C a

Y0001562 Doxylamine hydrogen succinate 1 60 mg 1 1589 +5°C a

Y0001565 Recombinant Major Allergen rBet v 1 1 0.01025 mg 1 10.25 micrograms of rBet v 1 1063 Yes -20°C c

Y0001566 Recombinant Major Allergen rPhl p 5a 1 0.00856 mg 1 8.56 micrograms of rPhl p 5a 1063 Yes -20°C c

Y0001567 Docusate sodium 1 10 mg 1 1418 +5°C a

Y0001570 Nitrofural impurity B 1 30 mg 1 94.8 % C„H„OŸN; (5-nitrofuran-2-yl)methylene diacetate 1135 Yes +5°C a

Y0001571 Naloxone impurity D 1 25 mg 1 0729 Yes +5°C a

New Y0001572 Atovaquone 1 270 mg 1 99.3% CœœHŒ„ClO– 2192 Yes +5°C g

New Y0001573 Atovaquone for system suitability 1 10 mg 1 2192 Yes +5°C g

Y0001574 Mesalazine for system suitability 1 10 mg 1 1699 Yes +5°C a

Y0001575 Bupivacaine impurity F 1 70 mg 1 2,6-dimethylaniline 0541 +5°C g

New Y0001576 Oxcarbazepine 1 120 mg 1 99.8 % Yes +5°C a

Y0001577 Isoprenaline impurity A 1 15 mg 1 1-(3,4-dihydroxyphenyl)-2-[(1-methylethyl)amino]ethanone 1332 +5°C a

Y0001580 Rocuronium bromide 1 10 mg 1 1764 +5°C g

Y0001585 Cellulose acetate butyrate 1 60 mg 1 +5°C a

Y0001609 Norflurane - reference spectrum 1 1 mg 1

Y0001561 Abacavir sulfate 1 20 mg 1 2589 +5°C a

Y0001551 Abacavir for system suitability 1 10 mg 1 2589 Yes +5°C a

Y0001552 Abacavir for peak identification 1 10 mg 1 2589 Yes +5°C a

Y0000055 Acamprosate calcium - reference spectrum 1 n/a 1 1585 l

Y0000116 Acamprosate impurity A 1 50 mg 1 3-aminopropane-1-sulphonic acid 1585 +5°C a

Y0000500 Acarbose 2 94.7 mg 1 94.7 mg Cœ—H÷–NOŒ‡ 2089 +5°C a

Y0000354 Acarbose for identification 1 10 mg 1 2089 +5°C a

Y0000427 Acarbose for peak identification 2 20 mg 1 Batch 1 is valid until 1 May 2013 2089 Yes +5°C a

A0040000 Acebutolol hydrochloride 1 50 mg 1 0871 +5°C a

Y0000359 Acebutolol impurity B 2 10 mg 1 -[3-acetyl-4-[(2RS)-2-hydroxy-3-[(1-methylethyl)amino] propoxy]phenyl]acetamide (diacetolol)

0871 +5°C a

Y0000127 Acebutolol impurity C 1 20 mg 1 N-(3-acetyl-4-hydroxyphenyl)butanamide 0871 +5°C a

Y0000128 Acebutolol impurity I 2 0.004 mg 1 N-[3-acetyl-4-[(2RS)-3-(ethylamino)-2-hydroxypropoxy]phenyl]butanamide

0871 +5°C a

Y0000056 Aceclofenac - reference spectrum 1 n/a 1 1281 l

Y0001094 Aceclofenac for peak identification 1 10 mg 1 1281 Yes +5°C g

Y0000085 Aceclofenac impurity F 1 20 mg 1 benzyl[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetate 1281 +5°C g

Y0000086 Aceclofenac impurity H 1 10 mg 1 [[[[[[[2-[(2,6-dichlorophenyl)amino]phenyl]acetyl]oxy]acetyl] oxy]acetyl]oxy]acetic acid

1281 +5°C g

Effective from: April 2, 2013

List of European Pharmacopoeia Reference Standards

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Y0000810 Acemetacin 1 100 mg 1 1686 +5°C g

Y0000811 Acemetacin impurity A 1 10 mg 1 4-chlorobenzoic acid 1686 +5°C a

Y0000842 Acemetacine impurity mixture 1 0.06 mg 1 1686 Yes +5°C g

A0070000 Acesulfame potassium 2 50 mg 1 1282 +5°C a

A0070020 Acesulfame potassium impurity B 3 50 mg 1 5-chloro-6-methyl-1,2,3-oxathiazin-4(3§)-one 2,2-dioxide 1282 Yes +5°C a

A0100000 Acetazolamide 1 100 mg 1 0454 +5°C a

Y0001084 Acetazolamide for system suitability 1 0.0068 mg 1 0454 Yes +5°C a

Y0000002 Acetylcholine chloride 1 50 mg 1 1485,1971 -20°C c

A0150000 Acetylcysteine 3 50 mg 1 0967 +5°C a

A0152000 Acetylcysteine impurity C 8 10 mg 1 88.5% CŒÐHŒÿNœOÿSœ; N,N'-diacetyl-L-cystine 0967 Yes +5°C a

A0153000 Acetylcysteine impurity D 5 10 mg 1 N,£-diacetyl-L-cysteine 0967 +5°C a

Y0000565 ß-Acetyldigoxin 2 50 mg 1 98.6% C÷–HÿÿOŒ— 2168 +5°C f

Y0000642 ß-Acetyldigoxin for peak identification 1 10 mg 1 2168 Yes +5°C f

A0200000 Acetylsalicylic acid 4 15 mg 1 0309 +5°C a

Y0001460 Acetylsalicylic acid for peak identification 1 10.26 mg 1 0309 Yes +5°C a

A0208000 N-Acetyltryptophan 2 125 mg 1 1383 +5°C a

A0202000 N-Acetyltyrosine 1 200 mg 1 1384 +5°C a

Y0001462 Acetylsulfadiazine 1 0.002 mg 1 0294 +5°C a

Y0000693 Acholeplasma laidlawii BRP 1 1 ml 1 20607 Yes -80°C d

A0220000 Aciclovir 3 75 mg 1 0968 +5°C a

Y0001271 Aciclovir for peak identification 1 2 0.303 mg 1 Batch 1 is valid until 31 August 2012 0968 Yes +5°C a

Y0001269 Aciclovir for peak identification 2 2 0.004 mg 1 Batch 1 is valid until 30 September 2012 0968 Yes +5°C a

Y0001264 Aciclovir for system suitability 1 10 mg 1 0968 +5°C a

A0225000 Acitretin 2 100 mg 1 99.7% CœŒHœÿO– 1385 +5°C g(b)

Y0001464 Actaea racemosa dry extract for system suitability HRS 1 1200 mg 1 2069 Yes -20°C c

Y0001543 Actaea racemosa for assay CRS 1 300 mg 1 74.7% C÷œHÿ—NOŒÿ; Monoammonium glycyrrhizate 2069 Yes +5°C a

Y0001463 Actaea racemosa HRS 1 1200 mg 1 2069 Yes +5°C a

Y0001121 Adapalene 1 100 mg 1 99.9% Cœ‡Hœ‡O– 2445 +5°C a

Y0001120 Adapalene impurity C 2 6 mg 1 1-[2-(methyloxy)phenyl]tricyclo[3.3.1.1]decane 2245 +5°C a

Y0001119 Adapalene for peak identification 1 2.022 mg 1 2445 Yes +5°C a

A0230000 Adenine 2 50 mg 1 0800,1486 +5°C g

A0230200 Adenosine 1 50 mg 1 1486 +5°C a

Y0000110 Adipic acid 1 50 mg 1 1586 +5°C a

Y0000882 Adrenaline 1 5 mg 1 2303 +5°C g

A0300000 Adrenaline tartrate 5 100 mg 1 0254, 0285,

0732

+5°C f

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Y0000740 Adrenaline impurity mixture 2 0.005 mg 1 Batch 1 is valid until 30 April 2012 0254,2303 Yes +5°C f

Y0000707 Adrenaline tartrate with impurity A 1 15 mg 1 0254 Yes +5°C f

Y0000883 Adrenaline with impurity F 1 10 mg 1 2303 Yes +5°C g

Y0000728 Agnus castus fruit standardised dry extract 1 200 mg 1 0.13% CŒ„HŒ‡O‡ 2147 Yes -20°C c

A0325000 Alanine 3 60 mg 1 0614,0752 +5°C a

A0325100 Albendazole 1 50 mg 1 1386 +5°C g

A0325200 Alcuronium chloride 2 50 mg 1 1285 -20°C g(c)

A0325450 Alfacalcidol 8 5 mg 1 99.8% CœŸH÷÷Oœ ; Batch 7 is valid until 31 December 2012 1286 Yes -20°C e(d)

A0325451 Alfacalcidol - reference spectrum 1 n/a 1 1286 l

A1225000 Alfadex 3 150 mg 1 89.7% [CÿHŒÐ0—]ÿ 1070,1487 +5°C a

A0325500 Alfentanil hydrochloride - reference spectrum 1 n/a 1 1062 l

A0325800 Alfuzosin hydrochloride 2 10 mg 1 1287 +5°C a

Y0000832 Alfuzosin for system suitability 1 10 mg 1 1287 Yes +5°C a

A0349000 Allantoin 1 60 mg 1 1288 +5°C a

A0350000 Allopurinol 2 100 mg 1 99.9% C—H÷N÷O 0576 Yes +5°C g

A0350010 Allopurinol impurity A 2 10 mg 1 5-amino-1H-pyrazole-4-carboxamide 0576 +5°C g

A0350020 Allopurinol impurity B 3 10 mg 1 5-formylamino-1H-pyrazole-4-carboxamide ; Batch 2 is valid until 31December 2012

0576 +5°C g

A0350030 Allopurinol impurity C 3 10 mg 1 5-(4H-1,2,4-triazol-4-yl)-1H-pyrazole-4-carboxamide ; Batch 2 is valid until 1May 2013

0576 +5°C g

A0350040 Allopurinol impurity D 3 15 mg 1 ethyl 5-amino-1H-pyrazole-4-carboxylate 0576 +5°C g

G0400000 Glycerol (85 per cent) - reference spectrum 1 n/a 1 0496,0497 l

A0350050 Allopurinol impurity E 1 20 mg 1 ethyl 5-(formylamino)-1H-pyrazole-4-carboxylate 0576 +5°C g

A0351000 Allylstrychnine bromide 1 10 mg 1 1285 -20°C g(c)

H0215000 Hepatitis C Virus RNA for NAT testing BRP 1 40 mg 5 HCV-RNA content 500 IU per vial; For plasma pool testing by NAT See leaflet,

20621

Yes -20°C e(d)

Y0000235 Almagate 1 25 mg 1 13.4% carbonic acid 2010 +5°C a

Y0000255 Almagate - reference spectrum 1 n/a 1 2010 l

A0357000 Alprazolam - * psy 2 100 mg 1 1065 +5°C j

A0360000 Alprenolol hydrochloride 1 100 mg 1 0628,0876 +5°C a

Y0000054 Alprostadil 2 50 mg 1 99.4% CœÐH–÷O— ; Batch 1 is valid until 31 January 2013 1488 Yes -20°C g(c)

Y0000606 Altizide 2 150 mg 1 99.9% CŒŒHŒ÷ClN–O÷S– 0370,2185 +5°C a

Y0000843 Altizide impurity B 1 15 mg 1 3-[(2,2-dimethoxyethyl)sulphanyl]prop-1-ene 2185 +5°C a

Y0000687 Alverine citrate 1 5 mg 1 2156 +5°C a

Y0000595 Alverine for peak identification 1 0.125 mg 1 2156 Yes +5°C a

Y0000607 Alverine impurity D 1 10 mg 1 N-(3-cyclohexylpropyl)-N-ethyl-3-phenylpropan-1-amine 2156 +5°C a

A0363000 Amantadine hydrochloride 1 100 mg 1 0463 +5°C a

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A0363700 Ambroxol hydrochloride 3 125 mg 1 1489 +5°C a

A0900000 Amfetamine sulfate - reference spectrum 1 n/a 1 0368 l

A0365000 Amidotrizoic acid dihydrate 1 100 mg 1 0873 +5°C a

Y0001461 Amidotrizoic acid for system suitability 1 0.08 mg 1 0873 Yes +5°C a

A0368000 Amikacin 3 200 mg 1 91.7 % CœœH÷–N—OŒ– ; Batch 2 is valid until 28 February 2013 1289,1290 Yes +5°C a

Y0001467 Amikacin impurity I 1 20 mg 1 (2S)-4-amino-2-hydroxybutanoic acid 1290 +5°C a

A0365900 Amikacin sulfate 3 200 mg 1 The batch 3 is not suitable for use in the assay in monograph 1290:07/2012. Amikacin CRS A0368000 is also needed. See leaflet.

1290 Yes +5°C a

Y0001117 Amikacin for system suitability 2 10 mg 1 amikacin for system suitability CRS 1 is suitable for 01/2010:1289 and01/2010:1290 only. Batch 2 is suitable for 07/2012:1289 and 07/2012:1290. ; Batch 1 is valid until 30 June 2012

1289,1290 Yes +5°C a

A0370000 Amiloride hydrochloride 1 100 mg 1 0651 +5°C g

New Y0000020 Amiloride impurity A 3 20 mg 1 methyl-3,5-diamino-6-chloropyrazine-2-carboxylate ; Batch 2 is valid until 31August 2013

0651 +5°C g

Y0000173 4-Aminobenzoic acid 2 60 mg 1 1687 +5°C a

A0420000 Aminocaproic acid 1 50 mg 1 0874 +5°C a

A0460000 7-Aminodesacetoxycephalosporanic acid 2 20 mg 1 Cefadroxyl impurity B 0708,0813 +5°C a

A0496000 Aminoglutethimide 1 125 mg 1 1291 +5°C a

A0496005 Aminoglutethimide impurity A 1 20 mg 1 (3¢£)-3-(3-aminophenyl)-3-ethylpiperidine-2,6-dione; (3-aminoglutethimide) 1291 +5°C a

A0496020 Aminoglutethimide impurity D 1 10 mg 1 3,3'-[diazenediyldi(4,1-phenylene)]bis(3-ethylpiperidine-2,6-dione); (azoglutethimide)

1291 +5°C a

A0575000 Amiodarone hydrochloride 3 100 mg 1 0803 +5°C g(b)

Y0000129 Amiodarone impurity D 3 20 mg 1 (2-butyl-benzofuran-3-yl)-(4-hydroxy-3,5-diiodophenyl)methanone 0803 +5°C g

Y0000130 Amiodarone impurity E 3 20 mg 1 (2-butylbenzofuran-3-yl)(4-hydroxyphenyl)methanone ; Batch 2 is valid until31 August 2012

0803 +5°C g

A0590000 Amisulpride 2 10 mg 1 Batch 1 is valid until 31 May 2012 1490 +5°C a

Y0001534 Amisulpride for system suitability 1 1.0015 mg 1 1490 +5°C a

A0590004 Amisulpride impurity B 1 10 mg 1 4-amino-N-[[(2RS)-1-ethylpyrrolidin-2-yl]methyl]-5-(ethyl sulphonyl)-2- hydroxybenzamide

1490 +5°C a

Y0000563 Amitriptyline hydrochloride 1 10 mg 1 0464 +5°C g

Y0000049 Amlodipine besilate 4 150 mg 1 99.7% CœÿH–ŒClNœO‡S 1491 Yes +5°C g

New Y0001067 Amlodipine for peak identification 2 15 mg 1 Batch 1 is valid until 31 August 2013 1491 Yes +5°C g

Y0001068 Amlodipine impurity A 2 15 mg 1 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 ; Batch 1 is valid until 1 June 2013

1491 Yes +5°C g

Y0001069 Amlodipine impurity B 1 10 mg 1 3-ethyl 5-methyl (4RS)-4-(2-chlorophenyl)-6-methyl-2-[[2-[[2- (methylcarbamoyl)benzoyl]amino]ethoxy]methyl]-1,4-dihydropyridine-3,5- dicarboxylate

1491 +5°C g

Y0001070 Amlodipine impurity G 2 15 mg 1 dimethyl 4-(2-chlorophenyl)-2,6-dimethyl-1,4-dihydropyridine-3,5- dicarboxylate ; Batch 1 is valid until 1 June 2013

1491 +5°C g

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Y0000302 Ammonio methacrylate copolymer(type A) - reference spectrum 1 n/a 1 2081 l

Y0000303 Ammonio methacrylate copolymer(type B) - reference spectrum 1 n/a 1 2082 l

A0650000 Amobarbital - * psy 1 500 mg 1 0594 +5°C j

A0700000 Amobarbital sodium - * psy 1 500 mg 1 0166 +5°C j

A0800000 Amoxicillin trihydrate 5 200 mg 1 86.2% CŒÿHŒ„N–O—S 0167,0168,02

60,

0577,0578,08

13, 1140,1653

+5°C a

Y0000005 Amphotericin B 4 100 mg 1 Batch 4 is not suitable for microbiological assay (see leaflet). 1292 Yes -20°C c

Y0001014 Amphotericin B for peak identification 2 10 mg 1 Batch 1 is valid until 1 June 2013 1292 Yes -20°C c

Y0001361 Amphotericin B for microbiological assay 1 100 mg 1 944 IU per mg 20702 Yes -20°C c

A1000000 Ampicillin (anhydrous) 4 250 mg 1 97.6% CŒÿHŒ„N–O÷S 0167,0168,05

78, 1168,1169

+5°C a

A1100000 Ampicillin trihydrate 2 150 mg 1 0168,0260,05

77,

0578,0808,22

11, 2212

+5°C a

Y0001522 Anastrozole 1 100 mg 1 2406 Yes +5°C a

Y0001531 Anastrozole impurity E 1 10 mg 1 2,2'-[5-(hydroxymethyl)benzene-1,3-diyl]bis(2-methylpropanenitrile) 2406 +5°C a

Y0001386 Angelica dahuria root 1 160 mg 1 2556 Yes +5°C a

A1200000 Anhydrotetracycline hydrochloride 4 15 mg 1 93.3% CœœHœœNœOŸ 0210,0211,16

54

+5°C a

Y0001244 Amylmetacresol 1 285 mg 1 99.5% CŒœHŒ‡O 2405 Yes +5°C g

Y0001245 Amylmetacresol for peak identification 1 10 mg 1 2405 Yes +5°C g

Y0001466 Anhydrous Docetaxel 1 15 mg 1 2593 +5°C a

A1210000 Antazoline hydrochloride 1 50 mg 1 0972 +5°C a

A1220000 Alpha-apo-oxytetracycline 4 20 mg 1 0198 +5°C g

Y0001465 Apomorphine hydrochloride hemihydrate 1 15 mg 1 0136 +5°C a

Y0001471 Apomorphine impurity B (morphine sulfate) * - narc 1 40 mg 1 88.2% C–÷H÷ÐNœOŒÐS,5HœO; morphine sulfate 0136 Yes +5°C k

A1230000 Beta-apo-oxytetracycline 5 20 mg 1 88,0% CœœHœœNœO‡ ; Batch 4 is valid until 31 July 2012 0198 Yes +5°C g

A1250000 Aprotinin solution BRP 3 0.5 ml 1 22.3 Ph. Eur. Units per ml 0579,0580 Yes +5°C a

Y0001154 Aprotinin for system suitability 1 2.7 mg 1 0580 Yes +5°C a

A1269000 L-Arabinitol 1 10 mg 1 1381 +5°C a

Y0000806 Arbutin 1 100 mg 1 93.5% CŒœHŒÿOŸ 1054 +5°C a

A1270000 Arginine 3 50 mg 1 99.8% CÿHŒ÷N÷O; Arginine CRS 2 is suitable for monographs 01/2008:0806,04/2008:1654, 01/2008:2114 and 01/2008:0930 only

0806,0930,16

54, 2114

Yes +5°C a

Y0000304 Arginine aspartate 1 20 mg 1 2096 +5°C a

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A1271000 Arginine hydrochloride 2 50 mg 1 0805,0885,09

98

+5°C a

Y0001323 Aristolochia 1 140 mg 1 20821 Yes +5°C g

Y0001185 Aristolochic acid I 1 1 mg 1 1.00 mg CŒŸHŒŒNOŸ 20821 Yes +5°C g

Y0001175 Aristolocholic acid for system suitability 1 1 mg 1 20821 Yes +5°C g

Y0000079 Articaine hydrochloride 2 100 mg 1 1688 +5°C a

Y0000080 Articaine impurity A 2 15 mg 1 methyl3-[[2-(propylamino)acetyl]amino]-4-methylthiophene-2- carboxylate 1688 +5°C a

Y0000081 Articaine impurity E 1 10 mg 1 methyl 4-methyl-3-[[(2RS)-2-[(1-methylethyl)amino]propanoyl]amino]thiophene-2-carboxylate

1688 +5°C a

A1300000 Ascorbic acid 4 100 mg 1 Vitamin C ; Batch 3 is valid until 31 December 2012 0253,1791 +5°C a

Y0001024 Ascorbic acid impurity C 2 20 mg 1 D-xylo-hex-2-ulosonic acid (D-sorbosonic acid) 0253,1791 +5°C a

Y0001170 Ascorbic acid impurity D 2 10 mg 1 methyl D-xylo-hex-2-ulosonate (methyl D-sorbosonate) ; Batch 1 is valid until31 December 2012

0253,1791 +5°C a

Y0000800 Ascorbyl palmitate 1 10 mg 1 0807 +5°C a

Y0000305 Asparagine monohydrate 1 60 mg 1 2086 +5°C a

A1320000 Aspartame 2 40 mg 1 0973 +5°C a

A1321000 Aspartame impurity A 4 10 mg 1 2-(5-benzyl-3,6-dioxopiperazin-2-yl) acetic acid (diketopiperazine) 0973 +5°C a

A1330000 Aspartic acid 2 50 mg 1 0750,0797 +5°C a

Y0001171 Astragaloside IV 1 40 mg 1 2435 -20°C c

A1340000 Atenolol 3 100 mg 1 0703 +5°C a

Y0001089 Atenolol for system suitability 1 5 mg 1 0703 Yes +5°C a

Y0001327 Atorvastatin calcium trihydrate 1 150 mg 1 95.2% CÿÿHÿ‡CaFœN÷OŒÐ 2191 Yes +5°C a

Y0001328 Atorvastatin impurity A 1 10 mg 1 desfluoroatorvastatin 2191 +5°C a

Y0001329 Atorvastatin impurity B 1 10 mg 1 3-epi-atorvastatin 2191 +5°C a

Y0001330 Atorvastatin impurity C 1 10 mg 1 fluoroatorvastatin 2191 +5°C a

New Y0001331 Atorvastatin impurity D 2 10 mg 1 3-[(4-fluorophenyl)carbonyl]-2-(2-methylpropanoyl)-N,3-diphenyloxirane-2- carboxamide ; Batch 1 is valid until 31 August 2013

2191 +5°C a

Y0001332 Atorvastatin impurity E 2 10 mg 1 ent-atorvastatin ; Batch 1 is valid until 28 February 2013 2191 +5°C a

Y0000424 Atracurium besilate 2 120 mg 1 98.5% Cÿ—H‡œNœOŒ‡Sœ ; Batch 1 is valid until 30 April 2012 1970 Yes +5°C g(b)

Y0000105 Rutoside trihydrate 3 100 mg 1 87.6% CœŸH–ÐOŒÿ 1795,1874,21

84,

Yes +5°C a

Y0000503 Atracurium for impurity F identification 1 5 mg 1 1970 Yes +5°C g(b)

Y0000504 Atracurium for peak identification 1 5 mg 1 1970 Yes +5°C g(b)

Y0000878 Atropine 1 30 mg 1 2056 +5°C g

Y0000845 Atropine for peak identification 2 0.25 mg 1 Batch 1 is valid until 31 January 2013 0068,2056 Yes +5°C g

Y0000816 Atropine impurity B 1 10 mg 1 (1R,3r,5S)-8-azabicyclo[3.2.1]oct-3-yl (2RS)-3-hydroxy-2-phenylpropanoate(noratropine)

0068,2056 +5°C g

New A1400000 Atropine sulfate 4 20 mg 1 Batch 3 is valid until 31 August 2013 0068 +5°C g

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Y0000029 Azaperone 1 50 mg 1 1708 +5°C a

A1500000 Azathioprine 1 100 mg 1 0369 +5°C a

Y0001240 Azathioprine impurity A 1 10 mg 1 1-methyl-4-nitro-1H-imidazol-5-amine 0369 +5°C a

Y0001246 Azathioprine impurity G 2 5 mg 1 6-[(1-methyl-4-nitro-1H-imidazol-5-yl)sulfanyl]-7H-purin-2-amine(thiamiprine) ; Batch 1 is valid until 30 April 2012

0369 +5°C a

Y0000326 Azelastine hydrochloride 1 25 mg 1 1633 +5°C g

Y0000327 Azelastine impurity B 1 5 mg 1 1-benzoyl-2-[(4RS)-1-methylhexahydro-1H-azepin-4-yl]diazane 1633 +5°C g

Y0000328 Azelastine impurity D 1 5 mg 1 4-(4-chlorobenzyl)phthalazin-1(2H)-one 1633 +5°C g

Y0000329 Azelastine impurity E 1 5 mg 1 3-(4-chlorobenzilidene)isobenzofuran-1(3H)-one 1633 +5°C g

Y0000306 Azithromycin 3 200 mg 1 94.6% C–‡HŸœNœOŒœ 1649 Yes +5°C a

Y0000637 Azithromycin for peak identification 2 15 mg 1 1649 Yes +5°C a

Y0000641 Azithromycin for system suitability 5 0.05 mg 1 Batch 4 is valid until 30 June 2012 1649 Yes +5°C a

Y0000307 Azithromycin impurity A 2 10 mg 1 6-demethylazithromycin 1649 +5°C a

Y0000285 B19 virus DNA for NAT testing BRP 1 150 mg 5 B19 virus DNA content logŒÐ 5.8 IU per ml for plasma pool testing by NAT See leaflet,

0557,

1527,1646

Yes -20°C e(d)

B0070000 Bacampicillin hydrochloride 3 120 mg 1 92.9% CœŒHœ‡ClN–OŸS 0808,0852 +5°C a

B0100000 Bacitracin zinc 2 150 mg 1 62.9 IU per mg 0465,0466,20

702

-20°C b

B0200000 Baclofen 1 50 mg 1 0653 +5°C g

B0200050 Baclofen impurity A 3 50 mg 1 91.4% CŒÐHŒÐClNO; (¢£)-4-amino-3-(4-chlorophenyl)butyric acid lactam ; Batch 2 is valid until 31 January 2013

0653 Yes +5°C g

Y0001273 Baicalin 1 10 mg 1 88.5% CœŒHŒ‡OŒŒ 2438 Yes +5°C a

B0250000 Bambuterol hydrochloride 1 100 mg 1 1293 +5°C a

B0300000 Barbital - * psy 1 500 mg 1 0170 +5°C j

Y0001525 Basic butylated methacrylate copolymer 1 20 mg 1 1975 Yes +5°C a

Y0000295 Basic butylated methacrylate copolymer -reference spectrum 1 n/a 1 1975 l

B0305000 Beclometasone dipropionate anhydrous 4 150 mg 1 99.2% Cœ‡H–ŸClOŸ ; Batch 3 is valid until 1 June 2013 0654,1449,

1709

Yes +5°C a

Y0000351 Beclometasone dipropionate monohydrate 1 10 mg 1 1709 +5°C a

Y0000352 Beclometasone dipropionate for system suitability 3 15 mg 1 Batch 2 is valid until 28 February 2013 0654,1709 Yes +5°C a

Y0000469 Beclometasone dipropionate for peak identification 1 10 mg 1 0654,1709 Yes +5°C a

Y0001073 Beclometasone dipropionate impurities F and N 1 0.052 mg 1 0654,1709 Yes +5°C a

Y0001025 Benazepril hydrochloride 1 160 mg 1 99.5 % Cœ÷Hœ„ClNœO— 2388 +5°C a

Y0001038 Benazepril for system suitability 1 0.016 mg 1 2388 Yes +5°C a

Y0001026 Benazepril impurity A 1 10 mg 1 [(3R)-3-[[(1R)-1-(ethoxycarbonyl)-3-phenylpropyl]amino]-2-oxo-2,3,4,5- tetrahydro-1H-1-benzazepin-1-yl]acetic acid

2388 +5°C a

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B0400000 Bendroflumethiazide 1 100 mg 1 0370 +5°C a

Y0000564 Bendroflumethiazide impurity A 1 5 mg 1 4-amino-6-(trifluoromethyl)benzene-1,3-disulphonamide 0370 +5°C a

Y0000044 Benfluorex hydrochloride 1 50 mg 1 1601 +5°C a

Y0000043 Benfluorex hydrochloride for system suitability 1 360 mg 1 1601 +5°C a

B0470000 Benperidol 1 100 mg 1 1010,1172,12

54, 1708

+5°C a

B0477000 Benserazide hydrochloride 1 50 mg 1 1173 +5°C a

B0477010 Benserazide impurity A 1 20 mg 1 (¢£)-2-amino-3-hydroxypropanohydrazide 1173 +5°C a

Y0001071 Benserazide impurity C 1 10 mg 1 (2RS)-2-amino-3-hydroxy-2'-[(1EZ)-(2,3,4-trihydroxybenzylidene)]propanohydrazide

1173 +5°C a

Y0001079 Benserazide for peak identification 1 10 mg 1 1173 Yes +5°C a

Y0001064 Benzaldehyde 1 150 mg 1 0372,0371 Yes +5°C g

Y0001060 Benzalkonium chloride for system suitability 3 20 mg 1 0371,0372 Yes +5°C g

B0490000 Benzarone 1 10 mg 1 (2-ethylbenzofuran-3-yl)(4-hydroxyphenyl)methanone 1393 +5°C a

B0500000 Benzathine benzylpenicillin 2 200 mg 1 90.7% C÷‡H—ÿNÿO‡Sœ24.1% CŒÿHœÐNœ (N,N'-dibenzylethylenediamine)

0373 Yes +5°C a

Y0000775 Benzbromarone 1 10 mg 1 1393 +5°C g

B0550000 Benzethonium chloride 1 100 mg 1 0974 +5°C g

B0600000 Benzocaine 1 50 mg 1 0011,1088 +5°C a

Y0001470 Benzoic acid 1 30 mg 1 2424,2425,24

74

+5°C a

Y0000647 Benzophenone 1 40 mg 1 1784 +5°C g

Y0000167 Benzyl alcohol 2 50 mg 1 See leaflet 0256,0371,03

72,1827

Yes +5°C a

B0670000 Benzyl benzoate - reference spectrum 1 n/a 1 0705 l

B0680000 S-Benzylmercaptoacetyltriglycin 1 10 mg 1 1372 +5°C a

B0700000 Benzylpenicillin potassium 2 100 mg 1 0113,0148,01

49

+5°C a

B0900000 Benzylpenicillin sodium 7 200 mg 1 99.4% CŒÿHŒŸNœNaO÷S; Penicillin G sodium 0113,0114,01

48, 0149

Yes +5°C a

Y0001149 Berberine chloride 1 20 mg 1 84.3% CœÐHŒ‡ClNO÷ 1831,2500 Yes +5°C a

B0950000 Betadex 4 200 mg 1 88.4% [CÿHŒÐO—]Ÿ 1070,1487,18

04

+5°C a

Y0000391 Betahistine dihydrochloride 2 50 mg 1 Batch 1 is valid until 31 May 2012 1665 +5°C a

B0990000 Betahistine mesilate 1 100 mg 1 1071 +5°C a

B1000000 Betamethasone 4 75 mg 1 0312,0354,03

88, 0561,0811

+5°C g

B1030000 Betamethasone acetate 2 100 mg 1 0548,0975 +5°C g

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B1040000 Betamethasone dipropionate 3 150 mg 1 99.5% Cœ‡H–ŸFOŸ; Betamethasone dipropionate CRS 2 is suitable for monograph 01/008:0809 only.

0809 Yes +5°C g

Y0001416 Betamethasone dipropionate for peak identification 1 10 mg 1 0809 Yes +5°C g

Y0001418 Betamethasone dipropionate for system suitability 1 10 mg 1 0809 Yes +5°C g

B1045000 Betamethasone sodium phosphate 3 100 mg 1 0549,0810 +5°C g

B1054000 Betamethasone 17-valerate 3 100 mg 1 0322,0811 +5°C g

B1055000 Betamethasone 21-valerate 3 15 mg 1 0811 +5°C g

Y0001027 Betamethasone valerate for system suitability 1 25 mg 1 0811 Yes +5°C g

Y0001065 Betamethasone valerate impurity mixture 2 0.018 mg 1 Batch 1 is valid until 31 December 2012 0811 +5°C g

B1103000 Betaxolol hydrochloride 2 60 mg 1 Batch 1 is valid until 1 June 2013 1072 +5°C a

B1103100 Betaxolol impurity A 2 10 mg 1 (2RS)-1-(4-ethylphenoxy)-3-[(1-methylethyl)amino]propan-2-ol 1072 +5°C a

Y0001354 Betaxolol impurity C 1 5 mg 1 2-[[4-[2-(cyclopropylmethoxy)ethyl]phenoxy]methyl]oxirane 1072 -20°C c

Y0001360 Betaxolol for peak identification 1 15 mg 1 1072 Yes +5°C a

B1115000 Bezafibrate 1 100 mg 1 1394 +5°C a

Y0001444 Bicalutamide 1 100 mg 1 99.8% CŒ‡HŒ÷F÷NœO÷S 2196 Yes +5°C g

Y0001448 Bicalutamide for system suitability 1 15 mg 1 2196 Yes +5°C g

Y0001078 Bicisate labelling kit 1 24 mg 1 2123 +5°C g

B1110000 Bifonazole 1 100 mg 1 1395 +5°C a

B1110004 Bifonazole impurity B 3 10 mg 1 4-[(RS)-(biphenyl-4-yl)phenylmethyl]-1H-imidazole trifluoroacetate 1395 +5°C a

Y0001421 Bifonazole for system suitability 1 10 mg 1 1395 Yes +5°C a

Y0001059 Bilberry dry extract 1 250 mg 1 3.44% of cyanidin 3-O-glucoside chloride (CœŒHœŒClOŒŒ) 2394 Yes -20°C c

B1116000 Biotin 2 20 mg 1 Vitamin H 1073 +5°C a

B1120000 Biperiden hydrochloride 1 60 mg 1 1074 +5°C g

B1121000 Biperiden impurity A 2 20 mg 1 (1RS)-1-[(1SR,2SR,4SR)-bicyclo[2.2.1]hept-5-en-2-yl]-1-phenyl- 3- (piperidin-1-yl)propan-1-ol (endo form)

1074 +5°C g

B1140000 Bisacodyl 3 50 mg 1 0595 +5°C a

Y0000608 Bisacodyl for peak identification 1 10 mg 1 0595 +5°C a

Y0000694 Bisacodyl for system suitability 1 5 mg 1 0595 Yes +5°C a

Y0000812 Bisoprolol fumarate 1 50 mg 1 1710 +5°C a

Y0000877 Bisoprolol for peak identification 2 1.007 mg 1 Bisoprolol for system suitability method A CRS has been renamed asBisoprolol for peak identification CRS. ; Batch 1 is valid until 31 August 2012

1710 Yes +5°C a

Y0000813 Bisoprolol for system suitability 2 1.005 mg 1 Bisoprolol for system suitability method B CRS has been renamed asBisoprolol for system suitability CRS ; Batch 1 is valid until 30 April 2012

1710 Yes +5°C a

B1141000 Bleomycin sulfate 1 7 mg 1 8910 IU per vial; bleomycin Aœ : 67.0%; Bleomycin Bœ : 29.2%;demethylbleomycin Aœ : 2.6%

0976,20702 Yes -20°C a

Y0000434 Boldine 2 30 mg 1 98.8% CŒ„HœŒNO÷ 1396, 1816 Yes +5°C a

B1142000 Bordetella pertussis mouse antiserum BRP 1 0.5 mg 1 Anti-PT: 19.5 ELU/vial Anti-FHA: 69 ELU/vialAnti-69k: 17 ELU/vial Anti-Fim 2/3: 28 ELU/vial

See leaflet,

20716

Yes -20°C c

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B1143000 Bromazepam - * psy 3 60 mg 1 0778,0879 +5°C j

Y0000645 Bromazepam for system suitability - * psy 1 10 mg 1 0879 Yes +5°C j

B1145000 Bromhexine hydrochloride 3 100 mg 1 0706 +5°C g

Y0000200 Bromhexine impurity C 3 15 mg 1 N-(2-aminobenzyl)-N-methylcyclohexanamine ; Batch 2 is valid until 1 June2013

0706 +5°C a

B1150000 Bromocriptine mesilate 2 30 mg 1 0596 -20°C g(c)

Y0000677 Bromocriptine mesilate for system suitability 1 5 mg 1 0596 Yes -20°C g(c)

B1152000 Bromperidol 1 100 mg 1 0616,1178 +5°C a

B1152050 Bromperidol decanoate 1 60 mg 1 1397,1431 +5°C a

B1153000 Brompheniramine maleate 1 100 mg 1 0977,1196 +5°C a

Y0000468 Brotizolam - * psy 1 10 mg 1 2197 +5°C j

Y0000470 Brotizolam impurity B 1 10 mg 1 2-bromo-4-(2-chlorophenyl)-6H-thieno[3,2-f][1,2,4]triazolo[4,3-a][1,4]diazepine (demethylbrotizolam)

2197 +5°C a

B1155000 Brucella melitensis Rev. 1 strain BRP - * MOT (Biotox) 1 1 mg 1 0793 Yes +5°C e(b)

B1157300 Budesonide 4 110 mg 1 99.7% Cœ—H–÷Oÿ 1075 Yes +5°C a

Y0001148 Budesonide for system suitability 1 10 mg 1 1075 Yes +5°C a

B1156000 Bufexamac 1 100 mg 1 1179 +5°C a

B1157400 Buflomedil hydrochloride 2 100 mg 1 1398 +5°C a

Y0001529 Buflomedil for peak identification 1 0.45 mg 1 1398 Yes +5°C a

B1157410 Buflomedil impurity B 2 20 mg 1 4-(pyrrolidin-1-yl)-1-(4-hydroxy-2,6-dimethoxyphenyl)butan-1-one 1398 +5°C a

B1158000 Bumetanide 1 150 mg 1 1076 +5°C a

Y0000309 Bumetanide impurity A 1 5 mg 1 3-nitro-4-phenoxy-5-sulphamoylbenzoic acid 1076 +5°C a

Y0000310 Bumetanide impurity B 1 5 mg 1 3-amino-4-phenoxy-5-sulphamoylbenzoic acid 1076 +5°C a

B1160000 Bupivacaine hydrochloride 2 100 mg 1 0541 +5°C g

Y0000088 Bupivacaine impurity B 2 20 mg 1 (2RS)-N-(2,6-dimethylphenyl)piperidine-2-carboxamide 0541 +5°C a

Y0000089 Bupivacaine impurity E 2 20 mg 1 6-(butylamino)-N-(2,6-dimethylphenyl)hexanamide 0541 +5°C g

Y0001108 Buprenorphine - * psy 1 10 mg 1 1180 +5°C j

Y0001109 Buprenorphine hydrochloride - * psy 1 10 mg 1 1181 +5°C j

Y0001122 Buprenorphine for system suitability - * psy 1 10 mg 1 1180,1181 Yes +5°C j

B1168000 Buserelin 2 2 mg 1 2.00 mg per vial of CÿÐH‡ÿNŒÿOŒ– 1077 -20°C c

B1168020 D-His-Buserelin 1 0.5 mg 1 1077 -20°C c

Y0000131 Buspirone hydrochloride 1 5 mg 1 1711 +5°C g

Y0000471 Buspirone for system suitability 1 2 mg 1 1711 Yes +5°C g

B1170000 Busulfan 1 50 mg 1 0542 +5°C g

Y0001487 Butyl methacrylate 1 100 mg 1 1975 +5°C g

Y0001304 Butyl methanesulfonate 1 30 µL 1 20537,20538,

20539

Yes +5°C a

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B1217000 Butyl parahydroxybenzoate 2 100 mg 1 See leaflet 0881,1216 Yes +5°C a

Y0001357 Butyl parahydroxybenzoate impurity E 1 15 mg 1 2-methylpropyl 4-hydroxybenzoate (iso-butyl parahydroxybenzoate) 0881 +5°C a

New B1212000 Butylhydroxyanisole 4 60 mg 1 Batch 3 is valid until 31 August 2013 0880 +5°C g

B1215000 Butylhydroxytoluene 1 50 mg 1 Plastic additive 07 0581,30103,

30105,30106,

30107

+5°C g

Y0000472 Cabergoline 1 100 mg 1 99.8% CœÿH–ŸN—Oœ 1773 Yes -20°C c

C0100000 Caffeine 4 70 mg 1 See leaflet 0267,0268,15

04

Yes +5°C g

Y0000787 Caffeine for system suitability 2 20 mg 1 0267, 0268 Yes +5°C g

C0166000 Calcifediol 4 5 mg 1 95.3% CœŸH÷÷Oœ ; Batch 3 is valid until 28 February 2013 1295 Yes -20°C e(d)

C0166001 Calcifediol - reference spectrum 1 n/a 1 1295 l

Y0000499 Calcipotriol (anhydrous) - reference spectrum 1 n/a 1 2011 l

New Y0000473 Calcipotriol monohydrate 2 10 mg 1 94.3% CœŸH÷ÐO– ; Batch 1 is valid until 31 August 2013 2011,2284 Yes +5°C g

Y0000474 Calcipotriol monohydrate - reference spectrum 1 n/a 1 2284 l

C0200000 Calcitonin (salmon) 9 1 mg 2 0.95 mg per vial CŒ÷—Hœ÷ÐN÷÷O÷‡Sœ ; Batch 8 is valid until 1 June 2013 0471 Yes -20°C c

Y0000632 Calcitonin-Gly 2 1 ml 1 About 0.9 mg per ml 0471 -20°C c

C0200010 N-acetyl-cys1-calcitonin 4 0.1 mg 1 about 0.1mg N-acetyl-cys-1-calcitonin per vial 0471 -20°C c

C0225000 Calcitriol 8 10 mg 1 99.8% CœŸH÷÷O– ; Batch 7 is valid until 31 July 2012 0883 Yes -20°C e(d)

C0226000 Calcitriol - reference spectrum 1 n/a 1 0883 l

C0249000 Calcium ascorbate - reference spectrum 1 n/a 1 1182 l

C0250000 Calcium folinate 5 100 mg 1 85.5 % CœÐHœŒCaNŸOŸ 0978,1606 +5°C a

C0299000 Calcium glucoheptonate 1 60 mg 1 1399 +5°C a

C0300000 Calcium gluconate 1 100 mg 1 Calcium digluconate 0172,0658,09

79,1399,2161

,2162,2164,2

+5°C a

C0340000 Calcium levulinate dihydrate 1 250 mg 1 1296 +5°C a

C0350000 Calcium oxalate monohydrate 1 500 mg 1 Loss of 12.1% m/m (U= 0.2%, n=10, k=2.23) 20234 Yes +5°C a

C0400000 Calcium pantothenate 3 60 mg 1 0470 +5°C a

C0405000 Camphor (racemic) 1 50 mg 1 0655,1600 +5°C g

Y0001388 Candesartan cilexetil 1 60 mg 1 2375 +5°C a

Y0001387 Candesartan cilexetil for peak identification 1 10 mg 1 2375 Yes +5°C a

Y0001389 Candesartan cilexetil for system suitability 1 10 mg 1 2573 Yes +5°C a

C0410000 Canrenone 3 50 mg 1 0688 +5°C g

C0426000 Caprylic acid 1 200 mg 1 1401,1471 +5°C g

Y0000671 Capsaicin 2 50 mg 1 98,7% CŒ‡HœŸNO– ; (E)-N-[(4-Hydroxy-3-methoxyphenyl)methyl]-8- methylnon-6-enamide ; Batch 1 is valid until 1 April 2013

1859,2336,23

37

Yes +5°C g

C0430000 Captopril 2 10 mg 1 1079 +5°C a

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New Y0001182 Captopril for system suitability 2 20 mg 1 Batch 1 is valid until 31 August 2013 1079 +5°C a

Y0001219 Captopril impurity B 1 10 mg 1 87.4% C„HŒ÷BrNO–; (2S)1-[(2S)-3-bromo-2-methylpropanoyl]pyrrolidine-2- carboxylic acid

1079 +5°C a

Y0001220 Captopril impurity C 1 10 mg 1 84.8% C÷H‡OœS; (2RS)-2-methyl-3-sulphanylpropanoic acid 1079 +5°C a

Y0001221 Captopril impurity D 1 10 mg 1 85.4% C÷HŸBrOœ; (2RS)-3-bromo-2-methylpropanoic acid 1079 +5°C a

Y0000435 Captopril impurity E 1 10 mg 1 (2S)-1-isobutyryl-pyrrolidine-2-carboxylic acid 1079 +5°C a

Y0001450 Captopril impurity J 1 10 mg 1 92.5% CŒŒHŒŸNO÷S; (2S)-1-[(2S)-3-(acetylsulfanyl)-2-methylpropanoyl]pyrrolidine-2-carboxylic acid (acetylcaptopril)

1079 Yes +5°C a

Y0000113 Carbachol 1 50 mg 1 1971 +5°C g

C0450000 Carbamazepine 4 200 mg 1 100.0% CŒ—HŒœNœO 0543 +5°C a

Y0000033 Carbamazepine impurity A 5 10 mg 1 10,11-dihydro-5H-dibenz[b,f]azepine-5-carboxamide (10,11- dihydrocarbamazepine)

0543 +5°C a

C0451000 Carbasalate calcium - reference spectrum 1 n/a 1 1185 l

Y0001161 Carbasalate impurity B 1 5 mg 1 1185 +5°C a

C0455000 Carbenicillin sodium 2 50 mg 1 0956 +5°C a

C0460000 Carbidopa 2 50 mg 1 0755 +5°C a

C0465000 Carbimazole 2 120 mg 1 99.7% CŸHŒÐNœOœS ; Batch 1 is valid until 30 June 2012 0884 Yes +5°C a

C0470000 Carbocisteine 2 60 mg 1 0885 +5°C a

C0499900 Carbon dioxide - reference spectrum 1 n/a 1 0375 l

C0550000 Carboplatin - reference spectrum 1 n/a 1 1081 l

Y0000475 Carboprost trometamol 1 40 mg 1 99.1% Cœ—H÷ŸNO‡ 1712 -20°C c

Y0000536 Carboprost trometamol - reference spectrum 1 n/a 1 1712 l

Y0000035 Carisoprodol 1 50 mg 1 1689 +5°C a

Y0000036 Carisoprodol impurity A 1 10 mg 1 (2RS)-2-(hydroxymethyl)-2-methylpentyl(1-methylethyl)- carbamate 1689 +5°C a

Y0001214 Carmellose 1 10 mg 1 2360 +5°C a

C0580004 Carmustine - reference spectrum 1 n/a 1 1187 l

C0580010 Carmustine impurity A 1 20 mg 1 1,3-bis(2-chloroethyl)urea 1187 -20°C g(c)

Y0000846 Carprofen for veterinary use 1 30 mg 1 2201 +5°C g

Y0000884 Carprofen for system suitability 1 5 mg 1 2201 +5°C g

Y0000192 Carteolol hydrochloride - reference spectrum 1 n/a 1 1972 l

Y0000193 Carteolol for system suitability 1 30 mg 1 1972 Yes +5°C a

Y0001427 Carvedilol 1 50 mg 1 1745 +5°C g

Y0000075 Carvedilol - reference spectrum 1 n/a 1 1745 l

Y0000103 Carvedilol impurity C 2 10 mg 1 (2RS)-1-[benzyl[2-(2-methoxyphenoxy)ethyl]amino]-3-(9H- carbazol-4-yloxy)propan-2-ol

1745 +5°C g

Y0001426 Carvedilol for system suitability 1 10 mg 1 1745 Yes +5°C g

C0600000 Casein BRP 3 100000 mg 1 Batch 2 is valid until 31 December 2012 0350 +5°C a

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C0630000 Cefaclor 2 450 mg 1 95.0% CŒ—HŒ÷ClN–O÷S 0986 +5°C a

C0640000 Delta-3-Cefaclor 3 20 mg 1 0986 -20°C c

New C0650000 Cefadroxil 3 250 mg 1 93,8% CŒÿHŒŸN–O—S ; Batch 2 is valid until 1 July 2013 0260,0577,08

13,2342

Yes +5°C a

C0675000 Cefalexin monohydrate 3 150 mg 1 94.2% CŒÿHŒŸN–O÷S 0708,0814 Yes +5°C a

C0682000 Cefalotin sodium 2 100 mg 1 98.8% CŒÿHŒ—NœNaOÿSœ 0987 +5°C a

Y0000505 Cefalotin for impurity B identification 1 10 mg 1 0987 +5°C a

C0682300 Cefamandole nafate 3 125 mg 1 99.0% CŒ„HŒŸNÿNaOÿSœ 1402 +5°C a

Y0000240 Cefapirin sodium 1 100 mg 1 98.5% CŒŸHŒÿN–NaOÿSœ 1650 Yes +5°C a

C0682400 Cefatrizine propylene glycol 1 150 mg 1 81.8% CŒ‡HŒ‡NÿO—Sœ 1403 +5°C a

C0682410 Cefatrizine impurity A 1 60 mg 1 7-amino-(6R,7R)-3-[(2H-1,2,3-triazol-4-yl)sulfanyl]-methyl-8- oxo-5-thia-1- azabicyclo[4.2.0]oct-2-ene-2-carboxylic acid (7-ACA triazole)

1403 +5°C a

C0682800 Cefazolin 3 150 mg 1 99.6% CŒ÷HŒ÷N‡O÷S– 0988 Yes +5°C a

Y0000633 Cefepime dihydrochloride monohydrate 1 150 mg 1 95.2% CŒ„HœÿClœNÿO—Sœ 2126 +5°C g

Y0000634 Cefepime dihydrochloride monohydrate for system suitability 1 15 mg 1 2126 Yes +5°C g

Y0001336 Cefepime impurity E 1 10 mg 1 (6R,7R)-7-amino-3-[(1-methylpyrrolidinio)methyl]-8-oxo-5- thia-1-azabicyclo[4.2.0]oct-2-ene-2-carboxylate

2126 -20°C g(c)

C0684000 Cefixime 3 200 mg 1 88.8% CŒÿHŒ—N—OŸSœ 1188 -20°C c

C0684750 Cefoperazone dihydrate 2 100 mg 1 94.2% Cœ—HœŸN„O‡Sœ 1404 Yes +5°C a

C0684800 Cefoperazone sodium - reference spectrum 1 n/a 1 1404 l

Y0000420 Cefotaxime acid 1 80 mg 1 94.3% CŒÿHŒŸN—OŸSœ 0989 +5°C a

C0685000 Cefotaxime sodium 4 30 mg 1 0708,0989 +5°C a

Y0000506 Cefotaxime for peak identification 1 10 mg 1 0989 Yes +5°C a

C0688000 Cefoxitin sodium 3 100 mg 1 97.4% CŒÿHŒÿN–NaOŸSœ 0990 +5°C g

Y0001496 Cefoxitin sodium for peak identification 1 15 mg 1 0990 Yes +5°C g

Y0001305 Cefpodoxime proxetil 1 70 mg 1 97.1% CœŒHœŸN—O„Sœ 2341 Yes -20°C b

Y0001318 Cefpodoxime proxetil for impurity H identification 1 10 mg 1 2341 Yes -20°C b

Y0001306 Cefpodoxime proxetil for peak identification 1 10 mg 1 2341 Yes -20°C b

Y0001371 Cefprozil 1 120 mg 1 2342 Yes +5°C a

Y0001368 Cefprozil impurity mixture 1 10 mg 1 2342 Yes +5°C a

Y0001372 Cefprozil impurity A 1 20 mg 1 (2R)-2-amino-2-(4-hydroxyphenyl)acetic acid(p-hydroxyphenylglycine)

2342 +5°C a

Y0001367 Cefprozil for peak identification 1 10 mg 1 2342 Yes +5°C a

C0690000 Cefradine 4 300 mg 1 93.9% 0167,0168,05

78,

Yes +5°C a

Y0000568 Cefradine for peak identification 2 15 mg 1 Must be used with Cefradine impurity mixture CRS Y0001174 0814 Yes +5°C a

Y0001174 Cefradine impurity mixture 1 0.04 mg 1 Must be used with Cefradine for peak identification Y0000568 0814 Yes +5°C a

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C0690500 Ceftazidime 2 200 mg 1 85.3% CœœHœœNÿOŸSœ 1405 +5°C g

Y0001111 Ceftazidime for peak identification 1 10 mg 1 1405, 2344 Yes +5°C g

C0691000 Ceftriaxone sodium 3 100 mg 1 90.4% CŒ‡HŒÿN‡NaœOŸS– 0991 Yes +5°C a

C0692000 Ceftriaxone impurity A 4 10 mg 1 E-isomer 0991 +5°C a

New C0694990 Cefuroxime axetil 4 60 mg 1 97.4% CœÐHœœN÷OŒÐS 1300 +5°C a

C0695000 Cefuroxime sodium 3 150 mg 1 96.7% CŒÿHŒ—N÷NaO‡S 0988,0992 Yes +5°C a

Y0001445 Celecoxib 1 200 mg 1 99.9% CŒŸHŒ÷F–N–OœS 2591 Yes +5°C a

Y0001446 Celecoxib impurity A 1 10 mg 1 4-[5-(3-methylphenyl)-3-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide

2591 +5°C a

Y0001447 Celecoxib impurity B 1 10 mg 1 4-[3-(4-methylphenyl)-5-(trifluoromethyl)-1H-pyrazol-1-yl]benzenesulfonamide

2591 +5°C a

Y0000311 Celiprolol hydrochloride 1 10 mg 1 1632 +5°C a

Y0000312 Celiprolol impurity I 1 0.02 mg 1 1-acetyl-1-(4-ethoxyphenyl)-3,3-diethylurea 1632 +5°C a

Y0000239 Celiprolol for peak identification 2 20 mg 1 Batch 1 is valid until 30 June 2012 1632 Yes +5°C a

Y0000784 Cellulose acetate 1 40 mg 1 0887 +5°C a

C0698005 Cellulose acetate butyrate - reference spectrum 1 n/a 1 1406 l

Y0001054 Cellulose acetate phthalate 1 10 mg 1 0314 +5°C a

C0700000 Cephaëline hydrochloride 3 15 mg 1 0080,0081,00

93,

0094,1530,18

75

+5°C g

C0980650 Cetirizine dihydrochloride 4 100 mg 1 1084 +5°C g

New C0980651 Cetirizine impurity A 5 10 mg 1 (RS)-1-[(4-chlorophenyl)phenylmethyl]piperazine ; Batch 4 is valid until 31July 2013

1084 +5°C g

Y0001197 Cetirizine for peak identification 1 1.01 mg 1 Replaces Cetirizine impurity mixture CRS 1084 Yes +5°C g

C0984100 Cetostearyl isononanoate - reference spectrum 1 n/a 1 1085 l

C0990000 Cetyl alcohol 1 250 mg 1 100% CŒÿH–÷O 0540,0702,08

01,

0802,0847,09

69, 1411

Yes +5°C a

Y0000073 Cetyl palmitate 15 1 60 mg 1 1906 +5°C a

Y0000074 Cetyl palmitate 95 1 50 mg 1 1906 +5°C a

C1000000 Cetylpyridinium chloride 2 20 mg 1 Batch 1 is valid until 30 April 2012 0379 +5°C g

New C1050000 Chenodeoxycholic acid 3 125 mg 1 Batch 2 is valid until 31 August 2013 1189,1275 +5°C a

Y0000104 Chitosan hydrochloride 1 30 mg 1 1774 +5°C a

C1100000 Chlorambucil 1 100 mg 1 0137 +5°C g

Y0001298 Chlorambucil for system suitability 1 10 mg 1 0137 Yes +5°C g

Y0001299 Chlorambucil with impurity G 1 10 mg 1 0137 +5°C g

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C1200000 Chloramphenicol 3 500 mg 1 0071,0473,07

09

+5°C g

C1300000 Chloramphenicol dipalmitate 1 100 mg 1 0473 +5°C g

C1350000 Chloramphenicol disodium disuccinate 3 25 mg 1 91.1% CŒ„HŒ‡ClœNœNaœOŒŒ 0709 +5°C g

C1400000 Chloramphenicol palmitate isomer 1 100 mg 1 0473 +5°C g

C1425000 Chloramphenicol sodium succinate 1 1500 mg 1 0709 +5°C g

C1435000 Chlorcyclizine hydrochloride 1 100 mg 1 1086 +5°C a

C1450000 Chlordiazepoxide - * psy 1 50 mg 2 0656,1974 +5°C j

C1500000 Chlordiazepoxide hydrochloride - * psy 1 100 mg 1 0474 +5°C j

Y0000476 Chlordiazepoxide impurity A 1 10 mg 1 7-chloro-5-phenyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one 4-oxide 0474,0656 +5°C a

C1510000 Chlorhexidine 4 50 mg 1 0658 +5°C g

C1520000 Chlorhexidine diacetate 2 10 mg 1 0657 +5°C g

C1540000 Chlorhexidine dihydrochloride 2 50 mg 1 0659 +5°C g

Y0001545 Chlorhexidine for system suitability 1 5 mg 1 0658 Yes +5°C a

C1530000 Chlorhexidine for performance test 5 50 mg 1 0657,0658,06

59

Yes +5°C g

Y0000569 Chlorogenic acid 1 20 mg 1 96.9% CŒÿHŒ‡O„ ; (1S,3R,4R,5R)-3-[(3,4-Dihydroxycinnamoyl)oxy]-1,4,5- trihydroxycyclohexanecarboxylic acid

1821,1822,18

23,

1824,1866,18

97, 2389

+5°C a

C2223030 1-(4-Chlorophenyl)-1-phenylethanol 3 15 mg 1 Clemastine fumarate impurity C 1190 -20°C g(c)

C1650000 Chloroquine sulfate 3 200 mg 1 0544,0545 +5°C g

C1700000 Chlorothiazide 2 100 mg 1 0385,0394 +5°C a

C1800000 Chlorphenamine maleate 1 100 mg 1 0386,0977,10

84, 1196

+5°C g

Y0000436 Chlorphenamine impurity A 3 0.01 mg 1 2-(4-chlorophenyl)-4-(dimethylamino)-2-[2-(dimethylamino)ethyl]butanenitrile

0386 +5°C g

Y0000437 Chlorphenamine impurity C 1 10 mg 1 (3RS)-3-(4-chlorophenyl)-N-methyl-3-(pyridin-2-yl)propan-1- amine 0386 +5°C g

C1900000 Chlorpromazine hydrochloride 1 200 mg 1 0475,20303 +5°C f

Y0000507 Chlorpromazine impurity A 1 15 mg 1 3-(2-chloro-10H-phenothiazin-10-yl)-N,N-dimethylpropan-1- amine S-oxide (chlorpromazine sulphoxide)

0475 +5°C f

Y0000479 Chlorpromazine impurity D 1 10 mg 1 3-(2-chloro-10H-phenothiazin-10-yl)-N-methypropan-1-amine(demethylchlorpromazine)

0475 +5°C f

Y0000508 Chlorpromazine impurity E 1 10 mg 1 2-chloro-10H-phenothiazine 0475 +5°C g

Y0001449 Chlorpromazine impurity F 1 2 mg 1 3-(4-chloro-10H-phenothiazin-10-yl)-N,N-dimethylpropan-1-amine 0475 +5°C f

C1905000 Chlorpropamide 1 100 mg 1 1087 +5°C a

C1905020 Chlorpropamide impurity B 1 50 mg 1 1,3-Dipropylurea 1087 +5°C a

C1915000 Chlorprothixene hydrochloride 4 50 mg 1 2.0% E-isomer 0815,1365 +5°C g

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New C1950000 Chlortalidone 3 150 mg 1 99.7% CŒ÷HŒŒClNœO÷S ; Batch 2 is valid until 31 August 2013 0546 Yes +5°C a

Y0000779 Chlortalidone for peak identification 2 1.017 mg 1 0546 Yes +5°C a

C2000000 Chlortetracycline hydrochloride 5 100 mg 1 92.4% of of C22H24Cl2N2O8 ; Batch 4 is valid until 31 December 2012 0173 Yes +5°C a

Y0001451 Chlortetracycline for system suitability 1 20 mg 1 0173 Yes +5°C a

C2100000 Cholecalciferol 8 500 mg 1 100% CœŸH÷÷O ; Vitamin D3 ; Batch 7 is valid until 30 June 2012 0072,0574,05

75,

0598,1192,11

93

Yes -20°C g(c)

C2150000 Cholecalciferol for system suitability 6 1 mL 1 0072,0082,05

74,

-20°C g(c)

C2155000 Cholesterol 3 100 mg 1 99.5% CœŸH÷ÿO 0993,0593 Yes +5°C a

C2158000 Cholic acid 2 60 mg 1 1189 +5°C a

Y0000280 Chondroitin sulfate sodium 2 250 mg 1 99.6 % HœO(CŒ÷HŒ„NNaœOŒ÷S)¨ ; Batch 1 is valid until 1 May 2013 2064,2090 Yes +5°C a

Y0000593 Chondroitin sulfate sodium (marine) 1 100 mg 1 2064 +5°C a

C2160000 Chymotrypsin BRP 2 100 mg 1 6.01 microkatals per mg 0476,0694 Yes +5°C a

Y0001553 Ciclesonide 1 150 mg 1 99.8 % C–œH÷÷OŸ 2703 Yes +5°C a

Y0001554 Ciclesonide containing impurity A 1 15 mg 1 (2ʹS)-2ʹ-cyclohexyl-11b-hydroxy-3,20-dioxo-16bH-[1,3]dioxolo[4ʹ,5ʹ:16,17]pregna-1,4-diene-21-yl 2-methylpropanoate (S-epimer of ciclesonide)

2703 +5°C a

Y0001555 Ciclesonide impurity B 1 10 mg 1 (2ʹR)-2ʹ-cyclohexyl-11b,21-dihydroxy-16bH-[1,3]dioxolo[4ʹ,5ʹ:16,17]pregna-1,4-diene-3,20-dione

2703 +5°C a

Y0001556 Ciclesonide impurity C 1 10 mg 1 (2ʹR)-2ʹ-[(1RS)-cyclohex-3-enyl]-11b-hydroxy-3,20-dioxo-16bH-[1,3]dioxolo[4ʹ,5ʹ:16,17]pregna-1,4-diene-21-yl 2-methylpropanoate

2703 +5°C a

Y0000040 Ciclopirox 1 100 mg 1 1407 +5°C g

C2162701 Ciclopirox impurity A 3 40 mg 1 (¢£)-2-(3-cyclohexyl-5-methyl-4,5-dihydroisoxazol-5-yl)acetic acid 1302,1407 +5°C g

C2162702 Ciclopirox impurity B 3 20 mg 1 6-cyclohexyl-4-methyl-2H-pyran-2-one 1302,1407 -20°C c

C2162700 Ciclopirox olamine 2 150 mg 1 Batch 1 is valid until 31 May 2012 1302 +5°C g

C2163000 Ciclosporin 3 120 mg 1 98.5% CÿœHŒŒŒNŒŒOŒœ 0994 +5°C a

Y0000361 Ciclosporin for system suitability 1 5 mg 1 0994 +5°C a

C2170000 Cilastatin sodium 2 10 mg 1 1408 +5°C a

C2174000 Cilazapril 1 50 mg 1 1499 +5°C a

C2174002 Cilazapril impurity A 1 25 mg 1 1,1-dimethylethyl(1S,9S)-9-[[(S)-1-ethoxycarbonyl-3-phenylpropyl]amino]-10-oxo-octahydro-6H-pyridazino[1,2a][1,2]diazepine-1-caboxylate

1499 +5°C a

C2174005 Cilazapril impurity D 1 10 mg 1 (1S,9S)-9-[[(R)-1-ethoxycarbonyl-3-phenylpropyl]amino]-10- oxo- octahydro-6H-pyridazino[1,2a][1,2]diazepine-1-carboxylic acid

1499 +5°C a

C2175000 Cimetidine 1 50 mg 1 0756 +5°C a

C2175500 Cimetidine hydrochloride 1 100 mg 1 1500 +5°C a

Y0001130 Cimetidine for peak identification 1 10 mg 1 0756 Yes +5°C a

Y0001146 Cimetidine for system suitability 1 0.5085 mg 1 756 Yes +5°C a

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C2177000 Cinchocaine hydrochloride 1 60 mg 1 1088 +5°C g

Y0000176 Cineole 2 180 mg 1 1973 +5°C g

C2180000 Cinnarizine 2 100 mg 1 0816 +5°C a

Y0000362 Ciprofibrate 1 5 mg 1 2013 +5°C a

Y0000363 Ciprofibrate for system suitability 1 5 mg 1 2013 Yes +5°C a

Y0000198 Ciprofloxacin 1 20 mg 1 1089 +5°C g

C2190000 Ciprofloxacin hydrochloride 4 100 mg 1 93.6% CŒŸHŒ„ClFN–O– 0888,1353 +5°C g

New Y0000199 Ciprofloxacin hydrochloride for peak identification 2 15 mg 1 Batch 1 is valid until 31 August 2013 0888,1089 Yes +5°C g

C2190050 Ciprofloxacin impurity A 4 10 mg 1 7-chloro-1-cyclopropyl-6-fluoro-1,4-dihydro-4-oxo-quinoline-3-carboxylic acid (fluoroquinolonic acid)

0888,1089,22

29

+5°C a

C2210000 Cisplatin 5 100 mg 1 99.7% [PtClœ(NH–)œ] 0599 Yes +5°C g

Y0001018 Cisplatin impurity A 1 15 mg 1 trans-diamminedichloroplatinum (II) 0599 +5°C a

Y0001019 Cisplatin impurity B 1 15 mg 1 94.1% [PtCl–(NH–)]-; amminetrichloroplatinate(-) 0599 Yes +5°C g

Y0001008 Citalopram hydrobromide 1 5 mg 1 2288 +5°C g

Y0001007 Citalopram hydrochloride 1 5 mg 1 2203 +5°C g

Y0000855 Citalopram for system suitability 3 0.065 mg 1 Batch 2 is valid until 30 September 2012 2203,2288 Yes +5°C g

A1202000 Citric acid (anhydrous) 2 50 mg 1 0455 +5°C g

C2219000 Citric acid monohydrate 1 50 mg 1 0456 +5°C g

Y0000639 Cladribine 1 50 mg 1 99.1% CŒÐHŒœClN—O– 2174 +5°C g(b)

Y0000609 Cladribine for peak identification 1 10 mg 1 2174 Yes +5°C g(b)

Y0000610 Cladribine impurity C 1 5 mg 1 2-chloro-7H-purin-6-amine 2174 +5°C g(b)

Y0000320 Clarithromycin 3 160 mg 1 97.7% C–‡Hÿ„NOŒ– 1651 Yes +5°C a

Y0000321 Clarithromycin for peak identification 2 40 mg 1 Batch 1 is valid until 31 October 2012 1651 Yes +5°C a

Y0000269 Clazuril for system suitability 1 10 mg 1 1714 Yes +5°C a

Y0001193 Clazuril 1 10 mg 1 1714 +5°C a

C2221000 Clebopride malate 1 100 mg 1 1303 +5°C a

C2223000 Clemastine fumarate 1 100 mg 1 1190 +5°C g

C2248000 Clenbuterol hydrochloride 2 30 mg 1 1409 +5°C g

C2248010 Clenbuterol impurity B 2 10 mg 1 1-(4-amino-3,5-dichlorophenyl)-2-[(1,1-dimethylethyl)amino] ethanone 1409 +5°C g

C2250000 Clindamycin hydrochloride 4 200 mg 1 94.4% CŒ‡H–÷ClœNœO—S 0582,0583,09

96

+5°C a

C2269000 Clindamycin phosphate 2 250 mg 1 95.7% CŒ‡H–÷ClNœO‡PS 0996 +5°C a

Y0000364 Clioquinol 1 5 mg 1 2111 +5°C g

Y0000205 Clobazam - reference spectrum 1 n/a 1 1974 l

Y0000241 Clobazam impurity A 1 10 mg 1 7-chloro-5-phenyl-1,5-dihydro-1,5-dihydro-3H-1,5-benzodiazepine-2,4-dione 1974 +5°C a

Y0000559 Clobetasol propionate 1 40 mg 1 99.6% Cœ—H–œClFO— 2127 +5°C a

Y0000570 Clobetasol for peak identification 1 2 mg 1 2127 Yes +5°C a

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Y0000571 Clobetasol impurity J 1 0.4 mg 1 (17R)-4'-chloro-5'-ethyl-9-fluoro-11ß-hydroxy-16ß-methylspiro[androsta-1,4-diene-17,2'(3'H)-furan]-3,3'-dione (17 alpha-spiro compound)

2127 +5°C a

C2285000 Clobetasone butyrate 1 50 mg 1 1090 +5°C a

Y0001137 Clobetasone butyrate for system suitability 1 30 mg 1 1090 Yes +5°C a

Y0000888 Clodronate disodium tetrahydrate 1 5 mg 1 1777 +5°C g

Y0000885 Clodronate impurity D 1 5 mg 1 (chloromethylene)bis(phosphonic acid) 1777 +5°C g

Y0000313 Clofazimine 1 150 mg 1 2054 +5°C a

Y0000358 Clofazimine for system suitability 1 10 mg 1 2054 Yes +5°C a

C2300000 Clofibrate 1 0.5 ml 1 0318 +5°C g

C2320000 Clomifene citrate 2 50 mg 1 44% of Z-isomer C–œH–ÿClNO‡ 0997,1046 +5°C a

C2332000 Clomifene citrate for performance test 1 50 mg 1 0997 Yes +5°C a

C2360000 Clomipramine hydrochloride 1 100 mg 1 0889 +5°C a

Y0000132 Clomipramine impurity C 1 10 mg 1 94.5% CŒ„HœŒClNœ; 3-(3-chloro-5H-dibenzo[b,f]azepin-5-yl)-N,N- dimethylpropan-1-amine

0889 Yes +5°C a

Y0000133 Clomipramine impurity D 2 10 mg 1 3-(3,7-dichloro-10,11-dihydro-5H-dibenzo[b,f]azepin-5-yl)-N,N- dimethylpropan-1-amine ; Batch 1 is valid until 31 December 2012

0889 Yes +5°C a

Y0000134 Clomipramine impurity F 1 5 mg 1 3-chloro-10,11-dihydro-5H-dibenzo[b,f]azepine 0889 +5°C a

C2385000 Clonazepam - * psy 1 50 mg 1 1974,0415 +5°C j

Y0000286 Clonazepam - reference spectrum 1 n/a 1 0890 l

C2385015 Clonazepam impurity B 2 5 mg 1 3-Amino-4-(2-chlorophenyl)-6-nitro-1§-quinolin-2-one 0890 +5°C a

C2400000 Clonidine hydrochloride 1 100 mg 1 0477 +5°C f

Y0000801 Clonidine impurity B 1 20 mg 1 1-acetyl-2-[(2,6-dichlorophenyl)amino]-4,5-dihydro-1H-imidazole 0477 +5°C a

Y0000833 Clopamide 1 40 mg 1 1747 +5°C a

Y0000848 Clopamide for system suitability 1 10 mg 1 1747 Yes +5°C a

Y0001333 Clopidogrel hydrogen sulfate 1 60 mg 1 2531 +5°C g

Y0001335 Clopidogrel impurity A 1 10 mg 1 (2S)-(2-chlorophenyl)[6,7-dihydrothieno[3,2-c]pyridin-5(4H)-yl]acetic acid 2531 +5°C g

Y0001334 Clopidogrel for system suitability 1 100 mg 1 2531 Yes +5°C g

Y0000392 Closantel sodium dihydrate 1 20 mg 1 1716 +5°C g

Y0000393 Closantel for system suitability 1 20 mg 1 1716 Yes +5°C g

C2424400 Clostridia (multi-component) rabbit antiserum(for vaccines-

vet.use)BRP

1 1 mg 1 see information on the accompanying leaflet 0362,0363,03

64, 0697

Yes -20°C c

C2424550 Clostridium tetani guinea pig antiserum (for vaccines - human use)

BRP

1 1 mg 3 0.20 IU per vial (determined using toxin neutralisation test) 20708 Yes -20°C c

C2424500 Clostridium tetani guinea pig antiserum (for vaccines - vet. use)

BRP

1 1 mg 1 34 IU per vial See leaflet,

0697

Yes -20°C c

C2425600 Clostridium tetani rabbit antiserum (for vaccines - vet. use) BRP 1 1 mg 1 15 IU per vial See leaflet,

0697

Yes -20°C c

C2430000 Clotrimazole 3 100 mg 1 0757 +5°C g

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Y0000818 Clotrimazole impurity E 2 15 mg 1 0757 +5°C g

Y0000849 Clotrimazole for peak identification 2 1.005 mg 1 Batch 1 is valid until 31 October 2012 0757 Yes +5°C g

C2450000 Cloxacillin sodium 4 200 mg 1 93.9% CŒ„HŒŸClN–NaO—S 0661,0663,06

68, 2260

+5°C a

C2460000 Clozapine 2 60 mg 1 1191 +5°C g

Y0000758 Clozapine for peak identification 1 0.41 mg 1 1191 Yes +5°C g

Y0001472 Coagulation Factors V, VIII, XI and XIII plasma 1 1 mg 2 Factor V : 0.73 IU per vial, Factor VIII : 0.74 IU per vial, Factor XI : 0.59 IU per vial, Factor XIII : 0.79 IU per vial

0903,1646,20

740,20722

Yes -20°C d

Y0000162 Cocaine hydrochloride - reference spectrum 1 n/a 1 0073 l

C2480000 Cocoyl caprylocaprate 1 40 mg 1 1411 +5°C a

Y0000722 Codeine - * narc 1 20 mg 1 See leaflet 0076,1839,18

41

Yes +5°C k

C2500000 Codeine - reference spectrum 1 n/a 1 0074,0075,00

76

l

Y0000334 Codeine impurity A 3 15 mg 1 7,8-didehydro-4,5 alpha-epoxy-3,6 alpha-dimethoxy-17-methylmorphinan 0074,0075,00

76, 1412

+5°C a

C2500100 Codeine hydrochloride dihydrate - reference spectrum 1 n/a 1 1412 l

C2510000 Codergocrine mesilate 1 60 mg 1 1416,2060 +5°C a

Y0001500 Coix seed HRS 1 1300 mg 1 2454 +5°C a

C2580000 Colchicine 2 15 mg 1 0758 +5°C g

Y0000209 Colchicine for system suitability 2 10 mg 1 0758 Yes +5°C g

Y0000374 Colestyramine 1 10 mg 1 1775 +5°C a

C2600000 Colistimethate sodium 2 20 mg 1 285000 IU per vial C—‡HŒŒ—NŒÿNa—Oœ‡S— 0319,20702 +5°C a

Y0000277 Colistin sulfate 3 25 mg 1 33.7% colistin E2, 2.6% colistin E3, 3.3% colistin E1-I, 3.1% colistinE1-7MOA, 44.2 % colistin E1.25.0 mg of colistin sulphate per vial

0320 Yes -20°C g

C2700000 Colistin sulfate for microbiological assay 2 25 mg 1 576 000 IU per vial; For microbiological assay only 0320 Yes -20° C g

C2725000 Copovidone - reference spectrum 1 n/a 1 0891 l

C2800000 Cortisone acetate 6 250 mg 1 0321,0736,07

67

+5°C a

Y0000438 Coumarin 1 80 mg 1 99.9% C„HÿOœ 2120 +5°C g

C2900000 Cotton wool standard for neps 1 1000 mg 1 0036 +5°C a

Y0001053 Crospovidone 1 5 mg 1 0892 +5°C a

C2970000 Crotamiton 2 100 mg 1 99.2% CŒ–HŒŸNO (sum of E and Z-isomers); 3.5% Z-isomers 1194 -20°C c

C2970005 Crotamiton impurity A 3 70 mg 1 N-ethyl-N-(2-methylphenyl)but-3-enamide 1194 -20°C c

New Y0001061 Cyanidin chloride 2 25 mg 1 93.3% CŒ—HŒŒClOÿ ; Batch 1 is valid until 31 August 2013 2394 Yes +5°C a

C3000000 Cyanocobalamin 4 20 mg 1 Vitamin B12 0269,0270,05

47,

+5°C a

C3090000 Cyclizine hydrochloride 1 50 mg 1 1092 +5°C g

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Y0000886 Cyclizine impurity A 1 20 mg 1 1-methylpiperazine 1092 +5°C g(b)

Y0000887 Cyclizine impurity B 1 10 mg 1 diphenylmethanol (benzhydrol) 1092 +5°C a

C3200000 Cyclobenzaprine hydrochloride 1 100 mg 1 0408,0464 +5°C a

C3230000 Cyclohexa-1,4-dienylglycine 3 15 mg 1 86.7% C‡HŒŒNOœ; (2R)-amino(cyclohexa-1,4-dienyl)acetic acid (d- dihydrophenylglycine) ; Batch 2 is valid until 27 April 2012

0814 Yes -20°C c

C3245000 Cyclopentolate hydrochloride 2 50 mg 2 1093 +5°C a

Y0001088 Cyclopentolate for system suitability 1 60 mg 1 1093 Yes +5°C a

C3250000 Cyclophosphamide 2 50 mg 1 0711 +5°C g

C3280000 Cyproheptadine hydrochloride 1 30 mg 1 0817,0846 +5°C g

Y0001095 Cyproheptadine impurity C 1 5 mg 1 0817 +5°C g

C3283000 Cyproterone acetate 2 30 mg 1 1094 +5°C g

Y0001390 Cyproterone acetate for peak identification 1 5 mg 1 1094 Yes +5°C g

Y0001223 Cyproterone impurity mixture 1 0.01 mg 1 1094 Yes +5°C g

C3290000 Cysteine hydrochloride monohydrate 1 50 mg 1 0895 +5°C g

C3300000 Cystine 2 100 mg 1 0998 +5°C a

C3350000 Cytarabine 1 150 mg 1 0760 +5°C a

Y0000733 Dacarbazine 1 20 mg 1 1691 +5°C b

Y0000734 Dacarbazine impurity A 2 20 mg 1 89.4% C÷H–N—O; 3,7-dihydro-4H-imidazo[4,5-d]-1,2,3-triazin-4-one (2- azahypoxanthine)

1691 Yes +5°C b

Y0000735 Dacarbazine impurity B 1 10 mg 1 87.9% C÷HÿO–; 5-amino-1H-imidazole-carboxamide 1691 Yes +5°C b

D0070000 Dalteparin sodium 2 250 mg 1 0828 +5°C a

Y0000600 Danaparoid sodium 1 200 mg 1 147 anti-factor Xa units per ampoule, 4.3 anti-factor IIa units per ampoule 2090 Yes +5°C b

D0100000 Dapsone 2 100 mg 1 0077 +5°C a

D0125000 Daunorubicin hydrochloride 4 120 mg 1 98.5% CœŸH–ÐClNOŒÐ 0662 Yes +5°C g

D0120000 Daunorubicinone 3 10 mg 1 Daunorubicin aglycone 0662 +5°C g

D0160000 Deferoxamine mesilate 2 30 mg 1 0896 -20°C c

D0201000 Dehydrohexetidine 2 50 mg 1 2-ethyl-N-[[1-(2-ethylhexyl)-4-methyl-4,5-dihydro-1H-imidazol-4-yl]methyl]hexan-1-amine

1221 +5°C a

Y0000611 Dembrexine hydrochloride monohydrate 1 10 mg 1 2169 +5°C a

D0300000 Demeclocycline hydrochloride 4 100 mg 1 92.4% CœŒHœœClœNœO‡ 0176 +5°C a

D0350000 N-Demethylerythromycin A 2 10 mg 1 0179,0274,04

90,

+5°C a

Y0000228 Demethylflumazenil - reference spectrum 1 n/a 1 1917 l

D0406200 Deptropine citrate 1 60 mg 1 1308 +5°C a

D0430000 Dequalinium chloride 1 50 mg 1 1413 +5°C a

D0431000 Dequalinium chloride for performance test 1 50 mg 1 1413 +5°C a

Y0001321 Dermatan sulfate and oversulfated chondroitin sulfate 1 1 mL 1 Dermatan sulfate 10 mg/mLOversulfated chondroitin sulfate 2.5 mg/mL

0332,0333 Yes -20°C c

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D0480000 Desacetylvinblastine 1 1 mg 2 1276 -80°C g(d)

Y0000879 Desflurane - reference spectrum 1 n/a 1 1666 l

Y0000807 Desflurane impurity A 1 1 ml 1 1,1'-oxybis(1,2,2,2-tetrafluoroethane) 1666 +5°C b

D0500000 Desipramine hydrochloride 1 100 mg 1 0481 +5°C g

D0600000 Deslanoside 2 150 mg 1 98.8% C÷ŸHŸ÷OŒ„ 0482 +5°C g

D0630000 Desmethylmetrifonate 1 30 mg 1 1133 +5°C g

D0650000 Desmopressin 8 0.94 mg 1 0.94 mg per vial of C÷ÿHÿ÷NŒ÷OŒœSœ ; Batch 7 is valid until 1 March 2013 0712 Yes -20°C c

Y0000509 Desogestrel 1 50 mg 1 99.9% CœœH–ÐO 1717 Yes +5°C a

Y0000510 Desogestrel for system suitability 1 10 mg 1 1717 Yes +5°C a

D0400000 Desoxycortone acetate 2 100 mg 1 0322,0809,08

50, 1327

+5°C a

Y0000001 Detomidine hydrochloride 2 100 mg 1 1414 +5°C g

D0660020 Detomidine impurity B 1 20 mg 1 (RS)-(1-benzyl-1H-imidazol-5-yl)(2,3-dimethylphenyl)methanol 1414 +5°C g

D0700000 Dexamethasone 5 50 mg 1 Batch 4 is valid until 31 August 2012 0312,0388,05

48,

0768,1376,22

37,0549

+5°C a

D0710000 Dexamethasone acetate 3 100 mg 1 0548,0933,09

75, 2237

+5°C a

Y0001169 Dexamethasone acetate impurity E 1 0.013 mg 1 9-fluoro-11beta,17-dihydroxy-16alpha-methyl-3,20-dioxopregn-4-en-21-yl acetate 0548 +5°C a

Y0001177 Dexamethasone for system suitability 1 10 mg 1 0388 Yes +5°C a

Y0000538 Dexamethasone isonicotinate 1 10 mg 1 2237 +5°C a

Y0000511 Dexamethasone isonicotinate for impurity C identification 1 10 mg 1 2237 Yes +5°C a

D0718000 Dexamethasone pivalate 1 50 mg 1 1327 +5°C a

D0720000 Dexamethasone sodium phosphate 5 100 mg 1 88.3 % CœœHœ‡FNaœO‡P; Dexamethasone sodium phosphate CRS 4 is suitable for 01/2008:0810, 01/2008:0549 and 01/2008:0735 only. ; Batch 4 is valid until 31 October 2012

0549,0735,08

10

Yes +5°C a

Y0001477 Dexamethasone sodium phosphate for peak identification 1 10 mg 1 0549 Yes +5°C a

D0720800 Dexchlorpheniramine maleate 1 60 mg 1 1196 +5°C g

D0730000 Dexpanthenol 4 5 mg 1 0761 +5°C a

D0731000 Dextran 1 25 mg 1 0999,1000,10

01

+5°C a

D0731005 Dextran 1 1 50 mg 1 Average molecule mass : 930-1000Fraction with less than 3 glucose units : 8.0 to 10.5% Fraction with more than 9 glucose units : 10.0 to 12.5%

1506 Yes +5°C a

D0732000 Dextran Vo 1 10 mg 1 20239 +5°C a

D0733000 Dextran 4 for calibration 1 50 mg 1 M™´¨ 3050-Mö 3850 20239 +5°C a

D0734000 Dextran 10 for calibration 1 50 mg 1 M™´¨ 8800 - Mö 10450 20239 +5°C a

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D0735000 Dextran 40 for calibration 1 50 mg 1 M™´¨ 30500- Mö 40900 20239 +5°C a



D0738000 Dextran 40 for performance test 1 50 mg 1 20239 +5°C a

D0739000 Dextran 60/70 for performance test 1 50 mg 1 20239 +5°C a

Y0000744 Dextranomer 1 50 mg 1 2338 +5°C a

D0740000 Dextromethorphan hydrobromide 4 100 mg 1 Batch 3 is valid until 31 January 2013 0020 +5°C g

Y0000261 Dextromethorphan impurity A 1 5 mg 1 ent-3-methoxymorphinan 0020 +5°C g

Y0001058 Dextropropoxyphene hydrochloride - * narc 1 10 mg 1 0713 +5°C k

Y0001150 Dextropropoxyphene for system suitability - * narc 1 5 mg 1 0713 Yes +5°C k

D0940000 Diazepam - * psy 1 30 mg 1 0022 +5°C j

Y0000596 Diazepam for system suitability - * psy 2 0.5 mg 1 Batch 1 is valid until 31 August 2012 0022 Yes +5°C j

D0950000 Diazoxide 1 50 mg 1 0550 +5°C a

D0970000 Dibenzocycloheptene 2 20 mg 1 0817 +5°C g

D1000000 Dibenzosuberone 1 100 mg 1 0464,0817,09

41

+5°C a

Y0000480 Dibrompropamidine diisetionate 1 10 mg 1 2300 +5°C a

Y0000481 Dibrompropamidine for system suitability 1 20 mg 1 2300 Yes +5°C a

D1010000 Dibutyl phthalate 1 1 ml 1 0762 +5°C g

Y0000275 Dichlorodiaminocyclohexaneplatinum 4 15 mg 1 Batch 3 is valid until 1 April 2013 2017 +5°C g

Y0000264 Diclazuril for veterinary use - reference spectrum 1 n/a 1 1718 l

Y0000259 Diclazuril for system suitability 1 20 mg 1 1718 +5°C g

D1039990 Diclofenac potassium 2 100 mg 1 1508 +5°C g

D1040000 Diclofenac impurity A 7 0.005 mg 1 1-(2,6-dichlorophenyl)-1,3-dihydro-2H-indol-2-one 1002,1281,15

08

+5°C g

D1050000 Dicloxacillin sodium 5 250 mg 1 94.7% CŒ„HŒÿClœN–NaO—S ; Batch 4 is valid until 31 July 2012 0661,0663,06

68

Yes +5°C a

D1060000 Dicycloverine hydrochloride 2 100 mg 1 1197 +5°C a

Y0000439 Didanosine 1 10 mg 1 2200 +5°C a

Y0000440 Didanosine for system suitability 1 10 mg 1 2200 Yes +5°C a

Y0000441 Didanosine impurity A 1 10 mg 1 1,7-dihydro-6H-purin-6-one (hypoxanthine) 2200 +5°C a

Y0000442 Didanosine impurity G 1 10 mg 1 9-(2,3-dideoxy-ß-D-glycero-pentofuranosyl)-9H-purin-6-amine (2',3'- dideoxyadenosine)

2200 +5°C a

D1200000 Dienestrol 3 150 mg 1 100% CŒ‡HŒ‡Oœ 0483,0484 +5°C a

D1300000 Diethylcarbamazine citrate 2 250 mg 1 99.9% CŒÿHœ„N–O‡ 0271 +5°C g

Y0000217 Diethylene glycol (monoethyl ether) - reference spectrum 1 n/a 1 1198 l

D1410000 Diethyl phthalate 1 1 ml 1 0897 +5°C a

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D1500000 Diethylstilbestrol 1 100 mg 1 Dried at 100-105°C for 2 h. 100% CŒ‡HœÐOœ 0483,0484 +5°C a

D1600000 Diethylstilbestrol dimethyl ether 1 10 mg 1 0484 +5°C a

D1700000 Diethylstilbestrol monomethyl ether 1 10 mg 1 0484 +5°C a

Y0001423 Difloxacin hydrochloride 1 60 mg 1 2239 +5°C a

Y0001429 Difloxacin impurity G 1 15 mg 1 7-chloro-6-fluoro-1-(4-fluorophenyl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid

2239 +5°C a

D1750000 Diflunisal 1 30 mg 1 0818,0864 +5°C a

D1800000 Digitoxin 3 200 mg 1 99.4% C÷ŒHÿ÷OŒ– ; Batch 2 is valid until 30 October 2012 0078,0117 Yes +5°C g

Y0000640 Digoxigenin 1 5 mg 1 0079 +5°C f

D1900000 Digoxin 7 30 mg 1 98.5% C÷ŒHÿ÷OŒ÷ 0079 +5°C g

Y0000554 Digoxin for peak identification 1 10 mg 1 0079 Yes +5°C g

D1940001 Dihydralazine sulfate (hydrated) - reference spectrum 1 n/a 1 1310 l

Y0000232 Dihydralazine for system suitability 1 10 mg 1 1310 Yes +5°C a

Y0000216 Dihydrocodeine hydrogen tartrate - reference spectrum 1 n/a 1 1776 l

Y0000053 17 alpha-dihydroequilin 1 10 mg 1 98.2% CŒ‡HœœOœ 1512 -20°C c

D1945000 Dihydroergocristine mesilate 2 250 mg 1 1416,2060 +5°C a

D1950000 Dihydroergotamine mesilate 3 100 mg 1 0551 +5°C a

Y0000831 Dihydroergotamine for peak identification 1 10 mg 1 0551 Yes +5°C a

D1952000 Dihydroergotamine tartrate 2 150 mg 1 100.0% CŸÐH‡ÐNŒÐOŒÿ. Dried at 100-105°C at constant weight 0600 +5°C a

D1954000 Dihydrostreptomycin sulfate 4 25 mg 1 23.9 mg per vial of C÷œH‡‡NŒ÷O–ÿS– 0485 Yes -20°C a

Y0000544 Dihydrotachysterol 2 30 mg 1 99.6% Cœ‡H÷ÿO 2014 -20°C g(d)

Y0000482 Dihydrotachysterol for system suitability 1 5 mg 1 2014 Yes -20°C g(d)

D1980000 Diltiazem hydrochloride 5 300 mg 1 1004 +5°C g

New Y0001141 Diltiazem for system suitability 2 10 mg 1 Replaces Diltiazem impurity A CRS ; Batch 1 is valid until 31 August 2013 1004 +5°C g

Y0001439 Diltiazem impurity F 1 10 mg 1 (2S,3S)-5-[2-(dimethylamino)ethyl]-3-hydroxy-2-(4-methoxyphenyl)-2,3- dihydro-1,5-benzothiazepin-4(5H)-one

1004 +5°C g

D2000000 Dimenhydrinate 1 100 mg 1 0601 +5°C a

Y0000234 N,N-Dimethylacetamide - reference spectrum 1 n/a 1 1667 l

Y0001103 Dimenhydrinate for peak identification 1 1 mg 1 0601 Yes +5°C a

D2050000 Dimethyl sulfoxide 2 1 ml 1 0763 +5°C a

Y0001489 2-(Dimethylamino)ethyl methacrylate 1 50 mg 1 1975 +5°C g

D2200000 Dimeticone 4 200 mg 1 99.9% dimeticone 0138,1470 Yes +5°C a

D2205000 Dimetindene maleate 1 50 mg 1 1417 +5°C a

D2255000 Dinoprost trometamol 1 60 mg 1 98.2% Cœ÷H÷—NO‡ 1312 -20°C c

D2250000 Dinoprostone 2 100 mg 1 99.8% CœÐH–œO 1311 -20°C c

D2250015 Dinoprostone impurity C 2 10 mg 1 (E)-7-[(1S,2R,3R)-3-hydroxy-2-[(E)-(3S)-3-hydroxyoct-1-enyl]- 5- oxocyclopentyl]-hept-5-enoic acid (5-trans-PGE2 ; (5E)-PGE2)

1311,1488 -20°C c

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Y0000094 Diosmin 3 70 mg 1 90.9% Cœ‡H–œOŒ— ; Batch 2 is valid until 31 August 2012 1611 Yes +5°C a

Y0000095 Diosmin for system suitability 2 5 mg 1 1611 +5°C a

D2600000 Diphenhydramine hydrochloride 1 100 mg 1 0023,0601,11

90

+5°C a

Y0000135 Diphenhydramine impurity A 3 10 mg 1 2-(diphenylmethoxy)-N-methylethanamine 0023,0601 +5°C a

D2630000 Diphenoxylate hydrochloride - reference spectrum 1 n/a 1 0819 l

Y0001415 Diphenoxylate hydrochloride - * narc 1 15 mg 1 0819 +5°C k

Y0001430 Diphenoxylate for system suitability - * narc 1 10 mg 1 0819 +5°C j

Y0000258 Diphtheria toxin BRP 1 1 ml 1 Nominal concentration of Diphtheria toxin: 1 Lf/ml (0.4µl/ml)Systemic toxicity: 77.6 LD—Ð/ml (determined in the subcutaneous challenge test in guinea pigs)Maximum intradermal toxicity: 75,000Lr/Lf (determined in the guinea pig intradermal skin test)Toxicity in the Vero cell assay: concentrations of 5x10-Î Lf/ml and below cause cytotoxic effects.

See leaflet,

0443

Yes +5°C g(b)

D2700000 Diphtheria vaccine (adsorbed) BRP 4 32 mg 1 97 IU per vial See leaflet,

20706

Yes -20°C c

Y0000376 Dipivefrine hydrochloride 1 100 mg 1 1719 +5°C g

Y0000394 Dipivefrine for system suitability 1 10 mg 1 1719 +5°C g

D2750100 Dipotassium clorazepate - reference spectrum 1 n/a 1 0898 l

D2800000 Diprophylline 1 100 mg 1 0486 +5°C a

D2850000 Dipyridamole 1 50 mg 1 1199 +5°C a

Y0000802 Dipyridamole for peak identification 2 2.04 mg 1 Batch 1 is valid until 30 September 2012 1199 Yes +5°C a

D2880000 Dirithromycin 1 100 mg 1 97.4% C÷œHŸ‡NœOŒ÷ 1313 +5°C a

D2900000 Disodium edetate 1 100 mg 1 0232 +5°C a

D2920000 Disopyramide 1 100 mg 1 1006 +5°C a

D2922000 Disopyramide phosphate 1 100 mg 1 1005 +5°C a

D2950000 Disulfiram 1 100 mg 1 0603 +5°C g

D2953000 Dithranol 2 55 mg 1 Batch 1 is valid until 31 December 2012 1007 +5°C g

D2953025 Dithranol impurity C 3 15 mg 1 Dithranol-dimer4,4',5,5'-tetrahydroxy-9,9'-bianthracenyl-10,10'(9H,9'H)-dione ; Batch 2 is valid until 1 June 2013

1007 Yes +5°C g

D2953050 Dithranol impurity D 3 20 mg 1 94.9% CŒ÷HŒÐOœ; 1-hydroxyanthracen-9(10H)-one 1007 +5°C g

D2954000 Dobutamine hydrochloride 1 100 mg 1 1200 +5°C a

Y0001239 Dobutamine impurity mixture 1 0.1 mg 1 1200 Yes +5°C a

Y0001133 Docetaxel trihydrate 1 160 mg 1 93.6% C÷–H—–NOŒ÷ 2449,2593 +5°C a

Y0001155 Docetaxel for system suitability 2 10 mg 1 Batch 1 is valid until 1 March 2013 2449,2593 Yes +5°C a

Y0001452 Docetaxel impurity E 1 15 mg 1 5ß,20-epoxy-4-(acetyloxy)-1,7ß,10ß,13¶-tetrahydroxy-9-oxotax-11-en-2¶-yl benzoate (10-desacetyl-baccatin III)

2593 +5°C a

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D2954600 Docosahexaenoic acid ethyl ester 4 150 mg 1 93.1% DHA ethyl ester ; Batch 3 is valid until 7 May 2012 2063,20429 Yes -20°C c

D2954500 Docusate sodium - reference spectrum 1 n/a 1 1418 l

Y0000365 Dodecyl gallate 1 30 mg 1 2078 +5°C a

D2955000 Domperidone 2 150 mg 1 1009 +5°C a

D2957000 Domperidone maleate 1 150 mg 1 1008 +5°C a

D2960000 Dopamine hydrochloride 1 50 mg 1 0664,1200 +5°C g

Y0000612 Dopexamine dihydrochloride 1 10 mg 1 1748 +5°C a

Y0000613 Dopexamine impurity B 1 10 mg 1 2-methoxy-4-[2-[[6-[(2-phenylethyl)amino]hexyl]amino]ethyl]phenol 1748 -20°C c

Y0000614 Dopexamine impurity F 1 10 mg 1 4-chloro-5-[2-[[6-[(2-phenylethyl)amino]hexyl]amino]ethyl]benz -ene-1,2-diol 1748 -20°C c

Y0000726 Dorzolamide hydrochloride 1 50 mg 1 2359 +5°C a

Y0000727 Dorzolamide impurity A 1 5 mg 1 (4R,6R)-4-(ethylamino)-6-methyl-5,6-dihydro-4H-thieno[2,3-b]thiopyran-2- sulphonamide 7,7-dioxide

2359 +5°C a

Y0000750 Dorzolamide for system suitability 1 5 mg 1 2359 Yes +5°C a

D2962000 Dosulepin hydrochloride 1 100 mg 1 1314 +5°C g

D2962005 Dosulepin impurity A 1 50 mg 1 (E)-3-(6,11-dihydrodibenzo[b,e]thiepin-11-ylidene)-N,N'- dimethylpropan-1-amine £-oxide

1314 +5°C g

Y0001385 Angelica pubescent root 1 500 mg 1 2557 Yes +5°C a

D2963000 Doxapram hydrochloride 1 50 mg 1 1201 +5°C g

Y0000208 Doxapram impurity B 1 10 mg 1 (4RS)-1-ethyl-4-[2-[(2-hydroxyethyl)amino]ethyl]-3,3-diphenylpyrolidin-2-one 1201 +5°C g

Y0000553 Doxazosin mesilate 1 60 mg 1 99.2% Cœ÷Hœ„N—O‡S 2125 +5°C a

Y0000551 Doxazosin impurity D 1 10 mg 1 6,7-dimethoxyquinazoline-2,4(1H,3H)-dione 2125 +5°C a

Y0000552 Doxazosin impurity F 1 10 mg 1 2-chloro-6,7-dimethoxyquinazolin-4-amine 2125 +5°C a

Y0000838 Doxepin hydrochloride 1 5 mg 1 1096 +5°C g

Y0000851 Doxepin for system suitability 1 1 mg 1 1096 Yes +5°C g

D2975000 Doxorubicin hydrochloride 6 150 mg 1 99.4% CœŸH–ÐClNOŒŒ ; Batch 5 is valid until 31 May 2012 0714,0662,15

90

Yes -20°C g(c)

D3000000 Doxycycline hyclate 4 50 mg 1 92.9% CœœHœ—ClNœO‡ corresponding to 85.9% CœœHœ÷NœO‡ 0272,0820 Yes +5°C a

Y0001492 Doxylamine for system suitability 1 100 mg 1 1589 Yes +5°C a

Y0000163 Doxylamine hydrogen succinate - reference spectrum 1 n/a 1 1589 l

Y0000160 Doxylamine impurity A 2 10 mg 1 N,N-dimethyl-2-[1(RS)-1-phenyl-1-(pyridin-4-yl)ethoxy]ethanamine ; Batch 1 is valid until 30 April 2012

1589 +5°C a

D3100000 Droperidol 2 150 mg 1 1008,1009,10

10, 1172

+5°C a

Y0001105 Drospirenone 1 60 mg 1 99.9% Cœ÷H–ÐO– 2404 +5°C g

Y0001115 Drospirenone impurity E 1 0.06 mg 1 3-oxo-6alpha,7alpha,15alpha,16alpha-tetrahydro-3'H,3''H-dicyclopropa[6,7:15,16]pregn-4-ene-21,17- carbolactone (17-epidrospirenone)

2404 +5°C g

Y0001453 Duloxetine hydrochloride 1 120 mg 1 99.8 % CŒ‡HœÐClNOS 2594 Yes +5°C g

Y0001454 Duloxetine for system suitability 1 40 mg 1 2594 Yes +5°C g

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Y0001455 Duloxetine impurity A 1 10 mg 1 (3R)-N-methyl-3-(naphthalen-1-yloxy)-3-(thiophen-2-yl)propan-1-amine 2594 +5°C g

Y0001004 Dydrogesterone 1 50 mg 1 99.5% CœŒHœ‡Oœ 2357 +5°C a

Y0001005 Dydrogesterone impurity A 1 6 mg 1 9ß,10-pregna-4,6,8(14)-triene-3,20-dione 2357 +5°C a

Y0001006 Dydrogesterone impurity B 1 5 mg 1 pregna-4,6-diene-3,20-dione 2357 +5°C a

Y0000249 Ebastine - reference spectrum 1 n/a 1 2015 l

Y0000247 Ebastine impurity C 1 10 mg 1 4-(diphenylmethoxy)piperidine 2015 +5°C a

Y0000248 Ebastine impurity D 1 10 mg 1 1-[4-(1,1-dimethylethyl)phenyl]-4-(4-hydroxypiperidin-1-yl)butan-1-one 2015 +5°C a

Y0001236 Econazole 1 10 mg 1 2049 +5°C a

E0050000 Econazole nitrate 3 100 mg 1 0513,0665,09

21, 0935,

1017,1018

+5°C a

Y0000254 Econazole for system suitability 1 20 mg 1 0665,2049 Yes +5°C a

E0085000 Eicosapentaenoic acid ethyl ester 3 200 mg 1 93.6% EPA ethyl ester CœœH–÷Oœ 2063,20429 Yes -20°C c

Y0000537 Emedastine difumarate 1 10 mg 1 2242 +5°C a

Y0000512 Emedastine impurity E 1 10 mg 1 1-(2-ethoxyethyl)-2-(hexahydro-1H-1,4-diazepin-1yl)benzimidazole. 2242 +5°C a

E0100000 Emetine hydrochloride 2 100 mg 1 0080,0081,00

93,

0094,1530,18

75

+5°C f

E0110000 Enalapril for system suitability 1 20 mg 1 1420 +5°C a

Y0001211 Enalapril impurity mixture 1 0.06 mg 1 1420 Yes +5°C a

E0109000 Enalapril maleate 2 50 mg 1 1420 +5°C a

Y0000615 Enalaprilat dihydrate 1 100 mg 1 1749 +5°C a

Y0000629 Enalaprilat for system suitability 1 10 mg 1 1749 Yes +5°C a

Y0000678 Enalaprilat impurity G 1 0.005 mg 1 (2SR)-2-[(3SR,8aRS)-3-methyl-1,4-dioxohexahydropyrrolo[1,2-a] pyrazin-2 (1H)-yl]-4-phenylbutanoic acid

1749 +5°C a

Y0000136 Enilconazole 1 60 mg 1 1720 +5°C g

Y0000137 Enilconazole impurity E 1 20 mg 1 (1RS)-1-(2,4-dichlorophenyl)-2-(-1H-imidazol-1-yl)ethanol 1720 +5°C g

E0150000 Endotoxin standard BRP 5 10 mg 1 10 000 IU per vial ; Batch 4 is valid until 31 December 2012 20614 Yes -20°C a

E0180000 Enoxaparin sodium 4 200 mg 1 0828,1097 +5°C a

E0180500 Enoxolone 1 100 mg 1 1511 +5°C a

Y0001259 Enrofloxacin 1 5 mg 1 2229 +5°C g

New Y0001160 Enrofloxacin for system suitability 1 10 mg 1 2229 Yes +5°C g

Y0001249 Entacapone 1 160 mg 1 99.9% CŒ÷HŒ—N–O— 2574 Yes +5°C a

Y0001250 Entacapone impurity A 1 10 mg 1 Z isomer of entacapone 2574 +5°C a

E0200000 Enterokinase BRP 1 200 mg 1 0350 +5°C a

E0305000 Ephedrine hydrochloride (racemic) - * Drug Precursor 1 50 mg 1 0715 +5°C i

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E0300000 Ephedrine hydrochloride - * Drug Precursor 2 150 mg 1 99.8% CŒÐHŒÿClNO 0487,0488,04

89,

Yes +5°C i

E0400000 4-Epianhydrotetracycline hydrochloride 6 20 mg 1 87.1% CœœHœœNœOŸ.HCl 0210,0211,16

54

Yes +5°C a

E0440000 4-Epidemeclocycline hydrochloride 1 20 mg 1 0176 +5°C a

E0500000 6-Epidoxycycline hydrochloride 5 50 mg 1 0272,0820 +5°C a

Y0001139 Epinastine hydrochloride 1 20 mg 1 2411 +5°C g

Y0001128 Epinastine hydrochloride for system suitability 1 10 mg 1 2411 Yes +5°C g

E0530000 4-Epioxytetracycline 7 40 mg 1 81.1% CœœHœ÷NœO„ 0198,0199 +5°C g

E0550000 Epirubicin hydrochloride 6 100 mg 1 96.4% CœŸH–ÐClNOŒŒ 0662,0714,15

90

Yes -20°C c

E0600000 4-Epitetracycline hydrochloride 8 30 mg 1 0210,0211,16

54

+5°C a

Y0000052 Equilin 1 15 mg 1 99.7% CŒ‡HœÐOœ 1512 -20°C c

Y0001325 Equisetum palustre 1 200 mg 1 1825 +5°C a

E0850010 Eq Influenza Subtype 1 Strain A/eq/Newmarket/77 Horse

Antiserum BRP

2 1 mg 3 Assigned SRH antibody titre: 125 mmË +/-20%; Common standard OIE Strain A/eq/Newmarket/77

See leaflet,

0249

Yes -20°C c

E0850021 Eq Influenza Subtype 2 American-like/Newmarket Horse

Antiserum BRP

2 1 mg 3 Assigned SRH antibody titre: 180 mmË +/- 20%; Common standard OIE Strain A/eq/Newmarket/1/93

See leaflet,

0249

Yes -20°C c

E0850022 Eq Influenza Subtype 2 European-like/Newmarket Horse

Antiserum BRP

2 1 mg 3 Assigned SRH antibody titre: 155 mmË +/- 20%; Common standard OIE Strain A/eq/Newmarket/2/93

See leaflet,

0249

Yes -20°C c

Y0000712 Eq Influenza Subtype 2 American-like/South Africa Horse

Antiserum BRP

1 1 mg 3 See leaflet,

0249

Yes -20°C c

New E0900000 Ergocalciferol 8 500 mg 1 99.7% Cœ‡H÷÷O ; Vitamin D2 ; Batch 7 is valid until 31 August 2013 0082,0574,05

75,

0598,1192,11

93

Yes -20°C g(c)

E1000000 Ergometrine maleate - * Drug Precursor 2 50 mg 1 0223 +5°C i

E1100000 Ergosterol 5 20 mg 1 0082 -20°C g(c)

E1200000 Ergotamine tartrate - * Drug Precursor 2 100 mg 1 0224, 0551 +5°C i

Y0000051 Erysipelas ELISA coating antigen BRP 1 0.4 mg 1 0.5ml Freeze dried (0.367g protein) See leaflet,

0064

Yes -20°C c

Y0000177 Erythritol 1 1000 mg 1 99.8% C÷HŒÐO÷ 1803 Yes +5°C a

E1300000 Erythromycin for microbiological assay 4 250 mg 1 960 IU per mg 20702 -20°C a

E1305000 Erythromycin A 3 250 mg 1 97.0% C–ŸHÿŸNOŒ– 0179,0274,02

93,

0490,0552,10

98

Yes -20°C g

E1310000 Erythromycin B 3 50 mg 1 98.4% C–ŸHÿŸNOŒœ 0179,0274,04

90,

-20°C g

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E1320000 Erythromycin C 4 50 mg 1 97.6% C–ÿHÿ—NOŒ– 0179,0274,04

90,

Yes -20°C g

E1400000 Erythromycin estolate 1 100 mg 1 0552 +5°C g

E1500000 Erythromycin ethylsuccinate 2 10 mg 1 0274 +5°C g

E1500800 Erythromycin stearate 1 50 mg 1 0490 +5°C g

E1515000 Erythropoietin BRP 3 37.5 mg 1 35280 IU per vial 1316 Yes -20°C a

Y0000324 Esketamine hydrochloride - reference spectrum 1 n/a 1 1742 l

Y0000338 Esketamine impurity D 1 10 mg 1 (2R)-2-(2-chlorophenyl)-2-(methylamino)cyclohexanone ((R)-ketamine) 1742 +5°C a

Y0001028 Esomeprazole magnesium trihydrate 1 10 mg 1 2372 +5°C a

Y0000749 Essential oil 1 1000 mg 1 2098 Yes +5°C g

E1600000 Estradiol benzoate 1 250 mg 1 0139 +5°C a

Y0000852 Estradiol benzoate for system suitability 1 10 mg 1 0139 Yes +5°C a

Y0000045 Estradiol butyrate 1 10 mg 1 1614 +5°C a

E1620000 Estradiol hemihydrate 3 100 mg 1 0821,1203 +5°C a

Y0000314 Estradiol for peak identification 1 10 mg 1 0821 Yes +5°C a

Y0000046 Estradiol valerate 1 50 mg 1 1614 +5°C a

E1680000 Estriol 2 50 mg 1 1203 +5°C a

New E1680005 Estriol impurity A 2 20 mg 1 9,11-didehydroestriol ; Batch 1 is valid until 31 August 2013 1203 +5°C a

E1700000 Estrone 4 15 mg 1 100.0% CŒ‡HœœOœ 1512,0140 Yes +5°C a

E1800000 Etacrynic acid 1 100 mg 1 0457 +5°C a

Y0001263 Etacrynic acid for system suitability 1 10 mg 1 0457 Yes +5°C a

E1830000 Etamsylate 1 30 mg 1 1204 +5°C a

E1840000 Ethacridine lactate monohydrate 1 50 mg 1 1591 +5°C a

E1850000 Ethambutol hydrochloride 3 250 mg 1 0553 +5°C a

Y0000803 Ethambutol for system suitability 1 10 mg 1 0553 +5°C a

A1202800 Ethanol (anhydrous) - reference spectrum 1 n/a 1 1318 l

E1860100 Ethanol 96% - reference spectrum 1 n/a 1 1317 l

E1900000 Ethinylestradiol 4 200 mg 1 0140,0821,09

40

Yes +5°C g

Y0001124 Ethinylestradiol for system suitability 2 1.0124 mg 1 Batch 1 is valid until 1 May 2013 0140 Yes +5°C g

E2000000 Ethionamide 1 100 mg 1 0141 +5°C a

E2150000 Ethosuximide 1 30 mg 1 0764 +5°C a

E2250000 Ethosuximide impurity A 4 30 mg 1 (2RS)-2-ethyl-2-methylbutanedioic acid 0764 +5°C a

E2195000 Ethyl acetate - reference spectrum 1 n/a 1 0899 l

E2195900 Ethylcellulose - reference spectrum 1 n/a 1 0822 l

E2202000 1-N-Ethylgaramine sulfate 3 50 mg 1 77.6% of 1-N-Ethylgaramin sulphate ; Batch 2 is valid until 18 September 201 1351 Yes +5°C a

E2205500 1,1'-Ethylidenebistryptophan 5 0.002 mg 2 0.00182mg per vial of Cœ÷HœÿN÷O÷ ; Batch 4 is valid until 1 May 2013 1272,1383 Yes +5°C g

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Y0000617 Ethyl indole-3-carboxylate 1 10 mg 1 2102 +5°C a

E2300000 Ethylmorphine hydrochloride - reference spectrum 1 n/a 1 0491 l

E2400000 Ethylnicotinamide 1 150 mg 1 0233 +5°C g

E2425000 Ethyl parahydroxybenzoate 3 150 mg 1 100.0% C„HŒÐO–; batch 2 valid until 31/12/10 excepted for use with monograph 0900.

0409,0431,09

00,

1262,1263,21

34

+5°C a

E2450000 Etifenin 1 25 mg 1 0585 +5°C a

E2451000 Etilefrine hydrochloride 1 75 mg 1 1205 +5°C g

E2451010 Etilefrine impurity A 1 20 mg 1 2-ethylamino-1-(3-hydroxyphenyl)ethanone 1205 +5°C g

Y0000572 Etidronate disodium 1 10 mg 1 1778 +5°C a

E2470000 Etodolac 1 60 mg 1 1422 +5°C g

E2470050 Etodolac impurity H 1 10 mg 1 2-(7-ethylindol-3-yl)ethanol 1422 +5°C g

Y0000768 Etodolac for peak identification 1 10 mg 1 1422 Yes +5°C g

E2499900 Etofenamate 1 40 mg 1 1513 +5°C g

E2499901 Etofenamate for peak identification 2 20 mg 1 1513 Yes +5°C g

E2499914 Etofenamate impurity G 1 20 mg 1 2-hydroxyethyl 2-[[3-(trifluoromethyl)phenyl]amino]-benzoate 1513 +5°C g

E2500000 Etofylline 1 100 mg 1 0492 +5°C a

E2503000 Etomidate 2 50 mg 1 1514 +5°C a

E2503004 Etomidate impurity B 1 25 mg 1 methyl 1-[(1RS)-1-phenylethyl]-1H-imidazole-5-carboxylate 1514 +5°C a

E2600000 Etoposide 5 150 mg 1 98.4% Cœ„H–œOŒ– 0823 +5°C a

Y0001365 Etoposide for for system suitability 1 10 mg 1 0823 Yes +5°C a

E5000000 Eugenol 2 500 µl 1 1100 +5°C a

F0005000 Famotidine 2 100 mg 1 1012 +5°C a

Y0000382 Famotidine for system suitability 1 10 mg 1 1012 Yes +5°C a

Y0000409 Famotidine impurity D 2 10 mg 1 3-[[[2-[(diaminomethylene)amino]thiazol-4-yl]methyl]sulphanyl]propanamide 1012 +5°C a

Y0000556 Febantel 1 110 mg 1 99.9% CœÐHœœN÷OÿS 2176 +5°C a

Y0000660 Febantel for system suitability 1 10 mg 1 2176 +5°C a

Y0000731 Felbinac 1 10 mg 1 2304 +5°C g

Y0000732 Felbinac impurity A 1 20 mg 1 4-acetyl biphenyl 2304 +5°C a

F0030000 Felodipine 2 120 mg 1 1013 +5°C g

Y0000415 Felypressin 1 0.994 mg 1 0.994 mg C÷ÿHÿ—NŒ–OŒŒSœ 1634 Yes -20°C c

F0040000 Fenbendazole 2 150 mg 1 1208,1458 +5°C g

F0040010 Fenbendazole impurity A 1 20 mg 1 methyl(1§-benzimidazol-2-yl)carbamate 1208 +5°C g

F0040020 Fenbendazole impurity B 1 20 mg 1 methyl[5(6)-chlorobenzimidazol-2-yl]carbamate 1208 +5°C g

F0041000 Fenbufen 1 100 mg 1 1209 +5°C g

F0048000 Fenofibrate 3 100 mg 1 100.0% CœÐHœŒClO÷ 1322 +5°C a

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F0048005 Fenofibrate impurity A 3 20 mg 1 (4-chlorophenyl)(4-hydroxyphenyl)methanone 1322 +5°C a

F0048010 Fenofibrate impurity B 4 10 mg 1 2[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoic acid (fenofibric acid) 1322 +5°C a

F0048035 Fenofibrate impurity G 4 25 mg 1 1-methylethyl 2-[[2-[4-(4-chlorobenzoyl)phenoxy]-2-methylpropanoyl]oxy]-2-methylpropanoate

1322 +5°C a

Y0000756 Fenoterol for peak identification 1 1.2 mg 1 0901 +5°C a

F0050000 Fenoterol hydrobromide 2 100 mg 1 contains 1.3% of impurity A 0901 +5°C a

F0054990 Fentanyl - reference spectrum 1 n/a 1 1210 l

Y0001509 Fentanyl for system suitability - * narc 1 25 mg 1 1210 Yes +5°C k

F0055000 Fentanyl citrate - reference spectrum 1 n/a 1 1103 l

F0060000 Fenticonazole nitrate 1 50 mg 1 1211 +5°C a

F0060040 Fenticonazole impurity D 1 20 mg 1 (¢£)-1-[2-(2,4-dichlorophenyl)-2-hydroxyethyl]-3-[4-(phenyl suphanyl)benzyl]imidazolium nitrate

1211 +5°C a

F0100000 Ferrous gluconate 1 100 mg 1 0493 +5°C a

Y0001013 Ferulic acid 1 20 mg 1 99.8% CŒÐHŒÐO÷ 1834,2558 Yes +5°C a

Y0000789 Fexofenadine hydrochloride 1 60 mg 1 99.8% C–œH÷ÐClNO÷ 2280 +5°C a

Y0000751 Fexofenadine impurity A 1 5 mg 1 2-[4-[4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butanoyl]phenyl]-2- methylpropanoic acid

2280 +5°C a

Y0000752 Fexofenadine impurity B 1 0.01 mg 1 2-[3-[(1RS)-1-hydroxy-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]butyl]phenyl]-2-methylpropanoic acid

2280 +5°C a

Y0000753 Fexofenadine impurity C 1 5 mg 1 (1RS)-4-[4-(hydroxydiphenylmethyl)piperidin-1-yl]-1-[4-(1-methylethyl)phenyl]butan-1-ol

2280 +5°C a

Y0001173 Filgrastim 1 0.2 ml 1 1.95 mg per ml of C‡÷—HŒ––„Nœœ–Oœ÷–S„ 2206 Yes -80°C d

Y0000090 Finasteride 2 60 mg 1 99.7% Cœ–H–ÿNœOœ 1615 +5°C a

New Y0000091 Finasteride for system suitability 3 120 mg 1 Contains 0.9% of impurity A ; Batch 2 is valid until 31 August 2013 1615 Yes +5°C a

Y0000736 Flavoxate hydrochloride 1 10 mg 1 1692 +5°C a

Y0000737 Flavoxate impurity A 1 10 mg 1 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylic acid 1692 +5°C a

Y0000738 Flavoxate impurity B 1 10 mg 1 ethyl 3-methyl-4-oxo-2-phenyl-4H-1-benzopyran-8-carboxylate 1692 +5°C a

F0120000 Flecainide acetate 1 200 mg 1 1324 +5°C a

F0120005 Flecainide impurity A 3 50 mg 1 3-[2,5-bis(2,2,2-trifluoroethoxy)phenyl]-1,5,6,7,8,8a-hexahydroimidazo[1,5- a]pyridine ; Batch 2 is valid until 1 May 2013

1324 +5°C a

F0120010 Flecainide impurity B 1 25 mg 1 (RS)-(piperidin-2-yl)methanamine 1324 +5°C a

Y0001274 Flecainide for system suitability 1 10 mg 1 1324 Yes +5°C a

Y0000138 Flubendazole 1 25 mg 1 1721 +5°C a

Y0000139 Flubendazole for system suitability 1 20 mg 1 1721 Yes +5°C a

Y0000892 Flucloxacillin magnesium octahydrate 1 5 mg 1 2346 +5°C a

Y0000889 Flucloxacillin impurity C 1 5 mg 1 6-aminopenicillanic acid 2346 +5°C a

Y0000890 Flucloxacillin impurity D 1 5 mg 1 3-(2-chloro-6-fluorophenyl)-5-methylisoxazole-4-carboxylic acid 2346 +5°C a

Y0000891 Flucloxacillin impurity E 1 5 mg 1 6-aminopenicillanic acid flucloxacillin amide 2346 Yes +5°C a

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F0150000 Flucloxacillin sodium 7 250 mg 1 95.1% CŒ„HŒÿClFN–NaO—S ; Batch 6 is valid until 31 May 2012 0661,0663,06

68,2346

Yes -20°C c

Y0000557 Fluconazole 1 50 mg 1 2287 +5°C a

Y0000558 Fluconazole for peak identification 1 10 mg 1 2287 Yes +5°C a

Y0000573 Fluconazole impurity B 2 10 mg 1 93.2% CŒ—HŒ÷N„OF ; 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

2287 +5°C a

Y0000574 Fluconazole impurity C 2 5 mg 1 1,1'-(1,3-phenylene)di-1H-1,2,4-triazole 2287 +5°C a

F0175000 Flucytosine 1 100 mg 1 0766 +5°C a

Y0001262 Flucytosine for system suitability 1 10 mg 1 0766 +5°C a

Y0000419 Fludarabine phosphate 2 120 mg 1 98.3% CŒÐHŒ–FN—OŸP ; Batch 1 is valid until 30 September 2012 1781 Yes +5°C a

New Y0001536 Fludarabine for system suitability 1 15 mg 1 1781 Yes +5°C a

F0180000 Fludrocortisone acetate 2 100 mg 1 0767 +5°C a

F0188000 Flumazenil - reference spectrum 1 n/a 1 1326 l

Y0000335 Flumazenil impurity B 1 5 mg 1 ethyl 8-hydroxy-5-methyl-6-oxo-5,6-dihydro-4H-imidazo[1,5-a][1,4]benzodiazepine-3-carboxylate

1326 +5°C a

F0189000 Flumequine 1 60 mg 1 1517 +5°C a

F0189020 Flumequine impurity B 2 0.1 mg 1 ethyl(RS)-9-fluoro-5-methyl-1-oxo-6,7-dihydro-1H,5H-benzo[i,j]quinolizine-2-carboxylate

1517 +5°C a

F0188500 Flumetasone pivalate 1 100 mg 1 1327 +5°C a

F0189900 Flunarizine dihydrochloride 3 100 mg 1 0816 +5°C a

Y0000265 Flunarizine dihydrochloride - reference spectrum 1 n/a 1 1722 l

Y0000266 Flunarizine dihydrochloride for system suitability 1 20 mg 1 1722 Yes +5°C a

F0190000 Flunitrazepam - * psy 1 100 mg 1 1280 +5°C j

Y0000169 Flunitrazepam - reference spectrum 1 n/a 1 0717 l

Y0000443 Flunixin meglumine 1 10 mg 1 1696 +5°C f

Y0000444 Flunixin impurity B 1 10 mg 1 2-methyl-3-(trifluoromethyl)aniline 1696 +5°C f

Y0000445 Flunixin impurity C 1 50 mg 1 ethyl 2-chloropyridine-3-carboxylate 1696 +5°C f

F0200000 Fluocinolone acetonide 3 100 mg 1 0494 +5°C f

F0230000 Fluocortolone pivalate 1 100 mg 1 1212 +5°C a

Y0000796 Fluorescein 1 120 mg 1 99.2% CœÐHŒœO— 2348 +5°C a

Y0000804 Fluorescein impurity C 1 0.01 mg 1 2-(2,4-dihydroxybenzoyl)benzoic acid 2348 +5°C a

Y0000454 Diacetylfluorescein 1 100 mg 1 99.6% Cœ÷HŒÿOŸ 1213 +5°C a

F0245000 Fluoresceine sodium - reference spectrum 1 n/a 1 1213 l

F0250000 Fluorouracil 2 40 mg 1 0611,0766 +5°C g

Y0000762 Fluorouracil impurity A 1 10 mg 1 pyrimidine-2,4,6(1H,3H,5H)-trione (barbituric acid) 0611 +5°C a

Y0000763 Fluorouracil impurity B 1 10 mg 1 dihydropyrimidine-2,4,5(3H)-trione (isobarbituric acid or 5-hydroxyuracil) 0611 +5°C g

Y0000764 Fluorouracil impurity C 1 10 mg 1 pyrimidine-2,4(1H,3H)-dione (uracil) 0611 +5°C a

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Y0000765 Fluorouracil impurity F 1 10 mg 1 2-ethoxy-5-fluoropyrimidin-4(1H)-one (2-ethoxy-5-fluorouracil) 0611 +5°C g

Y0000791 Fluorouracil impurity mixture 1 0.0002 mg 1 0611 Yes +5°C g

F0253000 Fluoxetine hydrochloride 4 250 mg 1 99.9% CŒŸHŒ„ClF–NO 1104 +5°C g

F0253020 Fluoxetine impurity B 5 10 mg 1 methyl(3-phenylpropyl)amine 1104 +5°C g

F0253030 Fluoxetine impurity C 4 5 mg 1 (¢£)-methyl-[3-phenyl-3-(3-trifluoromethylphenoxy)-propyl] amine ; Batch 3 is valid until 30 April 2012

1104 +5°C g

Y0000064 Flupentixol dihydrochloride 1 100 mg 1 43.6% of Z-isomer Cœ–HœŸClœF–NœOS 1693 +5°C a

Y0000067 Flupentixol impurity D 1 15 mg 1 2-[2-[4-[3-[(EZ)-2-(trifluoromethyl)-9H-thioxanthen-9-ylidene]propyl]piperazin-1-yl]ethoxy]ethanol

1693 +5°C a

Y0000078 Flupentixol impurity F 2 25 mg 1 80.9% Cœ–Hœ—F–NœOS; 2-[4-[(EZ)-3-[(9RS)-2-(trifluoromethyl)-9H- thioxanthen-9-yl] prop-2-enyl]piperazin-1-yl]ethanol

1693 +5°C a

F0260000 Fluphenazine decanoate 2 60 mg 1 1014,1015 +5°C g(b)

Y0000009 Fluphenazine enantate 2 100 mg 1 1014,1015 +5°C g

F0280000 Fluphenazine dihydrochloride 1 50 mg 1 0904,1014 +5°C g

Y0000708 Fluphenazine impurity mixture 1 0.07 mg 1 0904 Yes +5°C g

Y0000298 Fluphenazine octanoate 3 20 mg 1 1014,1015 +5°C g

Y0000299 Fluphenazine sulfoxide 1 10 mg 1 0904,1014,10

15

+5°C g

Y0000211 Flurazepam monohydrochloride - reference spectrum 1 n/a 1 0905 l

F0285200 Flurbiprofen 1 50 mg 1 1519 +5°C g

F0285202 Flurbiprofen impurity A 1 20 mg 1 (2RS)-2-(biphenyl-4-yl)propanoic acid 1519 +5°C g

Y0000236 Fluspirilene 1 20 mg 1 1723 +5°C a

Y0000375 Fluspirilene impurity C 1 10 mg 1 8-[4,4-bis(4-fluorophenyl)butyl]-3-(hydroxymethyl)-1-phenyl-1,3,8- triazaspiro[4.5]decan-4-one

1723 +5°C a

F0285600 Flutamide 1 50 mg 1 1423 +5°C g

F0285603 Flutamide impurity C 1 20 mg 1 N-[4-nitro-3-(trifluoromethyl)phenyl]propanamide 1423 +5°C g

Y0000284 Fluticasone propionate 3 100 mg 1 99.6% Cœ—H–ŒF–O—S 1750 Yes +5°C a

Y0000221 Fluticasone impurity D 2 20 mg 1 S-methyl 6a,9a-difluoro-11b-hydroxy-16a-methyl-3-oxo-17a- propionyloxy-androsta-1,4-diene-17ß-carbothioate(S-methyl derivative)

1750 +5°C a

F0290000 Flutrimazole 1 100 mg 1 1424 +5°C g

F0290010 Flutrimazole impurity B 1 60 mg 1 (RS)-(2-fluorophenyl)(4-fluorophenyl)phenylmethanol 1424 +5°C g

Y0001090 Fluvastatin sodium 1 110 mg 1 2333 +5°C a

Y0001082 Fluvastatin for system suitability 1 0.5 mg 1 2333 Yes +5°C a

Y0000854 Fluvoxamine maleate 1 5 mg 1 1977 +5°C g

Y0000853 Fluvoxamine for system suitability 1 1.004 mg 1 1977 Yes +5°C g

Y0000916 Fluvoxamine impurity D 1 10 mg 1 5-methoxy-1-[4-(trifluoromethyl)phenyl]pentan-1-one 1977 +5°C g

Y0000386 Foeniculin for peak identification 1 100 mg 1 Anise oil 0804 Yes +5°C a

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F0300000 Folic acid 8 300 mg 2 91.3 % CŒ„HŒ„NŸOÿ 0067 Yes +5°C a

Y0001242 Folic acid impurity A 1 15 mg 1 (2S)-2-[(4-aminobenzoyl)amino]pentanedioic acid (N-(4-aminobenzoyl)-l- glutamic acid)

0067 +5°C a

Y0001243 Folic acid impurity D 2 70 mg 1 4-[[(2-amino-4-oxo-1,4-dihydropteridin-6-yl)methyl]amino]benzoic acid(pteroic acid)

0067 Yes +5°C a

F0372000 Formoterol fumarate dihydrate 2 10 mg 1 1293,1724 +5°C g

Y0000339 Formoterol for impurity I identification 1 10 mg 1 1724 +5°C g

Y0000340 Formoterol fumarate for system suitability 1 10 mg 1 1724 Yes +5°C g

F0380000 Formylfolic acid 3 30 mg 1 91.4% CœÐHŒ„NŸOŸ; 10-Formylfolic acid 0978,1606 Yes -20°C c

F0389000 Foscarnet sodium hexahydrate 1 50 mg 1 1520 +5°C a

F0389004 Foscarnet impurity B 1 10 mg 1 disodium (ethoxyoxydophosphanyl)formate 1520 +5°C a

Y0001222 Foscarnet impurity D 1 50 mg 1 1520 +5°C a

Y0001213 Foscarnet impurity mixture 1 0.012 mg 1 1520 Yes +5°C a

Y0000782 Fosfomycin calcium 1 10 mg 1 1328 +5°C a

F0399950 Fosfomycin sodium - reference spectrum 1 n/a 1 1329 l

F0400000 Fosfomycin trometamol 2 1500 mg 1 99.7% CŸHŒ‡NOŸP 1425 Yes +5°C a

Y0001227 Fosinopril sodium 1 60 mg 1 1751 +5°C a

Y0001228 Fosinopril impurity A 1 5 mg 1 (2S,4S)-4-cyclohexyl-1-[[(R)-hydroxy(4-phenylbutyl)phosphoryl]acetyl]pyrrolidine-2-carboxylic acid

1751 +5°C a

Y0001229 Fosinopril impurity B 1 5 mg 1 (2RS,4RS)-4-cyclohexyl-1-[[(RS)-[(1SR)-2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphoryl]acetyl]pyrrolidine-2-carboxylic acid

1751 +5°C a

Y0001230 Fosinopril impurity C 1 10 mg 1 mixture of (2S,4S)-4-cyclohexyl-1-[[(S)-[(1S)-2-methyl-1-(1-oxopropoxy) propoxy](4-phenylbutyl)phosphoryl]acetyl]pyrrolidine-2-carboxylic acid and (2S,4S)-4-cyclohexyl-1-[[(R)-[(1R)-2-methyl-1-(1-oxopropoxy)propoxy](4- phenylbutyl)phosphoryl]acetyl]pyrrolidine-2-carboxylic acid

1751 +5°C a

Y0001231 Fosinopril impurity D 1 10 mg 1 (2S,4R)-4-cyclohexyl-1-[[(R)-[(1S)-2-methyl-1-(1-oxopropoxy)propoxy](4- phenylbutyl)phosphoryl]acetyl]pyrrolidine-2-carboxylic acid

1751 +5°C a

Y0001232 Fosinopril impurity I 1 5 mg 1 [(RS)-[(1SR)-2-methyl-1-(1-oxopropoxy)propoxy](4-phenylbutyl)phosphoryl]acetic acid

1751 +5°C a

Y0001233 Fosinopril impurity K 1 5 mg 1 (2S,4S)-4-cyclohexyl-1-(2,2-dimethyl-1-oxopropyl)pyrrolidine-2-carboxylic acid 1751 +5°C a

Y0001212 Fosinopril impurity mixture 1 0.02 mg 1 1751 Yes +5°C a

F0450000 Framycetin sulfate 5 25 mg 2 17640 IU per vial Cœ–H÷ÿNÿOŒ–,xHœSO÷ ; Batch 4 is valid until 30 April 2012 0180,0197,20

702

Yes -20°C a

F0550000 Fructose 1 100 mg 1 0177,0178,01

87,

0188,0204,02

09,

0924,1061,15

70

+5°C a

Y0001399 Fulvestrant 1 120 mg 1 98.8% C–œH÷ŸF—O–S 2443 Yes +5°C a

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Y0001413 Fulvestrant for system suitability 1 40 mg 1 2443 Yes +5°C a

F0600000 Fumaric acid 3 120 mg 1 Batch 2 is valid until 31 July 2012 0365,0902,11

90, 1592

+5°C a

F0700000 Furosemide 2 100 mg 1 Batch 1 is valid until 31 January 2013 0391,2185 +5°C a

Y0001493 Furosemide for peak identification 1 10 mg 1 0391 Yes +5°C a

F0702000 Furosemide impurity A 4 5 mg 1 2-chloro-4-(furfurylamino)-5-sulphamoylbenzoic acid 0391 +5°C a

Y0001411 Fusidic acid 1 10 mg 1 0798 -20°C c

F1000000 Fusidic acid - reference spectrum 1 n/a 1 0798,0848 l

Y0001394 Fusidic acid for peak identification 1 5 mg 1 0798,0848 Yes -20°C c

Y0001384 Fusidic acid impurity mixture 1 0.0475 mg 1 0798,0848 Yes -20°C c

Y0001280 Gabapentin 1 300 mg 1 99.9% C„HŒŸNOœ 2173 Yes +5°C a

Y0001281 Gabapentin impurity A 1 20 mg 1 2-azaspiro[4.5]decan-3-one 2173 +5°C a

Y0001348 Gabapentin impurity B 1 20 mg 1 (1-cyanocyclohexyl)acetic acid 2173 -20°C c

Y0001349 Gabapentin impurity D 1 10 mg 1 [1-[(3-oxo-2-azaspiro[4.5]dec-2-yl)methyl]cyclohexyl]acetic acid 2173 +5°C a

G0049000 Galactitol 2 50 mg 1 1381 +5°C a

G0050000 Galactose 2 60 mg 1 1215 +5°C a

Y0001279 Galantamine hydrobromide 1 10 mg 1 2366 +5°C g

Y0001190 Galantamine natural for system suitability 1 10 mg 1 2366 Yes +5°C g

Y0001201 Galantamine racemic mixture 1 10 mg 1 2366 +5°C g

Y0001191 Galantamine synthetic for system suitability 1 5 mg 1 2366 Yes +5°C g

G0100000 Gallamine triethiodide 1 100 mg 1 0181 +5°C a

G0150000 Gammacyclodextrin 2 60 mg 1 91,2% C÷‡H‡ÐOŒÐ ; Batch 1 is valid until 1 June 2013 1070,1487 Yes +5°C a

Y0001129 Ganciclovir 1 220 mg 1 1752 +5°C a

Y0001144 Ganciclovir impurity mixture 1 0.005 mg 1 1752 Yes +5°C a

Y0000675 Gemcitabine hydrochloride 1 50 mg 1 99.9% C„HŒœClFœN–O÷ 2306 +5°C g

Y0000676 Gemcitabine impurity A 1 20 mg 1 4-aminopyrimidin-2(1H)-one (cytosine) 2306 +5°C a

Y0000513 Gemfibrozil 1 5 mg 1 1694 +5°C g

Y0000514 Gemfibrozil for system suitability 1 0.196 mg 1 1694 Yes +5°C g

G0200000 Gentamicin sulfate 8 25 mg 2 16500 IU per vial ; Batch 7 is valid until 31 January 2013 0331,20702 Yes -20°C c

Y0001112 Gestodene 1 100 mg 1 99.4% CœŒHœÿOœ 1726 +5°C a

Y0001363 Gentamicin for peak identification 1 10 mg 1 0331 Yes -20°C c

Y0001110 Gestodene for system suitability 1 10 mg 1 1726 Yes +5°C a

Y0001116 Gestodene impurity I 1 0.01 mg 1 13-ethyl-17-hydroxy-5-methoxy-18,19-dinor-5alpha,17alpha-pregn-15-en-20- yn-3-one

1726 +5°C a

Y0001012 Ginkgo dry extract for peak identification 1 150 mg 1 1827 Yes -20°C c

Y0001010 Ginkgolic Acids 2 20 mg 1 0.37% of ginkgolic acid C17 ; Batch 1 is valid until 31 May 2012 1827 Yes -20°C c

Y0001029 Ginseng dry extract HRS 1 500 mg 1 2356 Yes -20°C c

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Y0001347 Ginsenoside Rb1 1 30 mg 1 88.1 % C—÷H„œOœ– 2356 Yes +5°C a

G0300000 Gitoxin 2 30 mg 1 0078,0079,21

68

+5°C g

G0325000 Glibenclamide 3 100 mg 1 0718 +5°C a

Y0001511 Glibenclamide for peak identification 1 30 mg 1 0718 Yes +5°C a

G0325010 Glibenclamide impurity A 3 10 mg 1 4-[2-(5-chloro-2-methoxybenzamido)ethyl]benzene- sulphonamide ; Batch 2 is valid until 31 December 2012

0718 +5°C a

Y0000242 Glibenclamide impurity B 2 20 mg 1 methyl [[4-[2-[(5-chloro-2-methoxybenzoyl)amino]ethyl]phenyl]sulphonyl]carbamate

0718 Yes +5°C a

G0326000 Gliclazide 2 20 mg 1 0718,1524 +5°C a

G0326004 Gliclazide impurity B 3 25 mg 1 2-nitroso-octahydrocyclopenta[c]pyrrole 1524 +5°C a

G0326012 Gliclazide impurity F 4 50 mg 1 1-(hexahydrocyclopenta[c]pyrrol-2(1H)-yl)-3-[(2-methylphenyl) sulphonyl]urea

1524 +5°C a

Y0000515 Glimepiride 1 60 mg 1 99.4% Cœ÷H–÷N÷O—S 2223 Yes +5°C a

Y0000516 Glimepiride for system suitability 3 0.012 mg 1 Batch 2 is valid until 31 January 2013 2223 +5°C a

G0340000 Glipizide 1 50 mg 1 0906 +5°C a

G0342000 Glipizide impurity A 1 10 mg 1 4-[2-(5-methylpyrazine-2-carboxamido)ethyl]benzene sulphonamide 0906 +5°C a

Y0000523 Glipizide impurity C 1 10 mg 1 ethyl [2-[4-[(cyclohexylcarbamoyl)sulphamoyl]phenyl]ethyl] carbamate 0906 +5°C a

Y0000643 Glipizide impurity D 1 10 mg 1 6-methyl-N-[2-(4-sulphamoylphenyl)ethyl]pyrazine-2-carboxamide 0906 +5°C a

Y0001140 Glipizide impurity mixture 1 0.002 mg 1 0906 Yes +5°C a

Y0001406 Glucosamine hydrochloride 1 10 mg 1 2446 +5°C a

Y0000191 Human glucagon 2 2.94 mg 2 2.94 mg pure human glucagon per vial CŒ—–Hœœ—N÷–O÷„S ; Batch 1 is valid until30 April 2012

1635 Yes -20°C c

Y0001381 Glucosamine for system suitability 1 40 mg 1 2446,2447 +5°C a

Y0001407 Glucosamine sulfate sodium chloride 1 15 mg 1 2447 +5°C a

G0350500 Glucose 2 100 mg 1 Batch 1 is valid until 30 April 2012 0177,0178,01

87,

0188,0204,02

09,

1061,1215,15

70

+5°C a

G0355000 Glutamic acid 2 50 mg 1 0750,0797,14

45, 2076

+5°C a

Y0000517 Glutathione 1 10 mg 1 1670 +5°C a

G0360000 Glutethimide - * psy 1 50 mg 1 1291 +5°C j

Y0001391 Glycerol formal 1 20 mg 2 1671 +5°C a

Y0000794 Glycerol monocaprylate 1 500 mg 1 2213 Yes +5°C g

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Y0000795 Glycerol monocaprylocaprate 1 500 mg 1 In the chromatogram supplied within the leaflet (Rev 02) of the current CRS batch 1, some peaks have been mislabelled, the correct version of the leaflet (Rev 03) is now available on the website. The quality of the product itself is not questioned and can still to be used.

2392 Yes +5°C g

G0400006 Glycerol monolinoleate 1 2000 mg 1 1429 +5°C a

G0400007 Glycerol mono-oleate 2 2500 mg 1 Batch 1 is valid until 1 April 2013 1430 +5°C a

G0400008 Glycerol monostearate 40-55 3 2000 mg 1 0495 +5°C a

G0400101 Glyceryl trinitrate - reference spectrum 1 n/a 1 1331 l

G0400100 Glyceryl trinitrate solution 2 0.5 ml 1 1% m/m in ethanol C–H—N–O„ 1331,1355 +5°C f

G0450000 Glycine 3 50 mg 1 0614,0752 +5°C a

Y0001308 Glycopyrronium bromide 1 10 mg 1 1783 +5°C a

Y0001309 Glycopyrronium for peak identification 1 10 mg 1 1783 Yes +5°C a

Y0001358 Glycopyrronium impurity N 1 10 mg 1 94.0% CŒ„Hœ„NO–+; (3RS)-3-[(2RS)-(2-cyclopentyl-2-hydroxy-2-phenylacetyl)oxy]-1,1-dimethylpyrrolidinium

1783 Yes +5°C a

Y0000433 Ammonium glycyrrhizate 1 70 mg 1 1772 +5°C a

G0460000 Glycyrrhizate (monoammonium) 3 300 mg 1 78.6% C÷œHÿ—NOŒÿ 0277,1536,

2378

Yes +5°C a

G0525000 Gonadorelin 5 5 mg 1 4.96 mg per vial of C——HŸ—NŒŸOŒ– 0827 Yes -20°C c

Y0000125 Goserelin 2 2 mg 1 1.87 mg per vial of C—„H‡÷NŒ‡OŒ÷ 1636 -20°C c

Y0000126 Gosereline - reference spectrum 1 n/a 1 1636 l

Y0000019 4-D-Ser-goserelin 1 0.1 mg 1 1636 -20°C c

Y0000194 Goserelin validation mixture 1 1 mg 1 Supplied with the Ph. Eur. reference chromatogram 1636 Yes -20°C c

Y0001473 Goserelin for NMR identification 1 14 mg 1 replace Y0000126 1636 -20°C c

G0550000 Gramicidin 1 250 mg 1 1081 IU per mg 0907,1662,20

702

Yes +5°C a

Y0000396 Granisetron hydrochloride 1 120 mg 1 99.8% CŒ‡Hœ—ClN÷O 1695 +5°C a

Y0000477 Granisetron impurity A 2 1 mg 1 2-methyl-N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-2H- indazole-3-carboxamide

1695 +5°C a

Y0000478 Granisetron impurity B 2 1 mg 1 N-[(1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]non-3-yl]-1H-indazole-3- carboxamide 1695 Yes +5°C a

Y0000395 Granisetron impurity E 3 15 mg 2 (1R,3r,5S)-9-methyl-9-azabicyclo[3.3.1]nonan-3-amine 1695 +5°C a

G0600000 Griseofulvin 2 50 mg 1 0182 +5°C a

Y0000619 Guaiacol 1 2200 mg 1 99.5% CŸH‡Oœ 1978 +5°C a

G0700000 Guaifenesin 1 100 mg 1 0615 Yes +5°C a

Y0000117 Halofantrine hydrochloride 1 125 mg 1 99.6% CœÿH–ŒCl–F–NO 1979 +5°C g

Y0000118 Halofantrine impurity C 1 10 mg 1 [1,3-dichloro-6-(trifluoromethyl)phenantren-9-yl]methanol 1979 +5°C g

New H0100000 Haloperidol 2 60 mg 1 Batch 1 is valid until 1 July 2013 0616,0995,11

78, 1503

+5°C g

H0100100 Haloperidol decanoate 1 60 mg 1 1397,1431 +5°C a

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Y0001518 Haloperidol for peak identification 1 25 mg 1 0616 Yes +5°C g

Y0001517 Haloperidol for system suitability 1 25 mg 1 0616 Yes +5°C g

H0150000 Halothane - reference spectrum 1 n/a 1 0393 l

Y0000673 Harpagoside 1 1.03 mg 1 1.01mg per vial Cœ÷H–ÐOŒŒ 1095, 1871 +5°C a

H0185000 Heparin Low-Molecular-Mass for assay BRP 7 1 mg 5 Anti-IIa activity : 31 IU per vial; Anti-Xa activity : 104 IU per vial ; Batch 6 is valid until 30 April 2012

0828 Yes +5°C b

H0190000 Heparin Low-Molecular-Mass for calibration CRS 2 25 mg 1 Mna = 3800 0828 Yes +5°C a

H0200000 Heparin sodium BRP 3 2 ml 1 1010 IU per ml 0569, 20705 Yes +5°C a

Y0001287 Heparin calcium for NMR identification 1 30 mg 1 0332 Yes +5°C a

Y0001283 Heparin sodium for NMR identification 1 30 mg 1 0333 Yes +5°C a

Y0001282 Heparin for physico-chemical analysis 1 300 mg 1 0333 +5°C a

H0205010 Hepatitis A vaccine (inactivated, adsorbed) Type B BRP 2 0.5 ml 3 262 IU per ml; Please contact us for information on the type needed for your use See leaflet,

20714

Yes +5°C b

Y0001192 Hepatitis A Vaccine (Inactivated, Non-Adsorbed) BRP 1 0.8 ml 3 To be stored below -50°C 20714,1526,1

935, 1107

Yes -80°C d

Y0000389 Hepatitis B vaccine (rDNA) BRP method A (thiomersal free) 2 0.5 ml 2 16.6 micrograms per ml See leaflet,

20715

Yes +5°C b

H0210010 Hepatitis B vaccine (rDNA) BRP method B 2 1 ml 2 20 micrograms per ml See leaflet,

1056

Yes +5°C b

H0220000 Heptadecanol 3 600 mg 2 97.9% CŒŸH–ÿO 0801,0802,08

47

+5°C a

Y0000063 Heptaminol hydrochloride 1 150 mg 1 1980 +5°C a

Y0000057 Heptaminol impurity A 2 20 mg 1 93.4% C‡HŒŸN; (2RS)-6-methylhept-5-en-2-amine 1980 +5°C a

H0250000 alpha-Hexachlorocyclohexane 3 10 mg 1 0772 +5°C g

H0330000 Hexamidine diisetionate 2 20 mg 1 Batch 1 is valid until 31 January 2013 1436 +5°C g

H0325000 Hexetidine 2 100 mg 1 1221 +5°C a

H0400000 Hexobarbital 1 500 mg 1 0183 +5°C a

H0420000 Hexylresorcinol 1 100 mg 1 1437 +5°C a

H0500000 Hide powder 4 500 mg 1 20814 +5°C a

H0600000 Histamine dihydrochloride 2 250 mg 1 Batch 1 is valid until 31 December 2012 0143 +5°C a

H0750000 Histidine 2 100 mg 1 0911 +5°C a

H0755000 Histidine hydrochloride monohydrate 1 100 mg 1 0910 +5°C a

H0800000 Homatropine hydrobromide 1 100 mg 1 0500,0720 +5°C a

H0830000 Homatropine methylbromide 1 25 mg 1 0720 +5°C a

Y0001383 Homatropine methylbromide for system suitability 1 5 mg 1 0720 Yes +5°C a

H0837000 L-Homocysteine thiolactone hydrochloride - reference spectrum 1 n/a 1 1617 l

Y0001290 Honokiol 1 20 mg 1 99.6% CŒ‡HŒ‡Oœ 2567 Yes -20°C g(c)

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H0900000 Human albumin for electrophoresis BRP 2 1 ml 1 96,7% to 99,2% of the total protein is the main band (albumin), protein content : 5%

0255 Yes -20°C c

Y0000219 Human anti-D immunoglobulin BRP 1 40 mg 1 285 IU anti-D immunoglobulin per ampoule1uc=40 mg

See leaflet,

20713

Yes -20°C c

Y0000667 Human coagulation factor VII concentrate BRP 2 25 mg 2 9.9 IU per vial See leaflet,

20710

Yes -20°C c

H0920000 Human coagulation factor VIII concentrate BRP 4 37 mg 5 10.4 IU per vial See leaflet,

20704

Yes -20°C c

H0920500 Human coagulation factor IX concentrate BRP 2 30 mg 5 7.9 IU/vial; Common standard with FDA and WHO (4th IS) See leaflet,

20711

Yes -20°C a

H0950000 Human hepatitis A immunoglobulin BRP 1 10 mg 3 10.2 IU per vial See leaflet,

0338, 0769

Yes -20°C c

Y0001504 Human immunoglobulin BRP (ACA and Molecular size) 1 1 uc 1 See leaflet,

0338, 0918

Yes +5°C a

Y0001512 Human Immunoglobulin BRP (Fc Function and Molecular size) 1 9000 mg 1 See leaflet,

0338, 0918

Yes +5°C a

H1000000 Human immunoglobulin for electrophoresis BRP 2 96 mg 1 75.7% to 80.9% of the total protein is the main band (Ig), protein content: 5% 0338,0918 Yes +5°C a

Y0000488 Human immunoglobulin (molecular size) BRP 1 700 mg 3 Each vial contains 0.7 gram of immunoglobulin G See leaflet,

0338,

0918,1928

Yes +5°C a

H1005000 Human Plasma Pools for NAT validation 1 3502 mg 1 Set of 103 plasma pool samples See leaflet,

20621

Yes -20°C c

H1100000 Human rabies immunoglobulin BRP 1 170 mg 3 91 IU per vial See leaflet,

0723

Yes -20°C c

H1110000 Human tetanus immunoglobulin BRP 1 87 mg 1 120 IU per vial 0398 Yes -20°C c

Y0000502 Human vaccinia immunoglobulin 1 1 ml 3 23 IU per vial See leaflet Yes -20°C b

H1115000 Hyaluronidase BRP 1 50 mg 1 328 IU per mg 0912 Yes +5°C a

H1120000 Hydralazine hydrochloride 1 20 mg 1 0829 +5°C g

Y0001151 Hydrastine hydrochloride 1 20 mg 1 91,7% CœŒHœœClNOÿ 1831,2500 Yes -20°C c

New H1200000 Hydrochlorothiazide 7 300 mg 1 99.8% CŸH‡ClN–O÷Sœ ; Batch 6 is valid until 31 August 2013 0394 Yes +5°C a

Y0001494 Hydrochlorothiazide for peak identification 1 10 mg 1 0394 Yes +5°C a

Y0000646 Hydrocodone hydrogen tartrate 2.5-hydrate - * narc 1 10 mg 1 1784 +5°C k

Y0000710 Hydrocodone for peak identification - * narc 1 10 mg 1 1784 Yes +5°C k

H1300000 Hydrocortisone 8 100 mg 1 0335,0353,05

61

+5°C a

Y0001092 Hydrocortisone for peak identification 2 5 mg 1 Batch 1 is valid until 31 December 2012 0335 Yes +5°C a

H1400000 Hydrocortisone acetate 9 125 mg 1 99% Cœ–H–œOÿ; Hydrocortisone acetate CRS 8 is suitable for monographs01/2011:0335, 01/2008:334, 01/2008:0321, 01/2008:0767 and 01/2008:0734 only. ; Batch 8 is valid until 30 September 2012

0321,0334,07

34, 0767

Yes +5°C a

Y0001482 Hydrocortisone acetate for peak identification 1 15 mg 1 0334 Yes +5°C a

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Code


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H1425000 Hydrocortisone hydrogen succinate 2 100 mg 1 0768,1131 -20°C a

H1426000 Hydrogenated wool fat 1 250 mg 1 0969 +5°C a

Y0000446 Hydromorphone hydrochloride - * narc 1 10 mg 1 2099 +5°C k

B0650000 Hydrous benzoyl peroxide - reference spectrum 1 n/a 1 0704 l

H1428000 Hydroxocobalamin 1 10 mg 1 0913,0914,09

15

+5°C a

Y0000119 Hydroxycarbamide 1 175 mg 1 99.9% CH÷NœOœ 1616 +5°C a

H1429400 Hydroxyethyl salicylate 1 125 mg 1 1225 +5°C a

H1429700 4-Hydroxyphenoxymethylpenicillin potassium 3 20 mg 1 98.4% CŒÿHŒŸKNœOÿS 0148,0149 Yes -20°C a

H1430000 D-alpha-(4-Hydroxy-phenyl)glycine 1 50 mg 1 (2R)-2-amino-2-(4-hydroxyphenyl)acetic acid - Cefadroxyl impurity A 0813 +5°C a

Y0001277 Hydroxyethyl starch (medium MW) 1 1200 mg 1 Average Mw 130100 Da 1785 Yes +5°C a

Y0001322 Hydroxyethyl starch (high Mw) 1 800 mg 1 507900 Da 1785 Yes +5°C a

New Y0000186 Hydroxypropylbetadex 2 200 mg 1 Batch 1 is valid until 30 June 2013 1804 Yes +5°C a

H1435000 Hydroxyzine hydrochloride 3 600 mg 1 0916,1086,10

92

+5°C g

Y0000011 Hymecromone 1 100 mg 1 1786 +5°C a

Y0000012 Hymecromone impurity A 1 25 mg 1 Resorcinol 1786 +5°C g

Y0000013 Hymecromone impurity B 2 25 mg 1 7-hydroxy-2-methyl-4H-1-benzopyran-4-one. 1786 +5°C a

Y0000483 Hyoscine 1 10 mg 1 2167 +5°C g

Y0000484 Hyoscine impurity A 1 10 mg 1 (1R,2R,4S,5S,7s)-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl(2S)-3-hydroxy-2-phenylpropanoate (norhyoscine)

2167 +5°C g

H1450000 Hyoscine butylbromide 2 20 mg 1 0737 +5°C a

Y0000447 Hyoscine butylbromide impurity E 1 10 mg 1 (1R,2R,4S,5S,7S)-9-butyl -7-[[(2S)-3-hydroxy-2-phenylpropanoyl]oxy]-3-oxa -9-azoni atricyclo[3.3.1.02,4]nonane

0737 +5°C a

H1500000 Hyoscine hydrobromide 1 50 mg 1 0106,0500 +5°C a

Y0000448 Hyoscine hydrobromide impurity B 1 10 mg 1 (1R,2R,4S,5S,7s)-3-oxa-9-azatricyclo[3.3.1.02,4]non-7-yl(2S)-3-hydroxy-2-phenylpropanoate

0106 +5°C a

H1600000 Hyoscyamine sulfate 1 100 mg 1 0501 +5°C g

Y0000449 Hyoscyamine impurity E 1 10 mg 1 (1R,3r,5S)-8-azabicyclo[3.2.1]oct-3-yl(2S)-3-hydroxy-2-phenyl-propanoate

0501 +5°C g

Y0000915 Hypromellose phthalate 1 10 mg 1 347 +5°C a

I0020000 Ibuprofen 5 250 mg 1 Batch 4 is valid until 31 May 2012 0721 +5°C a

New B1220000 Ibuprofen impurity B 7 1.1 mL 1 solution of 0.06% m/V in acetonitrile - to be diluted as appropriate.; (2RS)-2- (4-Butylphenyl)propanoic acid ; Batch 6 is valid until 31 August 2013

0721 +5°C g

Y0000140 Ibuprofen impurity F 2 5 mg 1 3-[4-(2-methylpropyl)phenyl]propanoic acid 0721 +5°C a

Y0000881 Ibuprofen for peak identification 4 0.09 mg 1 Batch 3 is valid until 31 August 2012 0721 Yes +5°C a

I0050000 Idoxuridine 1 50 mg 1 0669 +5°C a

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I0060000 Ifosfamide 1 50 mg 1 100.0% CŸHŒ—ClœNœOœP 1529 +5°C g

I0060100 Ifosfamide - reference spectrum 1 n/a 1 1529 l

I0060002 Ifosfamide impurity A 3 100 mg 2 3-[(2-chloroethyl)amino]propyl dihydrogen phosphate ; Batch 2 is valid until30 April 2012

1529 -20°C g(c)

I0060004 Ifosfamide impurity B 1 20 mg 1 bis[3-[(2-chloroethyl)amino]propyl] dihydrogen diphosphate 1529 +5°C g

I0060010 Ifosfamide impurity E 1 10 mg 2 3-chloro-N-(2-chloroethyl)propan-1-amine 1529 +5°C g

I0060012 Ifosfamide impurity F 2 10 mg 1 (RS)-2-chloro-3-(2-chloroethyl)-1,3,2-oxazaphosphinane 2-oxide 1529 +5°C b

I0086000 Imidazole 1 100 mg 1 0757,1424,

2270

+5°C g

I0090000 Imipenem 2 100 mg 1 92.9% CŒœHŒŸN–O÷S 1226 -20°C c

I0100000 Imipramine hydrochloride 2 50 mg 1 0029,0408,08

17,

+5°C g

Y0000893 Imipramine for system suitability 1 10 mg 1 0029 +5°C g

Y0001153 Immunoglobulin for anti-A, anti-B antibodies limit test BR 1 45 mg 1 20620 Yes -20°C c

Y0001152 Immunoglobulin panel for anti-A, anti-B antibodies test 1 96 mg 1 20620 Yes -20°C c

Y0000540 Immunoglobulin panel for anti-D antibodies test BRP 1 2000 mg 1 See leaflet,

20626

Yes -20°C a

Y0001205 Imperatorin 1 20 mg 1 98.8 % CŒÿHŒ÷O÷ 2556 Yes +5°C a

I0150000 Indapamide 5 150 mg 1 97.6% CŒÿHŒÿClN–O–S ; Batch 4 is valid until 31 October 2012 1108 Yes +5°C a

I0150020 Indapamide impurity B 3 5 mg 1 4-chloro-N-(2-methyl-1H-indol-1-yl]-3-sulphamoylbenzamide 1108 +5°C a

Y0000788 Indinavir 1 100 mg 1 97.2% C–„H÷„N—O— 2214 +5°C a

Y0000880 Indinavir sulfate - reference spectrum 1 n/a 1 2214 l

Y0000746 Indinavir for system suitability 1 20 mg 1 2214 Yes +5°C a

I0200000 Indometacin 2 50 mg 1 0092,0922,16

86

+5°C g

Y0000349 Insulin aspart 2 8 mg 1 7.45 mg of insulin aspart + B28iso insulin aspart + A21Asp insulin aspart + B3Asp insulin8 aspart + B3iso Asp insulin aspart per vial ; Batch 1 is valid until 30 April

2084 Yes -20°C c

I0305000 Insulin (bovine) 3 7.99 mg 1 7.99 mg insulin + A21 desamido per vial Cœ—÷H–ŸŸNÿ—OŸ—Sÿ 0854,1637 Yes -20°C c

I0310000 Insulin (human) 4 8 mg 1 6.94 mg insulin + A21 desamido per vial Cœ—ŸH–‡–Nÿ—OŸŸSÿ 0838,0854,16

37, 1638

Yes -20°C c

Y0000348 Insulin lispro 2 5.75 mg 1 5.93 mg insulin lispro per vial ; Batch 1 is valid until 1 June 2013 2085 Yes -20°C c

I0320000 Insulin (porcine) 3 8.61 mg 1 8.61 mg insulin + A21-desamido per vialsee recommandations for use on accompagnying leaflet Cœ—ÿH–‡ŒNÿ—OŸÿSÿ

0838,0854,16

37, 1638

Yes -20°C c

I0320300 Interferon alfa-2a 3 1 ml 1 About 1.52 mg per mL 1110 Yes -80°C d

I0320301 Interferon alfa-2b 5 200 µL 1 About 9.74 mg per mL 1110 Yes -80°C d

Y0001101 Interferon beta-1a 2 0.5 mL 1 335 µg of interferon beta-1a per mL C„Ð‡HŒ÷ÐÿNœ÷ÿOœ—œSŸ ; Batch 1 is valid until30 November 2012

1639 Yes -80°C d

I0320330 Interferon gamma 1b 2 0.5 mL 2 about 1 mg per ml 1440 Yes -80°C d

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Code


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I0320331 Interferon gamma-1b validation solution 2 0.2 ml 1 about 1 mg per ml 1440 -80°C d

I0328000 Iobenguane sulfate 2 25 mg 1 97.2% CŒÿHœœIœNÿO÷S 1111,1112,111

3,2351

+5°C b

Y0000839 Iobenguane sulfate - reference spectrum 1 n/a 1 2351 l

Y0001294 Iodixanol 1 60 mg 1 2215 +5°C a

Y0001292 Iodixanol impurity C 1 10 mg 1 5-[acetyl[3-[[3,5-bis[(2,3-dihydroxypropyl)carbamoyl]-2,4,6-triiodophenyl] amino]-2-hydroxypropyl]amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6- triiodobenzene-1,3-dicarboxamide

2215 +5°C a

Y0001291 Iodixanol impurity E 1 10 mg 1 5-[acetyl[3-[acetyl[3-carbamoyl-5-[(2,3-dihydroxypropyl)carbamoyl]-2,4,6- triiodophenyl]amino]-2-hydroxypropyl]amino]-N,N'-bis(2,3- dihydroxypropyl)-2,4,6-triiodobenzene-1,3-dicarboxamide

2215 +5°C a

Y0001293 Iodixanol impurity H 1 10 mg 1 5-[acetyl[3-[acetyl[3-[[3-[3-[acetyl[3,5-bis[(2,3-dihydroxypropyl)carbamoyl]-2,4,6-triiodophenyl]amino]-2-hydroxypropoxy]-2-hydroxypropyl]carbamoyl]-5-[(2,3-dihydroxypropyl)carbamoyl]-2,4,6-triiodophenyl] amino]-2-hydroxypropyl]amino]-N,N'-bis(2,3-dihydroxypropyl)-2,4,6- triiodobenzene-1,3-dicarboxamide

2215 +5°C a

I0320800 Iohexol 1 150 mg 1 1114 +5°C a

I0320810 Iohexol impurity A 1 50 mg 1 5-acetamido-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-tri-iodo benzene-1,3- dicarboxamide

1114 +5°C a

I0320820 Iohexol impurity J 1 125 mg 1 5-amino-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-tri-iodobenzene-1,3- dicarboxamide 1114,2215 +5°C a

Y0000672 Iohexol for peak identification 1 10 mg 1 1114 Yes +5°C a

I0329000 Iopamidol 1 50 mg 1 1115 +5°C a

I0329010 Iopamidol impurity A 1 10 mg 1 N,N'-bis[2-hydroxy-1-(hydroxymethyl)ethyl]-5-amino-2,4,6-tri- iodoisophthalamide

1115, 1754 +5°C a

Y0000406 Iopamidol impurity H 1 10 mg 1 4-chloro-N,N'-bis(2-hydroxy-1-(hydroxymethyl)ethyl)-5-(2- hydroxypropanoyl)amino)2,6-diiodobenzenz-1,3-dicarboxamide

1115 +5°C a

I0330000 Iopanoic acid 1 100 mg 1 0700 +5°C a

Y0001297 Iopentol 1 10 mg 1 2215 +5°C b

Y0001020 Iopromide 1 100 mg 1 98.7% CŒ‡Hœ÷I–N–O‡ 1753 Yes +5°C a

Y0001077 Iopromide impurity A 1 0.125 mg 1 5-amino-N,N'-bis(2,3-dihydroxypropyl)-2,4,6-triiodo-N-methylbenzene-1,3- dicarboxamide

1753 +5°C a

Y0001021 Iopromide for system suitability 1 1 5 mg 1 1753 +5°C a

Y0001022 Iopromide for system suitability 2 1 5 mg 1 1753 +5°C a

I0340000 Iotalamic acid 1 150 mg 1 0751 +5°C a

A0560000 Iotalamic acid impurity A 1 20 mg 1 5-Amino-2,4,6-tri-iodo-N-methylisophthalamic acid 0751 +5°C a

Y0000555 Iotrolan 1 100 mg 1 1754 Yes +5°C a

Y0000658 Iotrolan for system suitability 1 5 mg 1 1754 +5°C a

Y0000141 Ioxaglic acid 2 125 mg 1 2009 Yes +5°C a

Y0000142 Ioxaglic acid impurity A 1 20 mg 1 3-amino-5-[(2-hydroxyethyl)carbamoyl]-2,4,6-triiodobenzoic acid 2009 +5°C a

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I0360000 Ipratropium bromide 5 120 mg 1 0919 +5°C a

Y0000276 Ipratropium impurity A 1 10 mg 1 (1R,3r,5S,8r)-3-hydroxy-8-methyl-8-(1-methylethyl)-8-azoniabicyclo[3.2.1]octane

0772 +5°C a

I0361000 Ipratropium bromide impurity B 3 10 mg 1 (1R,3r,5S,8s)-3-[[(2RS)-3-hydroxy-2-phenylpropanoyl]oxy]-8-methyl-8-(1- methylethyl)-8-azoniabicyclo[3.2.1]octane

0919 +5°C a

Y0001166 Irbesartan 1 60 mg 1 2465 +5°C a

Y0001156 Irbesartan impurity A 1 10 mg 1 1-(pentylamino)-N-[[2'-(1H-tetrazol-5-yl)biphenyl-4-yl]methyl]cyclopentanecarboxamide

2465 +5°C a

I0375000 Isoconazole 1 200 mg 1 1018 +5°C a

I0380000 Isoconazole nitrate 1 200 mg 1 1017 +5°C a

I0400000 Isoemetine hydrobromide 1 25 mg 1 0080,0081 +5°C f

Y0000858 Isoflurane 1 1.5 ml 1 1666 +5°C b

Y0000037 Isoflurane - reference spectrum 1 n/a 1 1673 l

I0460000 Isoleucine 1 50 mg 1 0770 +5°C a

I0465000 Isomalt 5 3000 mg 1 97.0 % CŒœHœ÷OŒŒ ; Batch 3 is valid until 31 July 2012Batch 4 is valid until 1 May 2013

1531 Yes +5°C a

Y0000070 Isomaltooligosaccharide 1 0.9 mg 1 1506 +5°C a

I0500000 Isoniazid 1 100 mg 1 0146 +5°C a

I0599990 Isoprenaline hydrochloride 1 50 mg 1 1332 +5°C a

I0600000 Isoprenaline sulfate 2 500 mg 1 0502 +5°C a

I0725000 Isopropyl hexadecanoate 2 100 mg 1 94.3% CŒ„H–‡Oœ 0839 +5°C a

I0750000 Isopropyl tetradecanoate 4 2 ml 1 97.9% CŒŸH–÷Oœ 0725 Yes +5°C a

New Y0001568 Isoquercitroside n/a 15 mg 1 97% CœŒHœÐOŒœ 2528,2667 Yes +5°C a

I0775000 Isosorbide dinitrate 3 350 mg 1 40,8% CÿH‡NœO‡ ; Batch 2 is valid until 1 June 2013 1117,1118 Yes +5°C f

I0775010 Isosorbide mononitrate 4 150 mg 1 99.9% CÿH„NOÿ; Isosorbide-5-nitrate ; Batch 3 is valid until 31 January 2013 1117,1118 Yes +5°C h

I0775020 Isosorbide-2-nitrate 3 50 mg 1 1117,1118 +5°C g

I0800000 Isotretinoin 4 60 mg 1 0693,1019 +5°C g(b)

Y0001218 Isotretinoin for peak identification 1 10 mg 1 1019 Yes +5°C g(b)

I0900000 Isoxsuprine hydrochloride 1 50 mg 1 1119 +5°C a

Y0000366 Isradipine 1 125 mg 1 99.2% CŒ„HœŒN–O— 2110 Yes +5°C g

Y0000367 Isradipine impurity D 1 5 mg 1 methyl 1-methylethyl 4-(2,1,3-benzoxadiazol-4-yl)-2,6-dimethylpyridine-3,5-dicarboxylate

2110 +5°C g

I7000000 Itraconazole 2 150 mg 1 1335 +5°C a

New Y0001100 Itraconazole for system suitability 2 25 mg 1 Batch 1 is valid until 30 September 2013 1335 Yes +5°C a

I8000010 Ivermectin 2 150 mg 1 90.6% of C48H74O14 (component H2B1a) ; Batch 1 is valid until 30 April 201 1336 Yes +5°C f

Y0000575 Ivy leaf standardised tincture 1 2 ml 1 0.20% (m/m) of hederacoside C; Ivy leaf standardised tincture CRS has been renamed as ivy leaf tincture HRS in 01/2013:2148.

2148 -20°C g(c)

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Y0000041 Josamycin 2 150 mg 1 1000 Ph. Eur. units per mg 1982,1983,20

702

Yes -20°C c

Y0000042 Josamycin propionate 2 150 mg 1 975 Ph. Eur. units per mg 1982,1983,20

702

+5°C a

Y0001315 Josamycin for peak identification 1 25 mg 1 1983 Yes +5°C a

K0100000 Kanamycin B sulfate 3 20 mg 1 0032,0033,06

45

+5°C a

K0200000 Kanamycin monosulfate 2 150 mg 1 799 IU per mg of CŒ‡H–‡N÷OŒ—S,HœO 0032,0033,00

53,

0485,0645,12

89,

Yes +5°C a

Y0000450 Ketamine hydrochloride - * narc 1 10 mg 1 1020 +5°C k

K0551000 Ketamine impurity A 2 50 mg 1 1-[(2-chlorophenyl)(methylimino)methyl]cyclopentanol 1020,1742 +5°C a

Y0000246 Ketobemidone hydrochloride - reference spectrum 1 n/a 1 1746 l

Y0000244 Ketobemidone impurity B 1 5 mg 1 1-[4-(3-hydroxyphenyl)-1-methylpiperidin-4-yl]ethanone 1746 +5°C g

Y0000245 Ketobemidone impurity C 1 5 mg 1 1-[4-(3-hydroxyphenyl)piperidin-4-yl]propan-1-one 1746 +5°C g

K0600000 Ketoconazole 2 150 mg 1 0921,1067,12

70

+5°C g

K1000000 3-Ketofusidic acid 3 10 mg 1 0798,0848 +5°C a

K2000000 Ketoprofen 2 50 mg 1 0922,1157,12

09

+5°C g

K2000010 Ketoprofen impurity A 4 10 mg 1 1-(3-benzoylphenyl)ethanone 0922 +5°C g

K2000015 Ketoprofen impurity C 3 15 mg 1 3-[(1RS)-1-carboxyethyl]benzoic acid 0922 +5°C g

Y0000486 Ketorolac trometamol 1 10 mg 1 1755 +5°C g

Y0000626 Ketorolac trometamol for peak identification 2 5 mg 1 Batch 1 is valid until 31 December 2012 1755 Yes +5°C g

Y0000164 Ketotifen hydrogen fumarate - reference spectrum 1 n/a 1 1592 l

New Y0000161 Ketotifen impurity G 4 0.0225 mg 1 4-(1-methylpiperidin-4-ylidene)-4H-benzo(4,5)cyclohepta(1,2-b)thiophen-9,10-dione ; Batch 3 is valid until 31 August 2013

1592 Yes +5°C g

Y0001200 Kudzuvine root dry extract 1 200 mg 1 2434,2483 Yes -20°C c

L0050000 Labetalol hydrochloride 2 120 mg 1 99.6 % CŒ„Hœ—ClNœO– ; Batch 1 is valid until 31 March 2013 0923 Yes +5°C g

Y0001548 Labetalol impurity A 1 10 mg 1 2-hydroxy-5-[1-hydroxy-2-[(1-methyl-3-phenylpropyl)-amino]ethyl]benzoic acid 0923 +5°C g

L0129000 Lactitol monohydrate 2 60 mg 1 93.8% CŒœHœ÷OŒŒ 1337 +5°C a

Y0000257 Lactobionic acid 1 100 mg 1 1647 +5°C g

A1206000 Lactose (anhydrous) 1 100 mg 1 1061 +5°C a

L0100000 Lactose 2 100 mg 1 0177,0178,01

87,

0188,0204,02

09,

+5°C a

L0130000 Lactulose 3 3000 mg 1 99.7% CŒœHœœOŒŒ 0924,1230 +5°C a

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Y0001510 Lactulose for peak identification 1 2600 mg 1 0924 Yes +5°C a

Y0000188 Lactulose for system suitability 3 12 mg 1 0924,1230 Yes +5°C a

Y0000425 Lamivudine 1 150 mg 1 99.7% C‡HŒŒN–O–S 2217 +5°C a

Y0000518 Lamivudine for system suitability 1 1 10 mg 1 2217 +5°C a

Y0000426 Lamivudine for system suitability 2 2 10.3 mg 1 2217 +5°C a

Y0001030 Lamotrigine 1 10 mg 1 1756 +5°C g

Y0001031 Lamotrigine for peak identification 1 20 mg 1 1756 Yes +5°C g

Y0001085 Lamotrigine for system suitability 1 10 mg 1 1756 Yes +5°C g

Y0001032 Lamotrigine impurity E 1 15 mg 1 2,3-dichlorobenzoic acid 1756 +5°C a

Y0000773 Lansoprazole 1 60 mg 1 2219 +5°C a

Y0000774 Lansoprazole for peak identification 1 1 mg 1 2219 Yes +5°C a

Y0001474 Lauric acid 1 1500 mg 1 97.9% 1848 Yes +5°C a

Y0000654 Leflunomide 1 100 mg 1 100,0% CŒœH„F–NœOœ 2330 +5°C g

Y0000487 Leflunomide impurity A 2 25 mg 1 4-(trifluoromethyl)aniline 2330 +5°C g

Y0000674 Leflunomide for peak identification 1 1 mg 1 2330 Yes +5°C g

Y0000685 Letrozole 1 70 mg 1 99.7% CŒŸHŒŒN— 2334 Yes +5°C a

L0375000 Leucine 2 50 mg 1 0771,0874 +5°C a

L0376000 Leuprorelin 5 1 mg 1 0.99 mg per vial of pure leuprorelin peptide C—„H‡÷NŒÿOŒœ 1442 -20°C c

L0376001 Leuprorelin - reference spectrum 1 n/a 1 1442 l

Y0000047 Levamisole hydrochloride for system suitability 3 60 mg 1 0726,1728 Yes +5°C g

L0380000 Levamisole hydrochloride 1 50 mg 1 0726 +5°C g

Y0000048 Levamisole - reference spectrum 1 n/a 1 1728 l

Y0001253 Levetiracetam 1 110 mg 1 100.0% C‡HŒ÷NœOœ 2535 Yes +5°C a

Y0001254 Levetiracetam impurity A 2 10 mg 1 (2RS)-2-(2-oxopyrrolidin-1-yl)butanoic acid ; Batch 1 is valid until 1 March2013

2535 +5°C a

Y0001255 Levetiracetam impurity B 1 10 mg 1 (2Z)-2-(2-oxopyrrolidin-1-yl)but-2-enamide 2535 +5°C a

Y0001256 Levetiracetam impurity C 1 10 mg 1 pyridin-2-ol 2535 +5°C g

Y0001257 Levetiracetam impurity D 1 10 mg 1 (2R)-2-(2-oxopyrrolidin-1-yl)butanamide ((R)-etiracetam) 2535 +5°C a

L0390000 Levocabastine hydrochloride 1 125 mg 1 1484 +5°C a

L0390008 Levocabastine impurity D 1 20 mg 1 1-[cis-4-cyano-4-(4-fluorophenyl)cyclohexyl]-4-phenylpiperidine-4-carboxylic acid

1484 +5°C a

L0399900 Levocarnitine 2 125 mg 1 1339 +5°C a

L0399905 Levocarnitine impurity A 2 50 mg 1 (E)- or (Z)-4-(trimethylammonio)but-2-enoate 1339 +5°C a

L0400000 Levodopa 2 100 mg 1 0038 +5°C g

L0420000 Levodropropizine 1 60 mg 1 1535 +5°C a

L0420002 Levodropropizine impurity A 2 20 mg 1 (2R)-3-(4-phenylpiperazin-1-yl)propane-1,2-diol (dextrodropropizine) 1535 +5°C a

Y0001033 Levodropropizine impurity B 1 50 mg 1 1-phenylpiperazine 1535 +5°C g

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Y0001048 Levodropropizine impurity C 1 300 mg 1 2,3-epoxypropan-1-ol 1535 -20°C g(c)

L0500000 Levomepromazine hydrochloride 1 100 mg 1 0505 +5°C a

L0505000 Levomepromazine maleate 1 50 mg 1 0925 +5°C a

L0551000 Levonorgestrel 2 30 mg 1 0926 +5°C a

Y0001379 Levonorgestrel impurity B 1 10 mg 1 13-ethyl-17-hydroxy-18,19-dinor-17-alpha-pregn-5(10)-en-20-yn-3-one 0926 +5°C a

Y0001431 Levonorgestrel for system suitability 1 10 mg 1 0926 Yes +5°C a

L0570000 Levothyroxine sodium 3 100 mg 1 89.3% CŒ—HŒÐI÷NNaO÷ 0401,0728 -20°C c

Y0001382 Levothyroxine for peak identification 1 10 mg 1 0401 Yes -20°C c

L0595000 Lidocaine 1 50 mg 1 0727 +5°C a

L0600000 Lidocaine hydrochloride 2 100 mg 1 0227,1242,13

63

+5°C g

L0650000 Lincomycin hydrochloride 3 250 mg 1 95.4% CŒ‡H–—ClNœOÿS 0582,0583,09

96

Yes +5°C a

Y0001393 Lincomycin hydrochloride for system suitability 1 10 mg 1 0583 Yes -20°C c

L0700000 Liothyronine sodium 7 50 mg 1 96.6 % CŒ—HŒŒI–NNaO÷ 0401,0728 -20°C c

Y0000860 Liothyronine for peak identification 1 0.0046 mg 1 0728 -20°C c

L0702000 Lisinopril dihydrate 2 50 mg 1 1120 +5°C a

Y0001235 Lisinopril for system suitability 1 2 mg 1 Lisinopril for performance test CRS 3 renamed as lisinopril for system suitability CRS 1 for the implementation of 01/2011:1120

1120 Yes +5°C a

Y0001234 Lisinopril impurity F 1 0.01 mg 1 (2S)-1-[(2S)-6-amino-2-[[(1S)-1-carboxy-3-cyclohexylpropyl]amino]hexanoyl]pyrrolidine-2-carboxylic acid (cyclohexyl analogue)

1120 +5°C a

L0720000 Lithium clavulanate 5 125 mg 1 97.6% C‡H‡LiNO—; 1 mg of C‡H‡LiNO— corresponds to 1.157 mg of C‡H‡KNO— 1140,1653 Yes +5°C a

L0720800 Lithocholic acid 2 60 mg 1 1189,1275 +5°C a

Y0000112 Lobeline hydrochloride 1 50 mg 1 1988 +5°C a

L0745000 Lomustine 2 50 mg 1 0928 +5°C g

Y0001438 Long pepper for system suitability HRS 1 600 mg 1 2477, 2453 +5°C a

L0750000 Loperamide hydrochloride 2 50 mg 1 0921,0929,17

29

+5°C g

Y0000322 Loperamide hydrochloride for system suitability 1 15 mg 1 0929 Yes +5°C g

Y0000341 Loperamide oxide monohydrate 1 20 mg 1 1729 +5°C g

Y0001498 Lopinavir 1 200 mg 1 95.3 % C–ŸH÷‡N÷O— 2615 Yes +5°C a

Y0001506 Lopinavir for peak identification 1 10 mg 1 2615 Yes +5°C a

Y0001505 Lopinavir for system suitability 1 10 mg 1 2615 Yes +5°C a

Y0000688 Loratadine 3 60 mg 1 2124 +5°C a

Y0000603 Loratadine for system suitability 1 20 mg 1 2124 Yes +5°C a

Y0000604 Loratadine impurity F 1 10 mg 1 ethyl 4-[(11RS)-8-chloro-11-fluoro-6,11-dihydro-5H-benzo[5,6]cyclohepta[1,2-b]pyridin-11-yl]piperidine-1-carboxylate

2124 +5°C a

Y0000605 Loratadine impurity H 1 50 mg 1 ethyl 4-oxopiperidine-1-carboxylate 2124 +5°C a

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L0750500 Lorazepam - * psy 1 100 mg 1 1121 +5°C j

Y0000576 Lorazepam for system suitability - * psy 1 0.8 mg 1 1121 +5°C j

Y0000718 Lorazepam impurity D 2 10 mg 1 (5RS)-7-chloro-5-(2-chlorophenyl)-4,5-dihydro-1H-1,4-benzodiazepine-2,3- dione 1121 +5°C a

Y0001062 Losartan potassium 1 50 mg 1 2232 +5°C a

Y0001072 Losartan impurity D 2 6 mg 1 2-butyl-4-chloro-1H-imidazole-5-carbaldehyde 2232 +5°C g

Y0001076 Losartan for system suitability 2 0.0015 mg 1 Batch 1 is valid until 31 August 2012 2232 Yes +5°C a

L0790000 Lovastatin 3 60 mg 1 99.5% Cœ÷H–ÿO— ; Batch 2 is valid until 30 June 2012 1538,1563 Yes -20°C c

Y0001136 Lovastatin for peak identification 1 20 mg 1 1538 Yes -20°C c

Y0001284 Lufenuron 1 140 mg 1 99.5% CŒŸH‡ClœF‡NœO– 2177 Yes +5°C g

Y0001261 Lufenuron for peak identification 1 0.4028 mg 1 2177 Yes +5°C g

Y0001265 Lufenuron impurity G 1 15 mg 1 2,5-dichloro-4-[[[(2,6-difluorophenyl)carbonyl]carbamoyl]amino]phenyl phenyl carbonate

2177 +5°C g

L0800000 Lynestrenol 1 50 mg 1 0558 +5°C a

Y0001034 Lynestrenol for peak identification 1 20 mg 1 0558 Yes +5°C a

Y0000397 Lysine acetate 2 60 mg 1 2114 +5°C a

New L0900000 Lysine hydrochloride 3 50 mg 1 Batch 2 is valid until 31 August 2013 0805,0806,09

30, 1654

+5°C a

Y0000745 Macrogol 40 sorbitol heptaoleate 1 20 mg 1 2396 +5°C a

Y0001157 Macrogol polyvinyl alcohol grafted copolymer 1 400 mg 1 2523 +5°C a

Y0001369 Macrogol 30 dipolyhydroxystearate 1 100 mg 1 2584 +5°C a

M0088000 Magnesium aspartate dihydrate 1 60 mg 1 1445 +5°C a

Y0001289 Magnolol 1 20 mg 1 99.5% CŒ‡HŒ‡Oœ 2567 Yes -20°C g(c)

M0120000 Malathion 3 250 mg 1 99.4% CŒÐHŒ„OÿPSœ 1343 +5°C g

M0120005 Malathion impurity A 2 10 mg 1 diethyl (2RS)-2-[(methoxy)(methylsulfanyl)-S-phosphinothioyl] butane dioate 1343 -20°C g(c)

M0120010 Malathion impurity B 3 10 mg 1 diethyl (2RS)-2-(dimethoxy-S-phosphinothioyl)-butanedioate 1343 -20°C g(c)

M0100000 Maleic acid 1 100 mg 1 0365,0925 +5°C a

Y0000143 Malic acid - reference spectrum 1 n/a 1 2080 l

M0160000 Maltitol 4 1200 mg 1 99.7% CŒœHœ÷OŒŒ ; Batch 3 is valid until 31 October 2012 1235,1236 Yes +5°C a

M0200000 Mannitol 5 1200 mg 1 98.8% CÿHŒ÷Oÿ 0435,0559,13

81, 1531

Yes +5°C a

M0206000 Maprotiline hydrochloride 1 100 mg 1 1237 +5°C g

M0206040 Maprotiline impurity D 1 25 mg 1 3-(9,10-dihydro-9,10-ethanoanthracen-9-yl)-N-methylprop-2- en-1-amine 1237 +5°C g

Y0000819 Marbofloxacin 1 10 mg 1 2233 +5°C a

Y0000820 Marbofloxacin for peak identification 1 20 mg 1 2233 Yes +5°C a

M0210000 Measles vaccine (live) BRP 1 80 mg 1 4.3 logŒÐ (ie 20000) infective viral units per vial 1057,0213,24

42

Yes -20°C c

M0215000 Mebendazole 1 20 mg 1 1208,1254 +5°C a

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Y0000144 Mebendazole for system suitability 1 20 mg 1 0845 Yes +5°C a

Y0000168 Mebendazole - reference spectrum 1 n/a 1 0845 l

Y0001086 Mebrofenin 1 120 mg 1 2393 +5°C a

M0220000 Meclozine dihydrochloride 2 150 mg 1 Renamed for 01/2011:0622 ; Batch 1 is valid until 1 May 2013 0622 +5°C a

Y0001310 Meclozine impurity B 1 15 mg 1 4-chlorobenzhydrol 0622 +5°C a

Y0001311 Meclozine impurity H 1 15 mg 1 1-(4-chlorobenzhydryl)piperazine 0622 +5°C a

M0240000 Medronic acid 2 20 mg 1 0641, 2350 +5°C g

Y0001107 Medronic acid impurity A 1 60 µl 1 Tris(1-methylethoxy)phosphane 2350 +5°C g

Y0001106 Medronic acid impurity B 1 40 µl 1 Tetrakis(1-methylethyl)methhylenediphosphonate 2350 +5°C g

M0250000 Medroxyprogesterone acetate 2 100 mg 1 0673,1593 +5°C a

M0250010 Medroxyprogesterone acetate for performance test 3 50 mg 1 Batch 2 is valid until 28 February 2013 0673 +5°C a

Y0000598 Medroxyprogesterone acetate for system suitability 1 10 mg 1 0673 Yes -20°C c

M0252600 Mefenamic acid 2 50 mg 1 1240 +5°C a

Y0001081 Mefenamic acid impurity A 1 100 mg 1 2,3-dimethylaniline 1240 +5°C g

M0253000 Mefloquine hydrochloride 2 100 mg 1 Batch 1 is valid until 31 December 2012 1241 +5°C g

Y0001514 Megestrol acetate 1 120 mg 1 99.1 % Cœ÷H–œO÷ 1593 Yes +5°C a

Y0001524 Megestrol acetate for system suitability 1 50 mg 1 1593 Yes +5°C a

Y0001507 Megestrol acetate for peak identification 1 25 mg 1 1593 Yes +5°C a

M0260100 Megestrol acetate - reference spectrum 1 n/a 1 1593 l

Y0001209 Meglumine 1 10 mg 1 2055 +5°C a

Y0001080 Meloxicam 1 50 mg 1 2373 +5°C g

Y0001035 Meloxicam impurity A 1 5 mg 1 ethyl 4-hydroxy-2-methyl-2H-1,2-benzothiazine-3-carboxylate 1,1-dioxide 2373 Yes +5°C g

Y0001036 Meloxicam impurity B 1 5 mg 1 5-methylthiazol-2-amine 2373 Yes +5°C g

Y0001037 Meloxicam impurity C 2 5 mg 1 N-[(2Z)-3,5-dimethylthiazol-2(3H)-ylidene]-4-hydroxy-2-methyl-2H-1,2- benzothiazine-3-carboxamide 1,1-dioxide

2373 Yes +5°C g

Y0001039 Meloxicam impurity D 2 5 mg 1 N-[(2Z)-3-ethyl-5-methylthiazol-2(3H)-ylidene]-4-hydroxy-2-methyl-2H-1,2- benzothiazine-3-carboxamide 1,1-dioxide

2373 Yes +5°C g

Y0001158 Melphalan hydrochloride 1 100 mg 1 99.4% CŒ–HŒ‡ClœNœOœ 1698 Yes +5°C f

Y0001513 Melphalan - reference spectrum 1 1 uc 1 1698 l

Y0001457 Melphalan for system suitability 1 10 mg 1 1698 Yes +5°C f

M0300000 Menadione 1 100 mg 1 0507 +5°C g

M0350000 Menthol 4 150 mg 1 0619,0623 +5°C a

M0370000 Mepivacaine hydrochloride 1 100 mg 1 1242 +5°C a

M0370020 Mepivacaine impurity B 1 60 mg 1 (RS)-N-(2,6-dimethylphenyl)piperidine-2-carboxamide 1242 +5°C a

M0400000 Meprobamate - * psy 1 100 mg 1 0407,1689 +5°C j

M0500000 Mepyramine maleate 1 1000 mg 1 0278 +5°C a

Y0000679 Mepyramine impurity A 1 10 mg 1 N-(4-methoxybenzyl)pyridin-2-amine 0278 +5°C a

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Y0000680 Mepyramine impurity C 1 10 mg 1 pyridin-2-amine 0278 +5°C g

Y0001252 Meropenem trihydrate 1 110 mg 1 87.0% CŒŸHœ—N–O—S,3HœO 2234 Yes +5°C a

Y0000297 Mesalazine 2 125 mg 1 1699,1993 +5°C a

Y0001563 Mesalazine impurity A 1 15 mg 1 1699 +5°C g

Y0001569 Mesalazine impurity C 1 15 mg 1 1699 +5°C g

Y0001040 Mesityl oxide 1 100 mg 1 2358 +5°C g(b)

Y0000337 Mesna - reference spectrum 1 n/a 1 1674 l

Y0000316 Mesna impurity C 1 10 mg 1 2-(acetylsulphanyl)ethanesulphonic acid 1674 +5°C a

Y0000317 Mesna impurity D 1 10 mg 1 2,2'-(disulphanediyl)bis(ethanesulphonic acid) 1674 +5°C a

Y0000227 Meso-rich exametazime 1 0.5 mg 1 1925 Yes +5°C a

Y0000097 Mesterolone 2 120 mg 1 99.8% CœÐH–œOœ ; Batch 1 is valid until 30 September 2012 1730 Yes +5°C a

Y0000096 Mesterolone impurity A 1 30 mg 1 17ß-hydroxy-1alpha-methylandrost-4-en-3-one 1730 +5°C a

M0600000 Mestranol 1 100 mg 1 0509 +5°C a

Y0000301 Metacresol - reference spectrum 1 n/a 1 2077 l

M0600500 Metacycline hydrochloride 4 50 mg 1 0272,0820 +5°C a

M0600900 Metamizole sodium 3 100 mg 1 1346 +5°C a

M0600905 Metamizole impurity A 3 15 mg 1 4-formylamino-1,5-dimethyl-2-phenyl-1,2-dihydro-3H-pyrazol-3-one 1346 +5°C a

New Y0001481 Metamizole impurity E 2 0.01 mg 1 4-N-demethylanalgin ; Batch 1 is valid until 31 August 2013 1346 Yes +5°C a

M0605000 Metformin hydrochloride 3 50 mg 1 0931 +5°C a

Y0000770 Methacrylic acid-ethyl acrylate copolymer (1:1) - type A 1 200 mg 1 1128 +5°C a

Y0000323 Methacrylic acid-ethyl acrylate copolymer (1:1) - type B 1 200 mg 1 1128 +5°C a

M0610000 Methacrylic acid-ethylacrylate copolymer(1:1) - reference spectrum 1 n/a 1 1128 l

M0610030 Methacrylic acid-ethylacrylate copolymer (1:1), dispersion 30%-

ref.sp

1 n/a 1 1129 l

M0620000 Methacrylic acid-methylmethacrylate copolymer(1:1)- reference

spectrum

1 n/a 1 1127 l

M0630000 Methacrylic acid-methylmethacrylate copolymer(1:2)- reference

spectrum

1 n/a 1 1130 l

M0800000 Methadone hydrochloride - reference spectrum 1 n/a 1 0408,1787 l

Y0000428 Methanol - reference spectrum 1 n/a 1 1989 l

M0900000 Methaqualone - reference spectrum 1 n/a 1 0510 l

Y0000754 Methenamine 1 10 mg 1 1545 +5°C g

M0950000 DL-Methionine 1 50 mg 1 0624 +5°C a

M0960000 Methionine 1 50 mg 1 0788,1027 +5°C a

M1000000 Methotrexate 6 100 mg 1 88.2 % CœÐHœœN‡O— ; Batch 5 is valid until 31 January 2013 0560 Yes +5°C g

Y0000602 Methotrexate for peak identification 1 20 mg 1 0560 Yes +5°C g

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Y0000663 Methotrexate impurity C 1 10 mg 1 (2S)-2-[[4-[[(2-amino-4-oxo-1,4-dihydropteridin-6-yl)methyl]methylamino]benzoyl]amino]pentanedioic acid (N-methylfolic acid, methopteridine)

0560 +5°C g

M1000008 Methotrexate impurity D 3 10 mg 1 4-[[(2-amino-4-oxo-1,4-dihydropteridin-6-yl)methyl]methylamino]benzoic acid (N10-methylpteroic acid)

0560 +5°C g

Y0000664 Methotrexate impurity E 1 10 mg 1 4-[[(2,4-diaminopteridin-6-yl)methyl]methylamino]benzoic acid (4-amino- N10-methylpteroic acid, APA)

0560 +5°C g

M1300000 Methylatropine bromide 1 100 mg 1 0511,0919 +5°C a

M1400000 Methylatropine nitrate 1 100 mg 1 0512 +5°C a

M1450000 Methylcarbidopa 4 1 mg 1 0755 +5°C a

M1470000 Methyl 2-(4-chlorophenoxy)-2-methylpropionate 1 0.5 ml 1 0318 +5°C g

Y0001488 Methyl methacrylate 1 50 mg 1 1975 +5°C g

M1500000 Methyldopa 2 50 mg 1 0045,0755 +5°C a

Y0001374 Racemic methyldopa 1 5 mg 1 0045 +5°C a

Y0001083 Methyldopa for system suitability 1 0.024 mg 1 0045 Yes +5°C a

M1550000 Methylene chloride 2 2 ml 1 0932 +5°C g

M1551000 2-(1-Methylethyl) pentanoic acid 4 25 mg 1 0678,1378 +5°C g

M1556000 Methyl 12-hydroxystearate 2 100 mg 1 1497 +5°C a

Y0000398 Methyl nicotinate 1 25 mg 1 2129 +5°C a

Y0000776 Methylergometrine maleate 1 10 mg 1 1788 +5°C g

Y0000777 Methylergometrine for system suitability 1 0.53 mg 1 1788 Yes +5°C g

M1625000 Methylnitrosoindoline 3 100 mg 1 1108 +5°C a

M1650000 Methyl parahydroxybenzoate 3 150 mg 1 100.0% C‡H‡O–; batch 2 valid until 31/12/10 for use with monograph 2134 and 1999.

0409,1262,21

34,1999

+5°C a

Y0001017 Methylphenidate hydrochloride - * narc 1 40 mg 1 2235 +5°C k

Y0001490 Methylphenidate impurity C 1 10 mg 1 (2RS)-2-phenyl-2-[(2R)-piperidin-2-yl]ethanamide 2235 +5°C a

Y0000910 Methylphenidate impurity mixture 1 0.04 mg 1 2235 Yes +5°C a

M1700000 Methylphenobarbital - * psy 1 500 mg 1 0189 +5°C j

M1750000 Methylprednisolone 2 150 mg 1 0312,0561 +5°C a

M1755000 Methylprednisolone acetate 1 100 mg 1 0933 +5°C a

M1755200 Methylprednisolone hydrogen succinate 2 125 mg 1 0768,1131 +5°C a

M1755220 Methylprednisolone hydrogen succinate for performance test 1 50 mg 1 1131 +5°C a

Y0001376 2-methylpyrazine 1 100 mg 1 2446 +5°C g

Y0000190 N-Methylpyrrolidone - reference spectrum 1 n/a 1 1675 l

M1770180 Methyl ricinoleate 2 125 mg 1 0051,2367 +5°C a

Y0000418 Methylrosanilinium chloride 1 40 mg 1 1990 +5°C g

Y0000407 Methylrosanilinium for system suitability 1 10 mg 1 1990 Yes +5°C g

M1770200 Methyl stearate 3 100 mg 1 0051,1497 +5°C a

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M1800000 Methyltestosterone 1 100 mg 1 0410 +5°C a

Y0000861 Methyltestosterone for system suitability 1 10 mg 1 0410 Yes +5°C a

M1800900 Methylthioninium chloride 1 50 mg 1 1132 +5°C a

M1800902 Methylthioninium impurity A 2 20 mg 1 3-(dimethylamino)-7-(methylamino)phenothiazin-5-ylium 1132 +5°C a

M1808000 Metixene hydrochloride 1 75 mg 1 1347 +5°C g

M1824990 Metoclopramide 1 100 mg 1 1348 +5°C a

M1825000 Metoclopramide hydrochloride 2 50 mg 1 0674,0856,13

03

+5°C a

New M1824995 Metoclopramide impurity A 2 25 mg 1 4-(acetylamino)-5-chloro-N-(2-diethylaminoethyl)-2-methoxy benzamide ; Batch 1 is valid until 31 August 2013

1348 +5°C a

M1825010 Metoclopramide impurity E 1 40 mg 1 N,N-diethylethane-1,2-diamine 1575 +5°C g

Y0000701 Metolazone 1 80 mg 1 99.4% CŒÿHŒÿClN–O–S 1757 +5°C a

Y0000702 Metolazone for system suitability 1 10 mg 1 1757 Yes +5°C a

Y0000171 Metoprolol succinate - reference spectrum 1 n/a 1 1448 l

M1830000 Metoprolol tartrate 1 60 mg 1 1028 +5°C a

Y0000145 Metoprolol impurity A 2 10 mg 1 (2RS)-1-(ethylamino)-3-[4-(2-methoxyethyl)phenoxy]propan-2-ol 1028,1448 +5°C a

M1845000 Metrifonate 1 100 mg 1 1133 +5°C g

M1850000 Metronidazole 2 50 mg 1 0675,0934 +5°C a

M1851000 Metronidazole benzoate 1 50 mg 1 1424 +5°C a

Y0000069 Metronidazole benzoate - reference spectrum 1 n/a 1 0934 l

Y0000087 Metronidazole impurity A 2 10 mg 1 2-methyl-4-nitroimidazole 0675, 0934 +5°C a

M1860000 Mexiletine hydrochloride 1 100 mg 1 1029 +5°C a

Y0000202 Mexiletine impurity C 1 2 mg 1 1,1'-[(3,3',5,5'-tetramethylbiphenyl-4,4'-diyl)bisoxy]dipropan-2-amine 1029 +5°C a

Y0000203 Mexiletine impurity D 1 2 mg 1 (2RS)-2-(2,6-dimethylphenoxy)propan-1-amine 1029 +5°C a

M1875000 Mianserin hydrochloride 2 100 mg 1 0846 +5°C a

Y0001041 Mianserin impurity B 1 10 mg 1 (14bRS)-2-methyl-1,2,3,4,10,14b-hexahydrodibenzo[c,f]pyrazino[1,2-a]azepine-8-sulfonic acid

0846 +5°C a

Y0000862 Mianserin for system suitability 1 1.01 mg 1 0846 Yes +5°C a

M1880000 Miconazole 1 70 mg 1 0935 +5°C g

M1900000 Miconazole nitrate 1 100 mg 1 0513,1148 +5°C g

M2200000 Midazolam - * psy 2 50 mg 1 0936,1065 +5°C j

Y0000562 Midazolam impurity C 2 0.08 mg 1 acide 8-chloro-6-(2-fluorophenyl)-1-methyl-4H-imidazo[1,5-a] [1,4]benzodiazepine-3-carboxylique

0936 +5°C g

Y0000599 Midazolam for system suitability - * psy 2 1 mg 1 Batch 1 is valid until 30 June 2012 0936 Yes +5°C j

Y0000539 Milk thistle standardised dry extract 3 120 mg 1 Content silibinin A and silibinin B: 26.9 % of ; Batch 2 is valid until 31December 2012

2071,1860 Yes -20°C c

M2280000 Minocycline hydrochloride 3 125 mg 1 90.9 % Cœ–Hœ‡ClN–OŸ ; Batch 2 is valid until 31 December 2012 1030 Yes +5°C a

M2300000 Minoxidil 1 50 mg 1 0937 +5°C a

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Y0001432 Minoxidil for system suitability 1 10 mg 1 0937 Yes +5°C a

Y0000705 Mirtazapine 1 10 mg 1 2338 +5°C g

Y0000721 Mirtazapine for system suitability 1 10 mg 1 2338 Yes +5°C g

Y0000490 Misoprostol 3 60 mg 1 98.5% CœœH–‡O— 1731 Yes -20°C g(c)

Y0001162 Misoprostol for system suitability 1 5 mg 1 1731 Yes -20°C g(c)

Y0000378 Mitomycin 2 120 mg 1 99.3% CŒ—HŒ‡N÷O— ; Batch 1 is valid until 31 December 2012 1655 Yes +5°C g

M2305000 Mitoxantrone hydrochloride 3 50 mg 1 97.7% CœœH–ÐClœN÷Oÿ 1243 +5°C a

M2305005 Mitoxantrone impurity A 3 5 mg 1 1-amino-5,8-dihydroxy-4-[[2-[(2-hydroxyethyl)amino]ethyl] amino]anthracene-9,10-dione

1243 +5°C a

Y0000635 Modafinil 1 110 mg 1 100.0% CŒ—HŒ—NOœS 2307 +5°C a

Y0000636 Modafinil for system suitability 1 0.1 mg 1 2307 Yes +5°C a

Y0000251 Molgramostim 1 0.3 ml 1 13.45 mg protein per ml Cÿ–„HŒÐÐŸNŒŸŒOŒ„ÿS‡ 1641 Yes -80°C d

Y0000821 Molsidomine 1 5 mg 1 1701 +5°C a

Y0000822 Molsidomine impurity B 1 10 mg 1 N-nitrosomorpholine 1701 +5°C g(b)

Y0000823 Molsidomine impurity D 1 10 mg 1 morpholine-4-carbaldehyde 1701 +5°C a

M2900000 Mometasone furoate 2 100 mg 1 1449 +5°C a

Y0001436 Montelukast dicyclohexylamine 1 150 mg 1 99.4% C÷ŸH—„ClNœO–S 2583 Yes +5°C a

New Y0001433 Montelukast racemate 2 10 mg 1 Batch 1 is valid until 31 August 2013 2583 +5°C a

New Y0001434 Montelukast sodium 2 20 mg 1 Batch 1 is valid until 31 August 2013 2583 +5°C a

New Y0001435 Montelukast for peak identification 2 20 mg 1 Batch 1 is valid until 31 August 2013 2583 Yes +5°C a

Y0000028 Morantel hydrogen tartrate 2 50 mg 1 1546 +5°C a

Y0000451 Morphine hydrochloride (trihydrate) - * narc 2 25 mg 1 See leaflet 0097,1839,18

41

Yes +5°C k

Y0000452 Morphine sulfate - * narc 1 40 mg 1 1244,1784 +5°C k

Y0000830 Morphine for system suitability - * narc 2 15 mg 1 Batch 1 is valid until 31 August 2012 1244, 0097 Yes +5°C k

Y0000772 Moxidectin 2 70 mg 1 97.4% C–ŸH—–NO‡ ; Batch 1 is valid until 31 May 2012 1656 Yes +5°C g

Y0000747 Moxidectin for system suitability 1 10 mg 1 1656 Yes +5°C g

Y0000703 Moxifloxacin hydrochloride 2 110 mg 1 96.1 % CœŒHœ—ClFN–O÷ ; Batch 1 is valid until 31 May 2012 2254 Yes +5°C g

Y0000717 Moxifloxacin for peak identification 1 10 mg 1 2254 Yes +5°C g

Y0000226 Moxonidine 1 50 mg 1 99.7% C„HŒœClN—O 1758 +5°C g

Y0000222 Moxonidine impurity A 1 10 mg 1 4,6-dichloro-N-(imidazolidin-2-ylidene)-2-methylpyrimidin-5-amine 1758 +5°C g

M3600000 Mumps vaccine (live) BRP 1 165 mg 1 4.6 logŒÐ (ie40000) infective viral units per vial 0538,1057 Yes -80°C d

M3805000 Mupirocin - reference spectrum 1 n/a 1 1450 l

M3805500 Mupirocin calcium - reference spectrum 1 n/a 1 1451 l

M3806000 Mupirocin lithium 2 100 mg 1 93.7% CœÿH÷–O„Li 1450,1451 +5°C a

Y0000489 Mycophenolate mofetil 2 30 mg 1 1700 +5°C g

Y0000519 Mycophenolate mofetil for peak identification 5 10 mg 1 1700 Yes +5°C g

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Y0000692 Mycoplasma fermentans BRP 1 1 ml 1 20607 Yes -80°C d

Y0000690 Mycoplasma hyorhinis BRP 1 1 ml 1 20607 Yes -80°C d

Y0000691 Mycoplasma orale BRP 1 1 ml 1 20607 Yes -80°C d

Y0000689 Mycoplasma synoviae BRP 1 1 ml 1 20607 Yes -80°C d

Y0000485 Myo-inositol 1 1020 mg 1 99.8% CÿHŒœOÿ 1805 +5°C a

N0020000 Nabumetone 1 60 mg 1 99.8% CŒ—HŒÿOœ 1350 Yes +5°C a

N0020020 Nabumetone impurity D 2 10 mg 1 (E)-4-(6-methoxynaphthalen-2-yl)but-3-en-2-one 1350 +5°C a

N0020030 Nabumetone impurity F 4 10 mg 1 6,6'-dimethoxy-2,2'-binaphthalenyl 1350 +5°C a

Y0000146 Nadolol 1 100 mg 1 1789 +5°C a

Y0001215 Nadolol impurity mixture 1 0.01 mg 1 1789 Yes +5°C a

N0025000 Nadroparin calcium 1 250 mg 1 0828,1134 +5°C a

Y0000077 Naftidrofuryl - reference spectrum 1 n/a 1 1594 l

Y0000120 Naftidrofuryl impurity A 1 10 mg 1 2-[(naphtalen-1-yl)methyl]-3-(tetrahydrofuran-2-yl)propanoic acid 1594 +5°C a

Y0000121 Naftidrofuryl impurity B 2 25 mg 1 ethyl 2-[(naphtalen-1-yl)methyl]- 3-(tetrahydrofuran-2-yl)propanoate ; Batch1 is valid until 31 December 2012

1594 +5°C a

Y0000331 Naftidrofuryl impurity F 1 10 mg 1 2-[(diethylamino)ethyl 2-[(naphthalen-2-yl)methyl]-3- (tetrahydrofuran-2-yl)propanoate

1594 +5°C a

N0050000 Nalidixic acid 1 100 mg 1 0701 +5°C a

N0075000 Naloxone hydrochloride dihydrate 2 100 mg 1 0729,2099 +5°C a

Y0000695 Naloxone for peak identification 1 10 mg 1 0729 Yes +5°C a

Y0000400 Naltrexone hydrochloride 1 50 mg 1 1790 +5°C a

Y0000410 Naltrexone impurity C 1 15 mg 1 N-(3-butenyl)-noroxymorphone 1790 +5°C a

Y0000542 Nandrolone decanoate 1 5 mg 1 1992 -20°C c

Y0000547 Nandrolone decanoate for peak identification 1 10 mg 1 1992 Yes -20°C c

Y0000548 Nandrolone decanoate for system suitability 1 10 mg 1 1992 -20°C c

N0080000 Naphazoline hydrochloride 3 50 mg 1 0730,1162 +5°C g

N0100000 Naphazoline nitrate 2 10 mg 1 0147 +5°C a

N0200000 Naphazoline impurity A 5 10 mg 1 N-(2-aminoethyl)-2-(naphthalen-1-yl)acetamide(naphthylacetylethylenediamine)

0147,0730 +5°C g

N0250000 Naproxen 2 100 mg 1 Batch 1 is valid until 1 June 2013 0731,1702 +5°C g

Y0000399 Naproxen (racemic) 1 10 mg 1 0731,1702 +5°C g

Y0000631 Naproxen impurity L 1 10 mg 1 1-(6-methoxynaphthalen-2-yl)ethanone 1702 +5°C g

Y0001378 Naringin 1 20 mg 1 88.3% CœŸH–œOŒ÷ 2563 Yes +5°C a

Y0001437 Nateglinide 1 200 mg 1 99.9% CŒ„HœŸNO– 2575 Yes +5°C a

Y0001440 Nateglinide impurity A 1 10 mg 1 trans-4-(1-methylethyl)cyclohexanecarboxylic acid 2575 +5°C a

Y0001441 Nateglinide impurity B 1 15 mg 1 N-[[trans-4-(1-methylethyl)cyclohexyl]carbonyl]-Lphenylalanine (L- phenylalanine isomer)

2575 +5°C a

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Y0001442 Nateglinide impurity C 1 10 mg 1 N-[[cis-4-(1-methylethyl)cyclohexyl]carbonyl]-D-phenylalanine (cis-isomer) 2575 +5°C a

N0300000 Neamine 4 0.5 mg 1 76.3% CŒœHœÿN÷Oÿ 0180,0197 Yes +5°C a

N0399000 Neohesperidin-dihydrochalcone 1 125 mg 1 89.9% Cœ‡H–ÿOŒ— 1547 Yes -20°C a

N0399004 Neohesperidin-dihydrochalcone impurity B 2 10 mg 1 86.4% Cœ‡H–œOŒ— ; 7-[[2-O-(6-deoxy-¶-L-mannopyranosyl) -ß-D- glucopyranosyl]oxy]-5-hydroxy-2-(3-hydroxy-4-methoxyphenyl)-4H-1- benzopyran-4-one (neodiosmin)

1547 Yes +5°C a

N0400000 Neomycin sulfate 3 50 mg 1 Not to be used for microbiological assay 0032,0033,00

53,

0180,0197,04

85, 0645

Yes -20°C a

New N0401000 Neomycin sulfate for microbiological assay 4 25 mg 1 19850 IU per vial ; Batch 3 is valid until 31 August 2013 0197,20702 Yes -20°C a

N0500000 Neostigmine bromide 1 50 mg 1 0046 +5°C g

N0550000 Neostigmine metilsulfate 1 50 mg 1 0626 +5°C g

N0559000 Netilmicin sulfate 1 25 mg 2 14656 IU per vial 1351,20702 -20°C a

Y0000520 Nevirapine (anhydrous) 1 30 mg 1 99.8% CŒ—HŒ÷N÷O 2255, 2479 +5°C a

Y0000521 Nevirapine for peak identification 1 0.058 mg 1 2255, 2479 Yes +5°C a

Y0001499 Nevirapine hemihydrate 1 15 mg 1 2479 +5°C a

Y0000388 Newcastle Disease Vaccine (inactivated) BRP 1 40 mg 1 The kit contains :1 vial BRP1 NDV reference antigen, 1 vial BRP1 NDV control antigen, 1 vial BRP1 NDV coating antibody, 1 vial BRP1 NDV conjugated, detection antibody

0870 Yes -20°C c

Y0001373 Nicergoline 1 50 mg 1 1998 +5°C g

Y0000287 Nicergoline - reference spectrum 1 n/a 1 1998 l

Y0000283 Nicergoline impurity A 1 10 mg 1 [(6aR,9R,10aS)-10a-methoxy-4,7-dimethyl-4,6,6a,7,8,9,10,10a- octahydroindol[4,3-fg]quinolin-9-yl]methyl 5-chloropyridine-3-carboxylate

1998 +5°C g

Y0001356 Nicergoline impurity D 1 20 mg 1 5-bromopyridine-3-carboxylic acid 1998 +5°C g

Y0001362 Nicergoline for peak identification 1 1 mg 1 1998 +5°C g

Y0001352 Nicergoline for system suitability 1 10 mg 1 1998 Yes +5°C g

N0560000 Niclosamide (anhydrous) 1 50 mg 1 0679,0680 +5°C g

N0600000 Nicotinamide 1 50 mg 1 0047 +5°C a

N0590000 Nicotine - reference spectrum 1 n/a 1 1452,1792 l

N0590200 Nicotine ditartrate 4 120 mg 1 92.8% CŒÐHŒ÷Nœ x 2 C÷HÿOÿ ; Batch 3 is valid until 1 May 2013 1792 Yes +5°C g

Y0001425 Nicotine ditartrate dihydrate 1 15 mg 1 2599 +5°C g

Y0001023 Nicotine for system suitability 3 1 mg 1 Batch 2 is valid until 30 June 2012 1452, 1792,

2599

Yes -20°C g(c)

N0700000 Nicotinic acid 1 100 mg 1 0459,0859 +5°C a

Y0001268 Nicotinic acid impurity mixture 1 0.12 mg 1 0459 Yes +5°C g

N0750000 Nifedipine 1 50 mg 1 0627,1013 +5°C a

N0750010 Nifedipine impurity A 1 20 mg 1 Dimethyl 2,6-dimethyl-4-(2-nitrophenyl)pyridine-3,5-dicarboxylate 0627 +5°C a

N0750015 Nifedipine impurity B 1 20 mg 1 Dimethyl 2,6-dimethyl-4-(2-nitrosophenyl)pyridine-3,5-dicarboxylate 0627 +5°C a

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Y0000824 Niflumic acid 1 10 mg 1 2115 +5°C g

Y0000825 Niflumic acid impurity A 1 10 mg 1 2-chloropyridine-3-carboxylic acid 2215 +5°C a

Y0000826 Niflumic acid impurity B 1 10 mg 1 2-hydroxy-N-(3-(trifluoromethyl)phenyl)pyridine-3-carboxamide 2115 +5°C g

Y0000827 Niflumic acid impurity E 1 15 mg 1 6-((3-(trifluoromethyl)phenyl)amino)pyridine-3-carboxylic acid 2115 +5°C g

Y0000836 Nifuroxazide 1 10 mg 1 1999 +5°C a

N0800000 Nikethamide 1 1 ml 1 0233 +5°C g

Y0000829 Nilutamide 1 110 mg 1 2256 +5°C g

Y0000894 Nilutamide impurity B 1 5 mg 1 4-nitro-3-(trifluoromethyl)aniline 2256 +5°C a

N0845000 Nimesulide 2 100 mg 1 1548 +5°C g

Y0001237 Nimesulide for peak identification 1 10 mg 1 1548 Yes +5°C g

N0845008 Nimesulide impurity D 4 0.004 mg 1 4-nitro-2-phenoxyaniline ; Batch 3 is valid until 31 October 2012 1548 +5°C g

N0850000 Nimodipine 2 50 mg 1 1245 +5°C a

N0850010 Nimodipine impurity A 4 1 mL 1 2-methoxyethyl 1-methylethyl 2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5-dicarboxylate ; Batch 3 is valid until 1 June 2013

1245 Yes +5°C a

N0900000 Nitrazepam - * psy 1 100 mg 1 0415,0898,11

21

+5°C j

N0900010 Nitrazepam impurity A 2 25 mg 1 3-amino-6-nitro-4-phenylquinol-2-one 0415 +5°C a

N0905000 Nitrendipine 2 60 mg 1 1246 +5°C a

Y0001456 Nitrendipine for peak identification 1 10 mg 1 1246 Yes +5°C a

N0905005 Nitrendipine impurity A 3 30 mg 1 ethyl methyl-2,6-dimethyl-4-(3-nitrophenyl)pyridine-3,5- dicarboxylate; (nitrophenylpyridine analogue)

1246 +5°C a

N0930000 Nitric oxide - reference spectrum 1 n/a 1 1550 l

N0950000 Nitrofural 1 100 mg 1 99.8% CÿHÿN÷O÷ 1135 +5°C a

Y0001377 Nitrofural for peak identification 1 0.11 mg 1 1135 +5°C a

N1000000 Nitrosotriaminopyrimidine 1 50 mg 1 0058 +5°C a

N1090000 Nizatidine 1 250 mg 1 99.3% CŒœHœŒN—OœSœ 1453 +5°C a

Y0001278 Nizatidine for system suitability 1 10 mg 1 1453 Yes +5°C a

N1090060 Nizatidine impurity F 1 10 mg 1 (EZ)-NÁ,NÁ'-[thiazole-2,4-diylbis(methylenesulphanediylethylene)]bis(N'- methyl-2-nitroethene-1,1-diamine)

1453 +5°C a

N1080000 Nomegestrol acetate 1 100 mg 1 1551 +5°C a

N1080005 Nomegestrol acetate impurity A 2 50 mg 1 6alpha-methyl-3,20-dioxo-19-norpregn-4-en-17-yl acetate 1551 +5°C a

Y0001314 1-nonadecanol 1 400 mg 1 0801,0802,08

47

+5°C a

Y0000670 Nonivamide 1 10 mg 2 99.1% CŒŸHœŸNO– 2336,2337 +5°C a

Y0000755 Nonoxinol 9 1 10 mg 1 1454 +5°C g

N1100000 Noradrenaline tartrate 6 200 mg 1 Batch 5 is valid until 31 August 2012 0254,0285,07

32, 2303

+5°C g

Y0000681 Noradrenaline impurity D 1 15 mg 1 4[(1R)-2-amino-1-methoxyethyl]benzene-1,2-diol (noradrenaline methyl ether 0285,0732 +5°C g

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Y0000682 Noradrenaline impurity E 1 10 mg 1 2-chloro-1-(3,4-dihydroxyphenyl)ethanone 0285,0732 +5°C g

Y0000686 Noradrenaline impurity F 1 10 mg 1 N-benzyl-1-phenylmethanamine 0285,0732 +5°C a

N1130000 Norcyclobenzaprine 1 25 mg 1 0941 +5°C a

N1140000 Nordazepam -* psy 1 50 mg 1 Dipotassium clorazepate impurity B 0898,1466 +5°C j

N1200000 Norethisterone 2 100 mg 1 0234,1212,09

26

+5°C a

N1225000 Norethisterone acetate 1 100 mg 1 0850 +5°C a

Y0000522 Norethisterone for system suitability 1 10 mg 1 0234 Yes -20°C c

N1230000 Norfloxacin 1 50 mg 1 1248 +5°C a

N1230010 Norfloxacin impurity A 1 20 mg 1 7-chloro-1-ethyl-6-fluoro-4-oxo-1,4-dihydroquinoline-3-carboxylic acid(corresponding also to pefloxacin impurity F)

1460 +5°C a

Y0001015 Norfloxacin for system suitability 2 8 mg 1 1248 Yes +5°C a

Y0001301 Norfloxacin for peak identification 1 10 mg 1 1248 Yes +5°C a

Y0000724 Norgestimate 1 10 mg 1 1732 +5°C a

Y0000725 Norgestimate for system suitability 1 5 mg 1 1732 Yes +5°C a

N1250000 Norgestrel 1 30 mg 1 0940 +5°C a

N1279000 Norpseudoephedrine hydrochloride - * psy 2 50 mg 1 Cathine hydrochloride 0683 +5°C j

N1280000 Nortriptyline hydrochloride 2 10 mg 1 0941 +5°C a

Y0001296 Nortriptyline for system suitability 1 20 mg 1 0941 +5°C a

N1300000 Noscapine 1 100 mg 1 0102,0515,05

16

+5°C a

New N1400000 Nystatin 7 100 mg 1 5880 IU per mg ; Batch 6 is valid until 31 August 2013 0517,1292,20

702

Yes -20°C c

O0100900 Octoxinol 10 2 300 mg 1 1553 +5°C g

Y0000368 Octyl gallate 1 30 mg 1 2057 +5°C a

O0101000 Octyldodecanol 4 400 mg 1 94.8% CœÐH÷œO 1136 +5°C a

O0120000 Ofloxacin 1 50 mg 1 1455 +5°C a

O0120010 Ofloxacin impurity A 2 20 mg 1 (RS)-9,10-difluoro-3-methyl-7-oxo-2,3-dihydro-7H-pyrido [1,2,3-de][1,4]benzoxazine-6-carboxylic acid (FPA)

1455 +5°C a

O0120050 Ofloxacin impurity E 3 20 mg 1 (RS)-9-fluoro-3-methyl-10-(piperazin-1-yl)-7-oxo-2,3-dihydro-7H-pyrido[1,2,3-de][1,4]benzoxazine-6-carboxylic acid

1455 +5°C a

Y0001370 Olanzapine 1 200 mg 1 99.8% CŒŸHœÐN÷S 2258 Yes +5°C g

Y0001392 Olanzapine impurity A 1 5 mg 1 5-methyl-2-[(2-nitrophenyl)amino]thiophene-3-carbonitrile 2258 +5°C g

Y0001380 Olanzapine for system suitability 1 10 mg 1 2258 Yes +5°C g

Y0001204 Oleanolic acid 1 20 mg 1 2472 Yes +5°C a

Y0001479 Oleic acid 1 2000 mg 1 98.3% CŒ‡H–÷Oœ 2579 Yes +5°C a

Y0001113 Triolein 1 30 mg 1 98.7 % C—ŸHŒÐ÷Oÿ 2454 Yes -20°C c

Y0000805 Oleuropein 1 20 mg 1 82.2% Cœ—H–œOŒ– 1878 +5°C a

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Y0001405 Olmesartan medoxomil 1 100 mg 1 99.3 % Cœ„H–ÐNÿOÿ 2600 Yes +5°C a

Y0001424 Olmesartan medoxomil for system suitability 1 10 mg 1 2600 Yes +5°C a

O0146000 Olsalazine sodium 1 60 mg 1 1457 +5°C a

O0146010 Olsalazine sodium for performance test 1 60 mg 1 1457 Yes +5°C a

O0150000 Omeprazole 4 50 mg 1 Batch 3 is valid until 31 May 2012 0942,1032 Yes -20°C c

Y0001043 Omeprazole magnesium 1 10 mg 1 2374 +5°C a

Y0001042 Omeprazole for peak identification 1 10 mg 1 0942,2372,23

74

Yes -20°C c

O0151000 Omeprazole impurity D 2 10 mg 1 Omeprazole sulphone 0942,1032 -20°C c

Y0000218 Ondansetron hydrochloride dihydrate 4 200 mg 1 89,9% CŒ‡HœÐClN–O ; Batch 3 is valid until 1 June 2013 2016 Yes +5°C g

Y0000197 Ondansetron for LC system suitability 1 10 mg 1 2016 +5°C g

Y0000196 Ondansetron for TLC system suitability 1 30 mg 1 2016 +5°C g

Y0001345 Ondansetron impurity A 1 10 mg 1 (3RS)-3-[(dimethylamino)methyl]-9-methyl-1,2,3,9-tetrahydro-4H- carbazol-4-one

2016 +5°C g

Y0000195 Ondansetron impurity D 2 10 mg 1 9-methyl-3-methylene-1,2,3,9-tetrahydro-4H-carbazol-4-one 2016 +5°C g

Y0001326 Ondansetron impurity E 1 10 mg 1 Imidazole 2016 +5°C g

Y0001320 Ondansetron impurity F 1 10 mg 1 2016 +5°C g

Y0001346 Ondansetron impurity G 1 10 mg 1 (3RS)-3-[(1H-imidazol-1-yl)methyl]-9-methyl-1,2,3,9-tetrahydro-4H- carbazol-4-one (C-demethylondansetron)

2016 +5°C g

Y0001125 Orbifloxacin 1 200 mg 1 2259 +5°C a

Y0001147 Orbifloxacin impurity mixture 1 0.0008 mg 1 2259 Yes +5°C a

O0180000 Orciprenaline sulfate 2 100 mg 1 1033,1332 +5°C a

Y0000895 Orciprenaline for system suitability 1 5 mg 1 1033 Yes +5°C a

Y0001501 Orientvine stem HRS 1 600 mg 1 2450 Yes +5°C a

Y0000100 Orphenadrine hydrochloride 1 100 mg 1 1760 +5°C g

Y0000101 Orphenadrine citrate 1 100 mg 1 1759 +5°C g

Y0001337 Oseltamivir phosphate (impurity B free) 1 300 mg 1 99.7% CŒÿH–ŒNœO‡P 2422 Yes +5°C a

Y0001181 Orphenadrine for peak identification 1 0.42 mg 1 1759,1760 Yes +5°C g

Y0001338 Oseltamivir impurity A 1 10 mg 1 (3R,4R,5S)-5-acetamido-4-amino-3-(1-ethylpropoxy)cyclohex-1-ene-1- carboxylic acid

2422 +5°C a

Y0000102 Orphenadrine impurity E 2 60 mg 1 (RS)-N,N-dimethyl-2-[(3-methylphenyl)phenylmethoxy] ethanamine (meta- methylbenzyl isomer) ; Batch 1 is valid until 1 May 2013

1759,1760 +5°C g

Y0001339 Oseltamivir impurity B 1 10 mg 1 ethyl (1R,2R,3S,4R,5S)-4-acetamido-5-amino-2-azido-3- (1-ethylpropoxy)cyclohexanecarboxylate

2422 +5°C a

Y0001340 Oseltamivir impurity C 1 10 mg 1 (3R,4R,5S)-4-acetamido-5-amino-3-(1-ethylpropoxy)cyclohex-1-ene-1- carboxylic acid

2422 +5°C a

Y0001341 Oseltamivir impurity H 1 30 mg 1 tributylphosphane oxide 2422 +5°C g

Y0001207 Osthole 1 20 mg 1 98.3 % CŒ—HŒÿO– 2557 Yes +5°C a

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O0200000 Ouabain 2 150 mg 1 80.0% Cœ„H÷÷OŒœ 0048 Yes +5°C g

Y0000638 Oxacillin sodium monohydrate 1 110 mg 1 93.8% CŒ„HŒ‡N–NaO—S 2260 +5°C a

Y0000560 Oxacillin for peak identification 1 10 mg 1 2260 Yes +5°C a

Y0000271 Oxaliplatin 4 250 mg 1 99.9% C‡HŒ÷NœO÷Pt ; Batch 3 is valid until 1 June 2013 2017 Yes +5°C g

Y0000272 Oxaliplatin impurity B 8 22 mg 1 91,2% CÿHŒ‡NœOœPt; (SP-4-2)-diaqua[(1R,2R)-cyclohexane-1,2-diamine- kN,kN']platinum (diaquodiaminocyclohexaneplatinum) ; Batch 6 is valid until 31 July2012Batch 7 is valid until 1 June 2013

2017 Yes +5°C g

Y0000273 Oxaliplatin impurity C 5 25 mg 1 (OC-6-33)-[(1R,2R)-cyclohexane-1,2-diamine-kN,kN'][ethane-dioato(2-)- kO1,kO2]dihydroxyplatinum ; Batch 4 is valid until 1 April 2013

2017 +5°C g

Y0000274 Oxaliplatin impurity D 3 10 mg 1 (SP-4-2)-[(1S,2S)-cyclohexane-1,2-diamine-kN,kN'][ethane- dioato(2-)-kO1,kO2]platinum (S,S-enantiomer of oxaliplatin)

2017 +5°C g

O0225000 Oxazepam - * psy 2 50 mg 1 0778 +5°C j

Y0000543 Oxazepam for peak identification 2 0.008 mg 1 Batch 1 is valid until 1 March 2013 0778 Yes +5°C a

New Y0001549 Oxcarbazepine impurity mixture 1 0.008 mg 1 2577 Yes +5°C a

Y0000350 Oxeladin hydrogen citrate 1 50 mg 1 1761 +5°C g

Y0000404 Oxeladin impurity C 1 10 mg 1 2-(diethylamino)ethyl 2-ethyl-2-phenylbutanoate 1761 +5°C g

Y0000390 Oxeladin impurity D 1 20 mg 1 2-(2-diethylaminoethoxy)ethyl 2-phenyl-butyrate dihydrogen citrate 1761 +5°C g

O0225800 Oxfendazole for veterinary use 2 50 mg 1 1458 +5°C g

Y0000224 Oxfendazole impurity B 1 10 mg 1 methyl [5-(phenylsulphonyl)-1H-benzimidazole-2-yl]carbamate 1458 +5°C g

Y0000225 Oxfendazole with impurity D 1 10 mg 1 1458 +5°C g

Y0000709 Oxitropium bromide 1 50 mg 1 2170 +5°C a

Y0000715 Oxitropium bromide impurity B 1 15 mg 1 (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 (methylhyoscine)

2170 +5°C a

Y0000713 Oxitropium bromide impurity D 1 10 mg 1 (1R,2R,4S,5S,7s,9r)-9-ethyl-9-methyl-7-[(2-phenylprop-2-enoyl)oxy]-3- oxa-9-azoniatricyclo[3.3.1.02,4]nonane (apo-N-ethylhyoscine)

2170 +5°C g

O0240000 Oxolinic acid 1 50 mg 1 1353 +5°C a

O0240005 Oxolinic acid impurity A 1 20 mg 1 8-hydroxy-1,3-dioxolo[4,5-g]quinoline-7-carboxylic acid 1353 +5°C a

O0240010 Oxolinic acid impurity B 1 20 mg 1 ethyl 5-ethyl-8-oxo-5,8-dihydro-1,3-dioxolo[4,5-g]quinoline-7- carboxylate 1353 +5°C a

O0250000 Oxprenolol hydrochloride 1 50 mg 1 0628,0876,10

72

+5°C g

O0260000 Oxibendazole 2 100 mg 1 1386 +5°C a

O0270000 Oxybuprocaïne hydrochloride 1 150 mg 1 1251 +5°C a

O0288000 Oxybutynin hydrochloride 1 150 mg 1 1354 +5°C g

O0288005 Oxybutynin impurity A 3 10 mg 1 90.9% CœœH––NO–; 4-(diethylamino)but-2-ynyl(¢£)-2-(cyclohex-3-enyl)-2- cyclohexyl-2-hydroxyacetate

1354 Yes +5°C g

Y0000492 Oxycodone hydrochloride - * narc 1 100 mg 1 1793 +5°C k

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Y0000453 Oxycodone impurity D 2 50 mg 1 7,8-didehydro-4,5 alpha-epoxy-14-hydroxy-3-methoxy -17- methylmorphinan-6-one (14-hydroxycodeinone)

1793 +5°C a

O0290000 Oxymetazoline hydrochloride 2 80 mg 1 0943 +5°C f

Y0001044 Oxymetazoline impurity A 1 10 mg 1 N-(2-aminoethyl)-2-[4-(1,1-dimethylethyl)-3-hydroxy-2,6-dimethylphenyl]acetamide

0943 +5°C f

O0400000 Oxytetracycline 7 100 mg 1 89.9% CœœHœ÷NœO„ ; Batch 6 is valid until 31 December 2012 0198,0199 Yes +5°C g

O0500000 Oxytetracycline hydrochloride 4 20 mg 1 0198,1030 +5°C g

O0700000 Oxytocin 4 1 mg 1 0.96 mg per vial of C÷–HÿÿNŒœOŒœSœ 0779,0780 -20°C g(c)

O0770000 Oxytocin/Desmopressin validation mixture 3 20.2 mg 1 about 0.1 mg oxytocin + 0.1 mg desmopressin per vial 0712,0779,07

80

-20°C c

Y0000698 Paclitaxel 2 40 mg 1 99.4% C÷ŸH—ŒNOŒ÷ 1794 Yes +5°C a

Y0000699 Paclitaxel impurity C 1 5 mg 1 N-debenzoyl-N-hexanoylpaclitaxel 1794 +5°C a

Y0000700 Paclitaxel natural for peak identification 1 10 mg 1 1794 Yes +5°C a

Y0000719 Paclitaxel semi-synthetic for peak identification 1 10 mg 1 1794 Yes +5°C a

Y0000739 Paclitaxel semi-synthetic for system suitability 2 1.013 mg 1 Batch 1 is valid until 1 April 2013 1794 Yes +5°C a

P0090000 Palmitic acid 4 100 mg 1 0229,0882,14

74,2058,1663

+5°C a

Y0000524 Pamidronate disodium pentahydrate 1 10 mg 1 1779 +5°C a

P0100000 Pancreas powder (amylase and lipase) BRP 3 2000 mg 1 41.4 Ph. Eur. U. lipolytic activity per mg; 56.3 Ph. Eur. U. amylolytic activity per mg

0350 Yes +5°C a

P0200000 Pancreas powder (protease) BRP 3 2000 mg 1 1.48 Ph. Eur. U. per mg 0350 Yes +5°C a

P0250000 Pancuronium bromide 2 20 mg 1 Vecuronium impurity B 0681,1769 +5°C g

Y0000577 Pancuronium bromide for system suitability 1 20 mg 1 0681 +5°C g

Y0000835 Pantoprazole sodium sesquihydrate 1 20 mg 1 2296 +5°C a

Y0001001 Pantoprazole for system suitability 4 0.5055 mg 1 2296 Yes +5°C a

P0270000 Papaverine hydrochloride 1 25 mg 1 0102,0573 +5°C g

P0300000 Paracetamol 4 50 mg 1 Batch 3 is valid until 31 December 2012 0049 +5°C a

Y0000780 Paraffin (hard) 1 10 mg 1 1034 +5°C a

Y0000058 Paraffin (liquid) - reference spectrum 1 n/a 1 0239,0240 l

Y0000913 Paraffin (White soft) 1 10 mg 1 1799 +5°C a

Y0000912 Paraffin (Yellow soft) 1 10 mg 1 1554 +5°C a

P0305000 Parnaparin sodium 1 250 mg 1 0828,1252 +5°C a

Y0000578 Paroxetine hydrochloride (anhydrous) 1 100 mg 1 2283 +5°C g

Y0000281 Paroxetine hydrochloride hemihydrate 2 200 mg 1 97.4% CŒ„HœŒClFNO– 2018,2283 +5°C g

Y0000233 Paroxetine impurity A 4 15 mg 1 (3S,4R)-3-[[1,3-benzodioxol-5-yloxy]methyl]-4-phenylpiperidine(desfluoroparoxetine)

2018,2283 +5°C g

Y0000579 Paroxetine hydrochloride (anhydrous) impurity C 1 10 mg 1 (3S,4R)-3-[(1,3-benzodioxol-5-yloxy)methyl]-1-benzyl-4-(4-fluorophenyl)piperidine (N-benzylparoxetine)

2283 +5°C g

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Y0000256 Paroxetine impurity D 2 5 mg 1 (3R,4S)-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)piperidine((+)-trans-paroxetine)

2018,2283 +5°C g

Y0000580 Paroxetine impurity E 1 5 mg 1 (3RS,4RS)-3-[(1,3-benzodioxol-5-yloxy)methyl]-4-(4fluorophe- nyl)piperidine(cis-paroxetine)

2283 +5°C g

Y0000581 Paroxetine hydrochloride (anhydrous) impurity H 1 10 mg 1 [(3S,4R)-1-benzyl-4-(4-fluorophenyl)piperidin-3-yl]methanol 2283 +5°C g

Y0000630 Paroxetine for system suitability 1 5 mg 1 2018 +5°C g

P0309000 Pefloxacin mesilate dihydrate 1 200 mg 1 1460 +5°C a

P0309020 Pefloxacin impurity B 1 10 mg 1 1-ethyl-6-chloro-7-(4-methylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3- carboxylic acid (chlorinated homologue of pefloxacin)

1460 +5°C a

P0309030 Pefloxacin impurity C 2 0.01 mg 1 1-ethyl-6-fluoro-5-(4-methylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3- carboxylic acid (isopefloxacin)

1460 +5°C a

Y0001539 Pemetrexed disodium heptahydrate 1 200 mg 1 78.6 % 2637 Yes +5°C a

Y0001538 Pemetrexed for system suitability 1 20 mg 1 2637 +5°C a

Y0001535 Pemetrexed impurity mixture 1 0.002 mg 1 2637 Yes +5°C a

P0307000 Penbutolol sulfate 1 100 mg 1 1461 +5°C g

New P0307005 Penbutolol impurity A 2 20 mg 1 (2S)-1-[2-(cyclopent-1-enyl)phenoxy]-3-[(1,1-dimethylethyl) amino]propan-2-ol ; Batch 1 is valid until 7 February 2013

1461 +5°C g

P0310000 Penicillamine 1 100 mg 1 0566 +5°C a

P0320000 Penicillamine disulfide 2 100 mg 1 93.0% CŒÐHœÐNœO÷Sœ; 3,3-(disulphanediyl)bis[(2S)-2-amino-3- methylbutanoic] acid

0566 +5°C a

P0400100 Pentaerythrityl tetranitrate diluted 2 600 mg 1 10.0% C—H‡N÷OŒœ 1355 +5°C h

P0405000 Pentamidine diisetionate 1 30 mg 1 1137,1436 +5°C a

P0405500 Pentazocine - reference spectrum 1 n/a 1 1462 l

P0405510 Pentazocine hydrochloride - reference spectrum 1 n/a 1 1463 l

Y0000417 Pentazocine lactate - reference spectrum 1 n/a 1 2000 l

Y0001051 Pentetate sodium calcium 1 100 mg 1 2353 +5°C a

P0500000 Pentobarbital - * psy 1 500 mg 1 0200,0419 +5°C j

P0510000 Pentoxifylline 1 100 mg 1 0851 +5°C a

Y0000076 Pentoxyverine hydrogen citrate - reference spectrum 1 n/a 1 1621 l

Y0000098 Pentoxyverine impurity A 1 10 mg 1 1-phenylcyclopentanecarboxylic acid 1621 +5°C a

Y0000099 Pentoxyverine impurity B 1 10 mg 1 2-(diethylamino)ethyl 1-phenylcyclopentanecarboxylate (caramiphen) 1621 +5°C a

P0525000 Pepsin powder 2 2000 mg 1 0.99 Ph. Eur. U. per mg 0682 Yes +5°C a

Y0000010 Pergolide mesilate 1 150 mg 1 99.9% CœÐH–ÐNœO–Sœ 1555 +5°C f

Y0000237 Perindopril impurity A 2 10 mg 1 (2S,3aS,7aS)-octahydro-1Hindole-2-carboxylic acid ; Batch 1 is valid until 1May 2013

2019 +5°C a

Y0000207 Perindopril for stereochemical purity 2 40 mg 1 Batch 1 is valid until 1 June 2013 2019 Yes +5°C a

Y0000238 Perindopril tert-butylamine 2 40 mg 1 2019 +5°C a

Y0000771 Perindopril for peak identification 1 5 mg 1 2019 Yes +5°C a

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P0550000 Perphenazine 1 100 mg 1 0629,0904 +5°C a

Y0001045 Perphenazine for system suitability 1 5 mg 1 0629 Yes +5°C a

Y0000021 Pertussis toxin BRP 1 0.05 mg 2 See leaflet,

1356, 1595,

1931, 1932,

1933, 1934,

2065, 2067,

2329

Yes -20°C g(d)

P0600000 Pethidine hydrochloride - reference spectrum 1 n/a 1 0420 l

P0600002 Pethidine impurity A 1 20 mg 1 1-methyl-4-phenylpiperidine (MPP) 0420 +5°C g

P0800000 Phenazone 2 20 mg 1 0421 +5°C a

Y0001138 Phenazone impurity A 1 20 mg 1 5-methyl-2-phenyl-2,4-dihydro-3§-pyrazol-3-one 0421 +5°C a

P0850000 Pheniramine maleate 2 250 mg 1 1357 +5°C g

Y0001428 Pheniramine impurity A 1 20 mg 1 2-benzylpyridine 1357 +5°C g

P0900000 Phenobarbital - * psy 4 200 mg 1 0189,0201,06

30

+5°C j

Y0001350 Phenobarbital impurity A 1 15 mg 1 0201 Yes +5°C g

Y0001351 Phenobarbital impurity B 1 15 mg 1 0201 +5°C g

P0950000 Phenoxyethanol 4 1 mL 1 Batch 3 is valid until 30 October 2012 0781 +5°C a

P1000000 Phenoxymethylpenicillin 2 250 mg 1 0148 +5°C a

P1100000 Phenoxymethylpenicillin potassium 4 250 mg 1 99.2% CŒÿHŒŸKNœO—S 0113,0114,01

48, 0149

Yes +5°C a

Y0001127 Phentolamine mesilate 1 10 mg 1 1138 +5°C a

Y0001251 Phentolamine mesilate for system suitability 1 10 mg 1 1138 Yes +5°C a

P1109000 Phentolamine mesilate - reference spectrum 1 n/a 1 1138 l

P1150000 Phenylalanine 4 60 mg 1 0782,0796,11

61,2575

+5°C a

P1200000 Phenylbutazone 1 100 mg 1 0422,1574 +5°C g

Y0000147 Phenylbutazone impurity B 1 20 mg 1 (4-butyl-4-hydroxy-1,2-diphenyl-3,5)-pyrazolidinedione 0422 +5°C g

P1240000 Phenylephrine 2 60 mg 1 1035 +5°C a

P1250000 Phenylephrine hydrochloride 3 50 mg 1 0632,1205 +5°C a

Y0000683 Phenylephrine hydrochloride for peak identification 3 2 mg 1 Batch 2 is valid until 31 August 2012 0632,1035 +5°C a

Y0000229 Phenylmercuric acetate - reference spectrum 1 n/a 1 2042 l

P1255100 Phenylmercuric borate - reference spectrum 1 n/a 1 0103 l

P1260000 Phenylpropanolamine hydrochloride - * Drug Precursor 1 50 mg 1 Norephedrin hydrochloride 0683 +5°C i

P1290000 Phenytoin 1 100 mg 1 1253,1988 +5°C a

Y0001167 Phenytoin for system suitability 1 20 mg 1 0521,1253 Yes +5°C a

P1300000 Phenytoin sodium 1 250 mg 1 0521 +5°C a

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Y0000493 Phloroglucinol (anhydrous) 1 210 mg 1 2301,2302 +5°C a

Y0000761 Pholcodine - * narc 1 10 mg 1 0522 +5°C k

Y0000798 Pholcodine for peak identification - * narc 1 10 mg 1 0522 Yes +5°C k

Y0000766 Phthalic acid 1 20 mg 1 benzene-1,2-dicarboxylic acid 2348 +5°C a

P1500000 Phthalylsulfathiazole 1 100 mg 1 0352 +5°C a

P1600000 Physostigmine salicylate 1 100 mg 1 0286 +5°C g

P1605000 Physostigmine sulfate 1 100 mg 1 0684 +5°C f

P1609000 Phytomenadione 3 150 mg 1 87.0% trans-phytomenadione, 12.6% cis-phytomenadione, 0.09% trans- epoxyphytomenadione C–ŒH÷ÿOœ; Vitamin K1

1036 Yes +5°C a

P1609010 trans-Epoxyphytomenadione 2 10 mg 1 1036 +5°C a

P1645000 Picotamide monohydrate 1 125 mg 1 1358 +5°C a

P1645005 Picotamide impurity A 1 25 mg 1 4-methoxybenzene-1,3-dicarboxylic acid 1358 +5°C a

Y0001508 Picrotin 1 40 mg 1 2486 Yes +5°C a

Y0001528 Picrotoxinin 1 40 mg 1 98.3 % CŒ—HŒÿOÿ 2486 Yes +5°C g

Y0000124 Pidolate impurity B 2 60 mg 1 (2S)-2-[[[(2S)-5-oxopyrrolidin-2-yl]carbonyl]amino]pentane-dioic acid 1619 +5°C a

Y0000123 Pidolic acid 1 125 mg 1 1619 +5°C a

P1650000 Pilocarpine hydrochloride 2 50 mg 1 0633 +5°C g

P1700000 Pilocarpine nitrate 1 50 mg 1 0104 +5°C g

Y0000106 Pilocarpine nitrate for system suitability 1 20 mg 1 0104,0633 +5°C g

Y0000525 Pimobendan 1 10 mg 1 2179 +5°C a

Y0000401 Pimobendan for system suitability 1 0.1 mg 1 2179 +5°C a

P1750000 Pimozide 1 150 mg 1 1254 +5°C a

P1800000 Pindolol 1 100 mg 1 0634,0871,17

89

+5°C g

Y0001520 Pioglitazone hydrochloride 1 120 mg 1 99.8% CŒ„HœŒClNœO–S 2601 Yes +5°C a

Y0001519 Pioglitazone for system suitability 1 15 mg 1 2601 Yes +5°C a

Y0001476 Pipemidic acid trihydrate 1 15 mg 1 1473 +5°C a

Y0000061 Pipemidic acid trihydrate - reference spectrum 1 n/a 1 1743 l

P1890000 Piperacillin 3 100 mg 1 94.5% Cœ–HœŸN—OŸS 1168,1169 +5°C a

P1900000 Piperazine adipate 1 250 mg 1 0423 +5°C g

P2000000 Piperazine citrate 1 250 mg 1 0424 +5°C g

P2100000 Piperazine hydrate 1 250 mg 1 0425 +5°C g

Y0001217 Piperine 1 30 mg 1 2477,2453 +5°C g

Y0000288 Piracetam 2 120 mg 1 99.8% CÿHŒÐNœOœ 1733 +5°C a

Y0000038 Pirenzepine dihydrochloride monohydrate 1 250 mg 1 2001 +5°C g

P2120000 Piretanide 1 100 mg 1 1556 +5°C a

Y0001458 Piretanide for system suitability 1 10 mg 1 1556 Yes +5°C a

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P2120002 Piretanide impurity A 1 20 mg 1 4-phenoxy-3(1H-pyrrol-1-yl)-5-sulphamoylbenzoic acid 1556 +5°C a

P2130000 Piroxicam 3 50 mg 1 Batch 2 is valid until 31 January 2013 0944 +5°C g

Y0001475 Piroxicam for system suitability 4 15 mg 1 Y0001475 replaces P2130100 0944 Yes +5°C g

P2150000 Pivampicillin 1 50 mg 2 99.2% CœœHœ„N–OÿS 0808,0852 +5°C a

P2152000 Pivmecillinam hydrochloride 2 100 mg 1 99.6% CœŒH–÷ClN–O—S 1359 -20°C c

P2152015 Pivmecillinam impurity C 2 10 mg 1 methylene 2,2-dimethylpropanoate (2RS,4S)-2-[[[(hexahydo- 1H-azepin-1-yl)methylene]amino]methyl]-5,5-dimethylthiazolidin-4-carboxylate

1359 +5°C a

P2155001 Plastic additive 01 1 2 ml 1 (2RS)-2-ethylhexyl) benzene-1,2-dicarboxylate 90001,90002,

30114

+5°C a

P2155003 Plastic additive 03 1 100 mg 1 N,N'-ethylenedialcanamide 90001,30114 +5°C a

E0800000 Plastic additive 04 1 500 mg 1 Epoxidised soya oil 90001,30114 +5°C a

P2155005 Plastic additive 05 1 500 mg 1 Epoxidised linseed oil 90001,30114 +5°C a

P2155008 Plastic additive 08 3 500 mg 1 ethylene bis[3,3-bis[3-(1,1-dimethylethyl)-4-hydroxyphenyl]butanoate] 30103,30104,

30105,30106

+5°C a

P2155009 Plastic additive 09 3 250 mg 1 pentaerythrityl tetrakis[3-(3,5-di-tert-butyl-4-hydroxyphenyl)propionate] 30103,30105,

30106,30107

Yes +5°C a

P2155010 Plastic additive 10 2 250 mg 1 4,4',4''-(2,4,6-trimethylbenzene-1,3,5-triyltrismethylene)trio[2,6-bis(1,1- dimethylethyl)phenol]

30103,30105,

30106,30107

+5°C a

P2155011 Plastic additive 11 2 500 mg 1 Octadecyl 3-(3,5-di-tert-butyl-4-hydroxyphenyl)-propionate 30103,30105,

30106,30107

+5°C a

P2155012 Plastic additive 12 3 250 mg 1 Tris (2,4-di-1,1-dimethylethylphenyl) phosphite R 30103,30105,

30106,30107

+5°C a

P2155013 Plastic additive 13 2 250 mg 1 1,3,5-tris(3,5-di-1,1-dimethylethyl-4-hydroxybenzyl)-1H,3H,5H-1,3,5- triazine-2,4,6-trione

30103,30105,

30106

+5°C a

P2155014 Plastic additive 14 2 250 mg 1 2,2'-Di(octadecycloxy)-5,5'-spirobi(1,3,2-dioxaphosphorinane) R 30103,30105,

30106

+5°C a

P2155015 Plastic additive 15 2 500 mg 1 Dioctadecyl disulphide ; Batch 1 is valid until 29 August 2012 30103,30104,

30105,30106

+5°C a

P2155016 Plastic additive 16 2 250 mg 1 Didodecyl 3,3'-thiodipropionate R 30103,30105,

30106

+5°C a

P2155017 Plastic additive 17 2 250 mg 1 Dioctadecyl 3,3'-thiodipropionate R 30103,30105,

30106

+5°C a

P2155018 Plastic additive 18 1 100 mg 1 30103 +5°C a

O0140000 Plastic additive 20 1 100 mg 1 Oleamide R 30103,30105,

30106,30107

+5°C a

E1260000 Plastic additive 21 1 100 mg 1 Erucamide R 30103,30107 +5°C a

P2155022 Plastic additive 22 1 100 mg 1 Copolymer of dimethyl butanedioate and 1-(2-hydroxyethyl)-2,2,6,6- tetramethylpiperidin-4-olSynonyms: copolymer of dimethyl succinate and (4-hydroxy-2,2,6,6- tetramethylpiperidin-1-yl)ethanol

30103 +5°C a

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P2155023 Plastic additive 23 1 200 mg 1 di(isooctyl)2,2'-[(dioctylstannylene)bis(thio)]diacetatecontaining about 27% of (tri(isooctyl)2,2',2''- [monooctyl- stannylidyne)tris(thio)] triacetate.Tin-content of 15.4%

30110,30111 +5°C a

P2160000 Poliomyelitis vaccine (inactivated) BRP 2 0.5 ml 5 320-67-282 Ph. Eur. D-Antigen Units per ml for types 1-2-3, respectively 0214,2066,20

65,

2328,2061,20

67,

1934,2329,20

720

Yes -80°C d

P2161000 Poliomyelitis vaccine (oral) BRP 3 1 ml 5 log ŒÐ CCID50/ml for types 1,2,3 and total virus content: 6.99, 6.06, 6.83 and7.20, respectively

See leaflet,

0215

Yes -20°C d

P2163920 Poloxamer 124 1 30 mg 1 1464 +5°C a

P2164009 Poloxamer 188 1 100 mg 1 1464 +5°C a

P2164020 Poloxamer 237 1 100 mg 1 1464 +5°C a

P2164021 Poloxamer 338 1 100 mg 1 1464 +5°C a

P2164030 Poloxamer 407 1 100 mg 1 1464 +5°C a

P2170000 Polyacrylate - reference spectrum 1 n/a 1 0733 l

P2400000 Polymyxin B sulfate 5 25.1 mg 1 65.1% polymyxin B1, 12.5% polymyxin, 3.3% polymyxin B3, 9.1% polymyxinB1-I

0203 Yes +5°C a

Y0000355 Polymyxin B sulfate for microbiological assay 2 25 mg 1 205000 IU per vial 20702 -20°C a

Y0000289 Polysorbate 20 - reference spectrum 1 n/a 1 0426 l




New Y0001557 Poly (vinyl acetate) 1 100 mg 1 1962 +5°C a

Y0000792 Poly(vinyl acetate) dispersion 30 per cent 1 1500 mg 1 2152 +5°C b

New Y0001550 Poly(vinyl alcohol) 1 100 mg 1 1961 +5°C a

P2600000 Poly(vinyl chloride) 1 100 mg 1 90001,90002,

30114

+5°C a

P2649610 Potassium clavulanate - reference spectrum 1 n/a 1 1140 l

Y0001168 Potassium clavulanate impurity G 1 5 mg 1 1653 Yes -20°C g(c)

Y0000315 Potassium hydrogen aspartate hemihydrate 1 50 mg 1 2076 +5°C a

P2650000 Potassium sorbate 2 100 mg 1 Batch 1 is valid until 30 November 2012 0618 +5°C a

Y0001275 Potassium sucrose octasulfate 1 100 mg 1 92.6% CŒœHŒ÷K‡O–—S‡ 1796 Yes +5°C a

P2660000 Povidone 2 50 mg 1 0685 +5°C a

Y0000466 Povidone (iodinated) 1 10 mg 1 1142 +5°C a

Y0001266 Pramipexole dihydrochloride monohydrate 1 5 mg 1 2416 +5°C a

Y0001187 Pramipexole for system suitability 1 15 mg 1 2416 Yes +5°C a

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Y0001267 Pramipexole impurity D 1 5 mg 1 (6R)-6-N-propyl-4,5,6,7-tetrahydro-1,3-benzothiazole-2,6-diamine 2416 +5°C a

Y0000215 Pravastatin sodium - reference spectrum 1 n/a 1 2059 l

Y0000223 Pravastatin impurity A 5 0.1 mg 1 (3R,5R)-3,5-dihydroxy-7-[(1S,2S,6R,8S,8aR)-6-hydroxy-2-methyl-8- [[(2S)-2-methylbutanoyl]oxy]-1,2,6,7,8,8a-hexahydronaphthalen-1-yl] heptanoic acid (6'-epipravastatin)

2059 -20°C c

Y0000204 Pravastatin 1,1,3,3-tetramethylbutylamine 2 30 mg 1 76.4% Cœ–H–ÿOŸ 2059 -20°C c

P2669000 Prazepam -* psy 1 50 mg 1 1466 +5°C j

P2670000 Praziquantel 3 200 mg 1 99.8% CŒ„Hœ÷NœOœ 0855 +5°C a

Y0001533 Praziquantel for system suitability 1 10 mg 1 0855 Yes +5°C a

P2675000 Praziquantel impurity A 2 10 mg 1 (11bRS)-2-benzoyl-1,2,3,6,7,11b-hexahydro-4H-pyrazino[2,1-a]isoquinolin-4-one

0855 +5°C a

P2680000 Prazosin hydrochloride 1 50 mg 1 0856 +5°C a

P2698000 Prednicarbate 2 100 mg 1 99.1% CœŸH–ÿO‡ 1467 +5°C a

Y0001443 Prednicarbate for system suitability 1 10 mg 1 1467 Yes +5°C a

P2700000 Prednisolone 7 150 mg 1 99.2% CœŒHœ‡O—; Prednisolone CRS 6 is suitable for monographs01/2011:0335, 01/2008:0353, 01/2008:0354 and 01/2008:0735 only.

0335,0353,03

54, 0735

Yes +5°C a

Y0001359 Prednisolone for peak identification 1 10 mg 1 0353 Yes +5°C a

Y0001355 Prednisolone for system suitability 1 10 mg 1 0353 Yes +5°C a

P2800000 Prednisolone acetate 4 120 mg 1 Batch 3 is valid until 1 April 2013 0734,0736,09

33,

0975,1467,03

34

+5°C a

Y0000582 Prednisolone acetate for peak identification 1 10 mg 1 0734 Yes +5°C a

P2804000 Prednisolone hexanoate 1 10 mg 1 1212 +5°C a

P2805000 Prednisolone pivalate 1 100 mg 1 0734,0736 +5°C a

P2810000 Prednisolone sodium phosphate 4 100 mg 1 0549,0735,08

10

+5°C a

P2900000 Prednisone 4 100 mg 1 0354 +5°C a

P2920000 Pregnenolone isobutyrate 5 200 mg 1 0993,0593 -20°C a

Y0000263 Prekallikrein activator in albumin BRP 3 1 mL 3 30 IU per vial ; Batch 2 is valid until 30 April 2012 See leaflet,

20615

Yes -20°C b

P2939000 Prilocaine 1 150 mg 1 1362 +5°C a

P2939060 Prilocaine hydrochloride 1 100 mg 1 1363 +5°C a

Y0001408 Prilocaine impurity B 1 80 mg 1 2-methylbenzenamine hydrochloride 1362,1363 +5°C a

P2939025 Prilocaine impurity E 1 25 mg 1 (RS)-N-(methylphenyl)-2-(propylamino)propanamide 1362,1363 +5°C a

P2940000 Primaquine diphosphate 2 500 mg 1 0635 +5°C g

P2950000 Primidone 2 150 mg 1 99.9% CŒœHŒ÷NœOœ ; Batch 1 is valid until 31 May 2012 0584 Yes +5°C a

Y0000369 Primidone for peak identification 1 5 mg 1 0584 Yes +5°C a

P3000000 Probenecid 1 100 mg 1 0243 +5°C a

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P3050000 Procainamide hydrochloride 1 100 mg 1 0567 +5°C a

P3090000 Procaine benzylpenicillin 2 250 mg 1 39.7% CŒ–HœÐNœOœ (procaine); 96.3% Cœ„H–‡N÷OÿS 0115 +5°C a

P3100000 Procaine hydrochloride 1 100 mg 1 0050 +5°C g

P3200000 Prochlorperazine maleate 1 100 mg 1 0244,20303 +5°C a

P3300000 Progesterone 2 50 mg 1 0429 +5°C a

Y0000148 Progesterone impurity C 1 10 mg 1 (20R)-20-hydroxypregn-4-en-3-one 0429 +5°C a

Y0000179 Proguanil hydrochloride - reference spectrum 1 n/a 1 2002 l

Y0000181 Proguanil impurity C 2 10 mg 1 1,5-bis(4-chlorophenyl)biguanide 2002 +5°C g

Y0000182 Proguanil impurity D 2 10 mg 1 1,5-bis(1-methylethyl)biguanide 2002 +5°C g

P3350000 Proline 3 60 mg 1 Batch 2 is valid until 1 April 2013 0785,0910,09

11, 1049

+5°C a

P3390000 Promazine hydrochloride 1 100 mg 1 0475,1365,20

303

+5°C g

P3400000 Promethazine hydrochloride 2 50 mg 1 0524 +5°C g

Y0000769 Promethazine impurity D 1 10 mg 1 (2RS)-N,N-dimethyl-1-(10H-phenothiazin-10-yl)propan-2-amine S-oxide 0524 +5°C g

Y0000797 Promethazine for peak identification 1 10 mg 1 0524 Yes +5°C g

P3490000 Propacetamol hydrochloride - reference spectrum 1 n/a 1 1366 l

Y0000455 Propafenone hydrochloride 1 10 mg 1 2103 +5°C a

Y0000456 Propafenone impurity B 1 10 mg 1 (2E)-1-[2-[(2RS)-2-hydroxy-3-(propylamino)propoxy]phenyl]-3- phenylprop-2-en-1-one

2103 +5°C a

Y0000278 Propanol - reference spectrum 1 n/a 1 2036 l

Y0000016 Propofol 5 370 mg 1 99.8% CŒœHŒ‡O ; Batch 4 is valid until 1 May 2013 1558 Yes +5°C g

Y0000017 Propofol for peak identification 3 0.1 ml 1 1558 +5°C g

Y0000018 Propofol impurity J 3 20 mg 1 2,6-bis (1-methylethyl)-1,4-benzoquinone 1558 +5°C g

P3500000 Propranolol hydrochloride 2 30 mg 1 0568,0923 +5°C g

P3600000 Propranolol hydrochloride for performance test 3 20 mg 1 0568 Yes +5°C g

New Y0001547 Propylene glycol 1 150 mL 1 2645 +5°C a

Y0000318 Propylene glycol dilaurate 1 100 mg 1 2087 +5°C a

Y0000319 Propylene glycol monolaurate 1 100 mg 1 1915 +5°C a

P3640000 Propyl gallate 2 50 mg 1 1039 +5°C a

P3650000 Propyl parahydroxybenzoate 3 150 mg 1 99.9% CŒÐHŒœO– 0431,0852,12

63

+5°C a

P3700000 Propylthiouracil 1 100 mg 1 0525 +5°C a

P3750000 Propyphenazone 4 200 mg 1 0636 +5°C a

P3760000 Protirelin 3 5.03 mg 2 5.03 mg per vial of pure protirelin peptide CŒÿHœœNÿO÷ 1144 -20°C c

P3760020 D-His-Protirelin 2 0.1 mg 1 approx. 0.1 mg per vial 1144 -20°C c

P3800000 Proxyphylline 1 100 mg 1 0526 +5°C a

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P3850000 Pseudoephedrine hydrochloride - * Drug Precursor 3 50 mg 1 Batch 2 is valid until 31 October 2012 0487,1367 +5°C i

Y0000387 Pseudoisoeugenyl 2-methylbutyrate for peak identificatio 1 100 mg 1 Star anise oil 2108 Yes +5°C a

Y0001537 Purified quillaia saponins 1 30 mg 1 1843 -20°C c

P3900000 Purpureaglycoside A 1 25 mg 1 0117 +5°C a

P4000000 Purpureaglycoside B 1 25 mg 1 0117 +5°C a

Y0000402 Pyrantel embonate 1 10 mg 1 1680 +5°C a

Y0000403 Pyrantel impurity A 1 20 mg 1 1-methyl-2-[(Z)-2-(thiophen-2-yl)ethenyl]-1,4,5,6-tetrahydropyrimidine 1680 +5°C a

P4050000 Pyrazinamide 2 30 mg 1 0859 +5°C a

P4099900 Pyridostigmine bromide 3 30 mg 1 1255 +5°C g

P4099910 Pyridostigmine impurity A 1 20 mg 1 pyridin-3-yl-dimethylcarbamate 1255 +5°C g

Y0001486 Pyridostigmine impurity B 1 10 mg 1 3-hydroxy-1-methylpyridinium 1255 +5°C g

P4100000 Pyridoxine hydrochloride 1 100 mg 1 0245 +5°C a

Y0001226 Pyridoxine impurity A 2 5 mg 1 6-methyl-1,3-dihydrofuro[3,4-c]pyridin-7-ol 0245 +5°C a

P4200000 Pyrimethamine 1 250 mg 1 0288 +5°C g

Y0000659 Pyrrolidone 1 20 mg 1 2180 +5°C a

New Y0001009 Quercetin dihydrate 2 25 mg 1 90.5% CŒ—HŒÐOŸ ; Batch 1 is valid until 31 August 2013 1827 Yes +5°C g

New Y0001564 Quillaia saponin assay 1 30 mg 1 64.9 % C÷œHÿ—NOŒÿ; monoammonium glycyrrhizate 1843 Yes +5°C a

Y0001491 Quinapril hydrochloride 1 30 mg 1 1763 +5°C a

Y0001502 Quinapril for peak identification 1 5.075 mg 1 1763 Yes +5°C a

Y0001503 Quinapril for system suitability 1 5.125 mg 1 1763 Yes +5°C a

Q0100000 Quinidine sulfate 1 300 mg 1 0017,0018,00

19

+5°C a

Q0200000 Quinine sulfate 2 300 mg 1 0017,0018,00

19

+5°C a

R0100000 Rabies vaccine (inactivated) for veterinary use BRP 4 86 mg 3 11 IU per vial See leaflet,

0451

Yes -20°C c

Y0000896 Racecadotril 1 110 mg 1 99.9% CœŒHœ–NO÷S 2171 +5°C a

Y0000897 Racecadotril impurity A 2 1.1 mL 1 92,8% CH–COSH; ethanethioic acid ; Batch 1 is valid until 1 July 2013 2171 Yes +5°C g

Y0000898 Racecadotril impurity G 1 10 mg 1 benzyl [[(2RS)-2-benzyl-3-sulfanylpropanoyl]amino]acetate 2171 +5°C a

Y0000902 Racecadotril for peak identification 1 5 mg 1 2171 Yes +5°C a

Y0001134 Raloxifene hydrochloride 1 110 mg 1 99.7% Cœ‡Hœ‡ClNO÷S 2375 +5°C g

Y0001135 Raloxifene hydrochloride for peak identification 1 10 mg 1 2375 Yes +5°C g

R0145000 Ramipril 2 20 mg 1 1368 +5°C a

R0145005 Ramipril impurity A 3 10 mg 1 (2S,3aS,6aS)-1-[(S)-2-[[(S)-1-(methoxycarbonyl)-3- phenylpropyl]amino] propanoyl]octahydrocyclopenta[b]pyrrole-2-carboxylic acid (ramipril methylester)

1368 +5°C a

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R0145010 Ramipril impurity B 3 10 mg 1 (2S,3aS,6aS)-1-[(S)-2-[[(S)-1-[(methylethoxy)carbonyl]-3- phenylpropyl] amino]propanoyl]octahydrocyclopenta[b]pyrrole- 2-carboxylic acid (ramipril isopropyl ester)

1368 +5°C a

R0145015 Ramipril impurity C 3 10 mg 1 (2S,3aS,6aS)-1-[(S)-2-[[(S)-1-(ethoxycarbonyl)-3-cyclohexylpropyl]amino] propanoyl]octahydrocyclopenta[b]pyrrole-2- carboxylic acid (hexahydroramipril)

1368 +5°C a

R0145020 Ramipril impurity D 4 10 mg 1 ethyl (2S)-2-[(3S,5aS,8aS,9aS)-3-methyl-1,4-dioxodecahydro -1H- cyclopenta[e]pyrrolo[1,2a]pyrazin-2-yl]-4-phenylbutanoate (ramipril

1368 +5°C a

R0150000 Ranitidine hydrochloride 3 100 mg 1 0946,1453 +5°C a

Y0000416 Ranitidine impurity J 5 0.00025 mg 1 1,1'-N-[methylenebis(sulphanediylethylene)]bis(N'-methyl-2-nitroethene-1,1- diamine)

0946 -20°C c

Y0000411 Ranitidine for system suitability 2 20 mg 1 0946 Yes +5°C a

Y0000457 Repaglinide 1 20 mg 1 2135 +5°C a

Y0000458 Repaglinide for system suitability 2 6 mg 1 2135 Yes +5°C a

Y0000459 Repaglinide impurity E 2 10 mg 1 2-ethoxy-4-[2-[[(1R)-3-methyl-1-[2-(piperidin-1-yl)phenyl]butyl]amino]-2- oxoethyl]benzoic acid

2135 +5°C a

R0200000 Reserpine 3 100 mg 1 99.8% C––H÷ÐNœO„ 0528 +5°C a

R0250000 Residual solvents solution class 1 4 1.4 mL 1 Batch 3 is valid until 30 April 2012 20424 Yes +5°C g

Y0000767 Resorcinol 1 20 mg 1 benzene-1,3-diol 2348 +5°C g

R0300000 Retinol acetate 6 1000 mg 1 1 050 000 IU per g 0218,0219,02

20, 1192,1193

Yes -20°C c

R0290000 Retinol esters 1 100 mg 1 0217,0218,02

19, 0220

+5°C a

R0500500 Reviparin sodium 1 250 mg 1 0828 +5°C a

Y0000377 Ribavirin 2 150 mg 2 99.9% C‡HŒœN÷O— ; Batch 1 is valid until 31 May 2012 2109 Yes +5°C a

New R0600000 Riboflavin 4 130 mg 1 Vitamin B2 ; Batch 3 is valid until 31 August 2013 0292,0786 +5°C a

Y0000757 Riboflavin for peak identification 3 0.12 mg 1 Batch 2 is valid until 31 October 2012 0292 Yes +5°C a

R0630000 Riboflavin sodium phosphate 2 250 mg 1 0786 +5°C a

Y0000662 Ribonucleic acid 1 100 mg 1 100.0 % 2090 +5°C a

Y0000149 Rifabutin 2 150 mg 1 95.5% C÷—HÿœN÷OŒŒ 1657 +5°C a

Y0000184 Rifabutin impurity A 1 20 mg 1 1-(2-methylpropyl)piperidin-4-one 1657 +5°C a

R0700000 Rifampicin 2 100 mg 1 0052 +5°C a

R0800000 Rifampicin quinone 4 100 mg 1 0052 +5°C a

R0900000 Rifamycin B 2 50 mg 1 Rifamycin impurity A 0432 +5°C a

R0950000 Rifamycin S 2 50 mg 1 0432 +5°C a

R1000000 Rifamycin sodium 3 300 mg 1 856 IU per mg 0432,20702 -20°C c

Y0001074 Rifaximin 1 160 mg 1 98.0% C÷–H—ŒN–OŒŒ 2362 +5°C a

Y0001075 Rifaximin for system suitability 1 10 mg 1 2362 Yes +5°C a

Y0000250 Rilmenidine dihydrogenophosphate - reference spectrum 1 n/a 1 2020 l

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Y0000187 Rilmenidine for system suitability 1 30 mg 1 2020 +5°C g

New Y0001541 Risedronate sodium 2.5-hydrate 1 15 mg 1 2572 +5°C a

New Y0001558 Risedronate impurity A 1 15 mg 1 78.4 % 2572 Yes +5°C a

New Y0001540 Risedronate impurity E 1 15 mg 1 2-(pyridin-3-yl)ethane-1,1-diyl]bis(phosphonic acid) 2572 +5°C a

R1000600 Risperidone 2 50 mg 1 1559 +5°C g

Y0000370 Risperidone for system suitability 4 20 mg 1 1559 Yes +5°C g

Y0001276 Risperidone impurity K 1 0.015 mg 1 3-[2-[4-(1,2-benzisoxazol-3-yl)piperidin-1-yl]ethyl]-2-methyl-6,7,8,9- tetrahydro-4Hpyrido[1,2-a]pyrimidin-4-one (desfluoro risperidone)

1559 +5°C g

Y0000714 Ritonavir 1 80 mg 1 99.6% C–ŸH÷‡NÿO—Sœ 2136 +5°C a

Y0000706 Ritonavir for peak identification 1 10 mg 1 2136 Yes +5°C a

Y0001516 Rivastigmine hydrogen tartrate 1 350 mg 1 99.9% CŒ‡Hœ‡NœO‡ 2629,2630 Yes +5°C g

Y0001485 Rivastigmine for system suitability 1 1.0114 mg 1 2629,2630 Yes +5°C g

Y0001515 Rivastigmine impurity D 1 10 mg 1 3-[(1R)-1-(dimethylamino)ethyl]phenyl ethyl(methyl)carbamate ((R)- enantiomer)

2629,2630 Yes +5°C g

Y0001302 Rizatriptan benzoate 1 200 mg 1 2585 Yes +5°C a

Y0001303 Rizatriptan for system suitability 1 15 mg 1 2585 Yes +5°C a

R1300000 RK 13 cells 1 1 ml 2 cell lines (kidney, rabbit) titration of live measles, mumps and rubella vaccines 0162,1057 Yes Liquid

nitrogen

d

Y0000594 Rocuronium bromide - reference spectrum 1 n/a 1 1764 l

Y0000527 Rocuronium for peak identification 1 10 mg 1 1764 Yes -20°C g(c)

Y0000742 Ropivacaine hydrochloride monohydrate 1 10 mg 1 2335 +5°C a

Y0000743 Ropivacaine impurity G 1 5 mg 1 (+)-(2R)-N-(2,6-dimethylphenyl)-1-propylpiperidine-2-carboxamide ((R)- ropivacaine)

2335 +5°C a

Y0000786 Rosmarinic acid 2 50 mg 1 Batch 1 is valid until 28 February 2013 1447,2382,

2524

Yes +5°C a

R1500000 Roxithromycin 5 125 mg 1 96.7% C÷ŒHŸÿNœOŒ— 1146 +5°C a

Y0000220 Roxithromycin for system suitability 2 5 mg 1 1146 +5°C a

R2000000 Rubella vaccine (live) BRP 1 90 mg 1 3.6 logŒÐ (ie 4000) infective viral units per vial 1057,0162 Yes -80°C d

Y0000494 Ruscogenins 1 10 mg 1 38.2% ruscogenin60.4% neoruscogenin

1847 Yes +5°C a

S0040000 Saccharin 1 30 mg 1 0947 +5°C a

S0050000 Saccharin sodium 1 50 mg 1 0787 +5°C a

S0100000 Salbutamol 2 50 mg 1 0529,1033 +5°C a

New Y0000030 Salbutamol impurity B 5 10 mg 1 (1RS)-2-[(1,1-dimethylethyl)amino]-1-(4-hydroxyphenyl)ethanol 0529 +5°C a

Y0000071 Salbutamol impurity D 5 10 mg 1 5-[(1RS)-2-[(1,1-dimethylethyl)amino]-1-hydroxyethyl]-2- hydroxybenzaldehyde ; Batch 4 is valid until 31 January 2013

0529,0687 Yes +5°C a

Y0000031 Salbutamol impurity F 4 10 mg 1 93.4% CœÿH÷ÐNœO— x HœSO÷; 1,1'-[oxybis[methylene(4-hydroxy-1,3- phenylene)]]bis[2-[(1,1- dimethylethyl)amino]ethanol]

0529,0687 Yes +5°C a

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Y0000034 Salbutamol impurity G 3 5 mg 1 2-[benzyl(1,1-dimethylethyl)amino]-1-[4-hydroxy-3-(hydroxymethyl)phenyl]ethanone

0529 +5°C a

Y0000032 Salbutamol impurity I 4 0.006 mg 1 (1RS)-2-[(1,1-dimethylethyl)amino]-1-[3-(hydroxymethyl)-4- benzyloxyphenyl]ethanol

0529 +5°C a

New Y0001186 Salbutamol impurity J 2 0.00045 mg 1 Batch 1 is valid until 31 August 2013 0687 +5°C a

S0150000 Salbutamol sulfate 2 50 mg 1 0687 +5°C a

Y0001288 Salbutamol sulfate for system suitability 1 10 mg 1 0687 Yes +5°C a

Y0000669 Salicin 1 50 mg 1 99,6% CŒ–HŒ‡OŸ 2312,1583 +5°C a

S0200000 Salicylic acid 2 100 mg 1 0366,1185 +5°C a

Y0000405 Salicylic acid impurity B 1 10 mg 1 4-hydroxyisophthalic acid 0366 +5°C a

Y0000422 Salmeterol xinafoate 2 50 mg 1 99.6% C–ÿH÷—NOŸ ; Batch 1 is valid until 30 April 2012 1765 Yes +5°C a

Y0000423 Salmeterol xinafoate for system suitability 1 25 mg 1 1765 Yes +5°C a

Y0001559 Salvianolic acid B 1 15 mg 1 92.2 % C–ÿH–ÐOŒÿ 2663 Yes +5°C a

Y0001052 Santonin 1 20 mg 1 99.8% CŒ—HŒ‡O– 1391,1809 +5°C a

Y0001049 Saquinavir mesilate 1 70 mg 1 99.5% C–„H—÷NÿO‡S 2267 +5°C a

Y0001056 Saquinavir for system suitability 1 0.3033 mg 1 2267 Yes +5°C a

Y0001483 Saw palmetto extract HRS 1 8000 mg 1 2579 Yes 0 a

Y0000814 Selamectin 1 100 mg 1 97.6% C÷–Hÿ–NOŒŒ 2268 +5°C g

Y0000815 Selamectin for system suitability 1 5 mg 1 2268 Yes +5°C g

S0360000 Selegiline hydrochloride 1 50 mg 2 1260 +5°C g

S0360090 (RS)-Selegiline hydrochloride 2 25 mg 1 Batch 1 is valid until 31 October 2012 1260 +5°C g

S0400000 Senna extract 1 50 mg 1 0206,0207,02

08, 1261

-20°C c

S0450000 Serine 1 50 mg 1 0788,1027 +5°C a

S0460000 Sertaconazole nitrate 2 125 mg 1 Batch 1 is valid until 30 September 2012 1148 +5°C a

Y0000828 Sertraline hydrochloride 2 200 mg 1 99.9% CŒŸHŒ‡Cl–N 1705 Yes +5°C g

Y0001285 Sertraline impurity E 1 15 mg 1 Mandelic acid CRS has been labelled as sertraline impurity E CRS in anticipation of 01/2011:1705 corrected 7.1

1705 Yes +5°C a

New Y0000866 Sertraline for peak identification 3 5.4 mg 1 Batch 2 is valid until 30 September 2013 1705 Yes +5°C g

Y0000867 Sertraline for system suitability 2 6.18 mg 1 1705 +5°C g

Y0000371 Sestamibi labelling kit 2 22 mg 1 1926 Yes +5°C a

Y0001046 Sevoflurane 1 1 ml 1 2269 Yes +5°C g(b)

Y0001578 Sildenafil citrate 1 100 mg 1 98.8 % Cœ‡H–‡NÿOŒŒS 2270 Yes +5°C a

Y0001579 Sildenafil impurity A 1 10 mg 1 5-[2-ethoxy-5[(4-methylpiperazin-1-yl)sulfonyl]phenyl]-1-methyl-3-(2- methylpropyl)-6,7-dihydro-1H-pyrazol[4,3-d]pyrimidin-7-one

2270 +5°C a

S0500000 Silicone elastomer 2 2000 mg 1 30109 +5°C a

S0600000 Silicone oil 1 1 ml 1 30108 +5°C a

S0650000 Simvastatin 4 100 mg 1 99.4% Cœ—H–‡O— 1538,1563 Yes -20°C g(c)

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Y0001066 Simvastatin for peak identification 1 10 mg 1 1563 Yes -20°C g(c)

Y0001208 Sinomenine 1 20 mg 1 81.8 % CŒ„Hœ–NO÷ 2450 Yes +5°C a

S0660000 Sisomicin sulfate 2 60 mg 1 77.7% C–‡H‡÷NŒÐO–÷S— 0331, 1351 Yes -20°C a

Y0000014 Sodium alendronate 3 150 mg 1 83.3% C÷HŒœNNaOŸPœ 1564 +5°C a

S0695000 Sodium amidotrizoate 1 125 mg 1 1150 +5°C a

Y0000300 Sodium aminosalicylate dihydrate - reference spectrum 1 n/a 1 1993 l

Y0000039 Sodium ascorbate 1 50 mg 1 1791 +5°C a

S0700000 Sodium calcium edetate 1 100 mg 1 0231 +5°C a

S0710000 Sodium cetostearyl sulfate 1 100 mg 1 0847 +5°C a

S0750000 Sodium cromoglicate 2 10 mg 1 0562 +5°C a

Y0001300 Sodium cromoglicate for system suitability 1 20 mg 1 0562 +5°C a

S0760000 Sodium cyclamate 2 100 mg 1 0774 +5°C a

S0765000 Diclofenac sodium 3 100 mg 1 1002,1281 +5°C g

Y0001410 Sodium fusidate 1 10 mg 1 0848 +5°C b

S0781000 Sodium hyaluronate - reference spectrum 1 n/a 1 1472 l

S0780000 Sodium hyaluronate BRP 2 300 mg 1 0912 +5°C a

Y0001468 Sodium iodohippurate 1 15 mg 1 2352 +5°C a

Y0000620 Sodium laurilsulfate 1 40 mg 1 0802 +5°C g

Y0000808 Sodium phenylbutyrate 1 5 mg 1 2183 +5°C a

Y0000809 Sodium phenylbutyrate impurity C 1 10 mg 1 4-cyclohexylbutanoic acid 2183 +5°C a

S0785000 Sodium picosulfate 1 100 mg 1 1031 +5°C a

Y0001104 Picosulfate for system suitability 1 0.5 mg 1 1031 Yes +5°C a

Y0000210 Sodium polystyrene sulfonate - reference spectrum 1 n/a 1 1909 l

Y0000268 Sodium propionate - reference spectrum 1 n/a 1 2041 l

S0800000 Sodium salicylate 1 100 mg 1 0413 +5°C a

S0808000 Sodium stearyl fumarate 1 50 mg 1 1567 +5°C a

S0808060 Sodium stearyl maleate 2 10 mg 1 1567 +5°C a

S0900000 Sodium taurocholate BRP 2 10000 mg 1 0350 +5°C a

S0930000 Sodium valproate 4 150 mg 1 0678 +5°C a

S0945000 Somatostatin 5 2.32 mg 1 2.32mg somatostatin peptide per vial CŸÿHŒÐ÷NŒ‡OŒ„Sœ 0949 -20°C c

S0947000 Somatropin 3 55 mg 1 3.86 mg somatropin monomer per vial ; Batch 2 is valid until 31 August 2012 See leaflet,

0950,

0951,0952

Yes -20°C c

Y0000711 Somatropin/desamidosomatropin resolution mixture 1 33 mg 1 1.7 mg somatropin per vial 0950,0951,09

52

Yes -20°C c

S0950000 Sorbic acid 2 10 mg 1 0592 +5°C a

Y0000385 1,4-Sorbitan 2 50 mg 1 99,7% CÿHŒœO— ; Batch 1 is valid until 1 April 2013 2048 Yes +5°C a

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S1000000 Sorbitol 3 1200 mg 1 97.9 % CÿHŒ÷Oÿ 0435,0436,04

37,

1235,1236,13

37,

1381,1531,20

48

Yes +5°C a

Y0000114 Sotalol hydrochloride 1 25 mg 1 2004 +5°C a

Y0000115 Sotalol impurity B 1 20 mg 1 N-[4-[[(1-methylethyl)amino]acetyl]phenyl]methanesulphonamide 2004 +5°C a

Y0001011 Spanish sage oil for peak identification 1 250 mg 1 1849 Yes +5°C g

Y0000597 Spectinomycin hydrochloride 2 100 mg 1 81.3% CŒ÷HœÿClœNœOŸ and CŒ÷Hœ‡ClœNœOŸ 1152 -20°C a

Y0000549 Spectinomycin for system suitability 1 20 mg 1 1152 Yes -20°C a

Y0000655 Spectinomycin sulfate tetrahydrate 1 10 mg 1 1658 -20°C c

Y0001126 Spike lavender oil 1 400 µl 1 2419 Yes +5°C g

S1100000 Spiramycin 5 200 mg 1 4500 IU per mgSpiramycin I: 87.3%, Spiramycin II: 0.2%, Spiramycin III: 4.4%

0179,0293,19

82,20702

Yes -20°C a

Y0000381 Spirapril hydrochloride monohydrate 1 60 mg 1 95.9% CœœH–ŒClNœO—Sœ 1766 +5°C a

Y0000332 Spirapril for system suitability 1 15 mg 1 1766 +5°C a

S1200000 Spironolactone 3 150 mg 1 99.6% Cœ÷H–œO÷S; Spironolactone CRS 2 is suitable for monograph01/2008:0688 only.

0688 Yes +5°C a

Y0001295 Spironolactone for system suitability 1 2.055 mg 1 0688 Yes +5°C a

Y0000185 Squalane 1 250 µl 1 99.7% C–ÐHÿœ 1630 +5°C a

Y0001050 St. John's wort standardised dry extract 1 500 mg 1 0.050% of hypericin; St. John's wort standardised dry extract CRS has been renamed as St. John's wort dry extract HRS in 01/2013:1874

1874 Yes -20°C c

Y0001091 Standardised artichoke leaf dry extract 1 60 mg 1 2389 Yes -20°C c

S1250000 Stanozolol 2 50 mg 1 Batch 1 is valid until 30 October 2012 1568 +5°C a

S1250010 Stanozolol impurity A 1 10 mg 1 (5¶,17ß)-17-hydroxy-17-methylandrostan-3-one 1568 +5°C a

Y0001420 Stanozolol impurity B 1 10 mg 1 1568 +5°C a

S1300000 Starch BRP 4 50000 mg 1 0350 +5°C a

Y0000408 Stavudine 1 100 mg 1 99.6% CŒÐHŒœNœO÷ 2130 +5°C a

Y0000421 Stavudine for system suitability 1 10 mg 1 2130 Yes +5°C a

S1340000 Stearic acid 3 100 mg 1 Plastic additive 19 0882,1474,16

63,

2058,30103,

30105,

+5°C a

S1350000 Stearyl alcohol 2 250 mg 1 99.5% CŒ‡H–‡O ; Batch 1 is valid until 30 September 2012 0702,0753,08

01,

0802,0847,09

69,

1123,1340,14

11

Yes +5°C a

Y0000868 Streptokinase for system suitability 1 30 µl 1 0356 Yes -20°C c

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S1400000 Streptomycin sulfate 4 100 mg 1 77 000 IU per vial 0032,0033,00

53,

Yes -20°C a

S1500000 Succinylsulfathiazole 1 100 mg 1 0357 +5°C a

Y0001324 Sucralfate 1 10 mg 1 1796 +5°C a

Y0001344 Sucralose 1 550 mg 1 2368 Yes +5°C a

Y0001342 Sucralose impurity B 1 0.5 mg 1 1,6-dichloro-1,6-dideoxy-?-D-fructofuranosyl 6-chloro-6-deoxy-?-D- glucopyranoside (1',6,6'-trichloro-1',6,6'-trideoxysucrose)

2368 +5°C a

S1600000 Sucrose 1 100 mg 1 0177,0178,01

87,

0188,0204,02

09,

1061,1570,23

18

+5°C a

S1608100 Sufentanil - reference spectrum 1 n/a 1 1569 l

S1609000 Sufentanil citrate - reference spectrum 1 n/a 1 1269 l

Y0000529 Sulbactam sodium 1 10 mg 1 2209 +5°C a

Y0000528 Sulbactam 1 150 mg 1 99.7% C‡HŒŒNO—S 2209 Yes -20°C c

Y0000550 Sulbactam for peak identification 1 20 mg 1 2209 Yes +5°C a

S1700000 Sulfacetamide sodium 1 50 mg 1 0107,0295 +5°C a

S1800000 Sulfadiazine 1 100 mg 1 0294 +5°C a

Y0001480 Sulfadiazine for identification of impurity F 1 15 mg 1 0294 +5°C a

Y0001469 Sulfadiazine impurity A 1 20 mg 1 pyrimidin-2-amine 0294 +5°C a

S1900000 Sulfadimidine 1 100 mg 1 0295 +5°C a

Y0001495 Sulfadimidine for peak identification 1 50 mg 1 0295 Yes +5°C a

S1950000 Sulfadoxine 2 50 mg 1 0740 +5°C g

S1975000 Sulfafurazole 1 100 mg 1 0741 +5°C a

New S1975600 Sulfaguanidine 2 60 mg 1 Batch 1 is valid until 31 August 2013 1476, 0295 +5°C a

S2000000 Sulfamerazine 1 100 mg 1 0358,1571 +5°C a

S2050000 Sulfamethizole 1 100 mg 1 0637 +5°C a

S2100000 Sulfamethoxazole 1 50 mg 1 0108 +5°C a

Y0000412 Sulfamethoxazole impurity A 1 5 mg 1 N-(4-(5-methyl)-isoxazol-3-ylsulphamoyl)phenylacetamide 0108 +5°C a

Y0000413 Sulfamethoxazole impurity F 2 5 mg 1 4-amino-N-(3-methylisoxazol-5-yl)benznesulphonamide 0108 +5°C a

S2150000 Sulfamethoxypyridazine 1 50 mg 1 0638 +5°C a

S2151000 Sulfanilamide 1 100 mg 1 1571 +5°C a

S2159100 Sulfapyridine 1 20 mg 1 0863 +5°C a

S2155000 Sulfasalazine 4 250 mg 2 98.1 % CŒ‡HŒ÷N÷O—S ; Batch 3 is valid until 28 February 2013 0863,1457 Yes +5°C a

S2155010 Sulfasalazine derivative for resolution 1 20 mg 1 2-hydroxy-5-[[4-[[(6-methylpyridin-2-yl)amino]-sulfonyl]phenyl]azo]benzoic acid

0863 +5°C a

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S2158000 Sulfathiazole 1 100 mg 1 0742 +5°C a

S2159000 Sulfinpyrazone 1 30 mg 1 0790 +5°C a

Y0001238 Sulfinpyrazone for system suitability 1 0.5 mg 1 0790 Yes +5°C a

S2159010 Sulfinpyrazone impurity A 3 20 mg 1 1,2-diphenyl-4-[2-(phenylsulphonyl)ethyl]pyrazolidine-3,5-dione 0790 +5°C a

S2159015 Sulfinpyrazone impurity B 3 20 mg 1 1,2-diphenyl-4-(2-phenylthioethyl)pyrazolidine-3,5-dione 0790 +5°C a

S2160000 Sulfisomidine 1 50 mg 1 0639 +5°C a

S2180000 Sulindac 3 50 mg 1 Contains 0.3% m/m of E-isomer 0864 +5°C g

S2190000 Sulpiride 4 100 mg 1 Batch 3 is valid until 31 January 2013 1045,1348 +5°C a

S2191000 Sulpiride impurity A 3 20 mg 1 [(2RS)-1-ethylpyrrolidin-2-yl]methanamine 1045,1490 +5°C g

S2192000 Sulpiride impurity B 2 20 mg 1 methyl 2-methoxy-5-sulphamoylbenzoate 1045 +5°C a

Y0000530 Sultamicillin 1 10 mg 1 2211 +5°C a

Y0000531 Sultamicillin tosilate 2 200 mg 1 92.5% C–œH–‡N÷OŒœS– 2211,2212 Yes +5°C a

Y0000532 Sultamicillin for peak identification 1 10 mg 1 2211 Yes +5°C a

Y0000022 Sumatriptan succinate 1 50 mg 1 98.8% CŒ‡HœŸN–OÿS 1573 -20°C c

Y0000026 Sumatriptan impurity mixture 7 3 mg 1 Batch 6 is valid until 31 August 2012 1573 Yes -20°C c

New Y0000027 Sumatriptan for system suitability 5 2.56 mg 1 Batch 4 is valid until 31 August 2013 1573 Yes -20°C c

S2200000 Suxamethonium chloride 1 1000 mg 1 0248 +5°C g

S2400000 Suxibuzone 1 50 mg 1 1574 +5°C a

S2400004 Suxibuzone impurity B 1 10 mg 1 (4-butyl-3,5-dioxo-1,2-diphenylpyrazolidin-4-yl)methyl ethyl butanedioate 1574 +5°C a

S2400006 Suxibuzone impurity C 1 10 mg 1 4-butyl-4-(hydroxymethyl)-1,2-diphenyl-1,2-dihydro-4H-pyrazole-3,5-dione 1574 +5°C a

S5000001 Swine erysipelas bacteria, serotyp 1 (for vaccines - vet. use) BRP 1 1 mg 1 6.5 x10Ì Cfu per vial See leaflet,

0064

Yes +5°C e(b)

S5000002 Swine erysipelas bacteria, serotyp 2 (for vaccines - vet. use) BRP 1 1 mg 1 2.6 x10Ï Cfu per vial See leaflet,

0064

Yes +5°C e(b)

Y0001417 Tadalafil 1 200 mg 1 99.9% CœœHŒ„N–O÷ 2606 Yes +5°C a

T0010000 Talampicillin hydrochloride 1 50 mg 1 0808,0852 +5°C a

T0014000 Tamoxifen citrate 2 80 mg 1 1046 +5°C g

T0015000 Tamoxifen citrate for performance test 3 30 mg 1 1046 Yes +5°C g

Y0000650 Tamsulosin hydrochloride 1 10 mg 1 2131 +5°C a

Y0000653 Tamsulosin racemate 1 10 mg 1 2131 +5°C a

Y0000651 Tamsulosin impurity D 2 10 mg 1 2-methoxy-5-[(2R)-2-[[2-(2-methoxyphenoxy)ethyl]amino]propyl]benzenesulfonamide ; Batch 1 is valid until 1 June 2013

2131 +5°C a

Y0000652 Tamsulosin impurity H 2 10 mg 1 (2R)-N-[2-(2-ethoxyphenoxy)ethyl]-1-(4-methoxyphenyl)propan-2-amine ; Batch 1 is valid until 1 June 2013

2131 +5°C a

Y0001102 Teicoplanin 1 52 mg 1 51550 IU per ampoule 2358 -20°C a

Y0001560 Tanshinone IIa 1 15 mg 1 98.4 % CŒ„HŒ‡O– 2663 Yes +5°C a

Y0001047 Teicoplanin for identification 1 40 mg 1 2358 Yes -20°C a

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Y0000648 Telmisartan 1 30 mg 1 2154 +5°C g

Y0000649 Telmisartan for peak identification 2 10 mg 1 Batch 1 is valid until 31 January 2013 2154 Yes +5°C g

Y0001003 Telmisartan for system suitability 3 0.26 mg 1 Batch 2 is valid until 1 April 2013 2154 Yes +5°C g

T0040000 Temazepam - * psy 1 50 mg 1 0954 +5°C j

Y0000344 Temazepam impurity C 1 5 mg 1 (3RS)-7-chloro-1-methyl-2-oxo-5-phenyl-2,3-dihydro-1H-1,4- benzodiazepin-3-yl acetate

0954 +5°C a

Y0000345 Temazepam impurity D 1 5 mg 1 (3RS)-7-chloro-3-methoxy-1-methyl-5-phenyl-1,3-dihydro-2H-1,4- benzodiazepin-2-one

0954 +5°C a

Y0000346 Temazepam impurity F 1 5 mg 1 (5RS)-7-chloro-1-methyl-5-phenyl-4,5-dihydro-1H-1,4-benzodiazepine-2,3- dione 0954 +5°C a

Y0000347 Temazepam impurity G 1 5 mg 1 (5RS)-7-chloro-1,4-dimethyl-5-phenyl-4,5-dihydro-1H-1,4- benzodiazepine-2,3-dione

0954 +5°C a

T0040800 Tenoxicam 2 100 mg 1 1156 +5°C g

Y0001114 Tenoxicam impurity mixture 1 0.0042 mg 1 1156 Yes +5°C g

Y0000621 Terazosin hydrochloride dihydrate 1 40 mg 1 2021 +5°C a

Y0000666 Terazosin for system suitability 1 0.5 mg 1 2021 Yes +5°C a

Y0000622 Terazosin impurity A 1 10 mg 1 2-chloro-6,7-dimethoxyquinazolin-4-amine 2021 +5°C a

Y0000665 Terazosin impurity E 1 10 mg 1 2,2'-(piperazine-1,4-diyl)bis(6,7-dimethoxyquinazolin-4-amine) 2021 +5°C a

Y0000623 Terazosin impurity L 1 10 mg 1 1-(furan-2-ylcarbonyl)piperazine 2021 +5°C a

Y0000624 Terazosin impurity N 1 10 mg 1 1-[[(2RS)-tetrahydrofuran-2-yl]carbonyl]piperazine 2021 Yes +5°C a

Y0000535 Terbinafine hydrochloride 1 10 mg 1 1734 +5°C a

Y0001143 Terbinafine for system suitability 1 10 mg 1 1734 Yes +5°C a

T0050000 Terbutaline sulfate 1 100 mg 1 0690 +5°C a

T0050015 Terbutaline impurity C 3 15 mg 1 1-(3,5-dihydroxyphenyl)-2-[(1,1-dimethylethyl)amino]-ethanone 0690 +5°C a

T0060000 Terconazole 2 250 mg 1 1270 +5°C a

T0071000 Terfenadine 1 100 mg 1 0955 +5°C a

T0080000 Terfenadine impurity A 2 20 mg 1 1-[4-(1,1-dimethylethyl)phenyl]-4-[4-(hydroxydiphenylmethyl) piperidin-1-yl]butan-1-one

0955 +5°C a

T0100000 Testosterone 2 30 mg 1 1373 +5°C g

T0210000 Testosterone caproate 1 50 mg 1 1048 +5°C g

T0240000 Testosterone decanoate 2 50 mg 1 99.8% Cœ„H÷ÿO– 1048, 1736 -20°C g(c)

Y0000696 Testosterone decanoate for system suitability 1 0.4 mg 1 1736 Yes -20°C g(c)

T0250000 Testosterone enantate 1 100 mg 1 1048 -20°C g(c)

Y0001317 Testosterone enantate for system suitability 1 2 mg 1 1048 Yes -20°C g(c)

Y0001312 Testosterone enantate for peak identification 1 10 mg 1 1048 Yes -20°C g(c)

Y0001313 Testosterone enantate impurity H 1 10 mg 1 delta-5-testosterone-3,17-dienantate 1048 -20°C g(c)

Y0000342 Testosterone for impurity D identification 2 20 mg 1 1373 +5°C g

Y0000343 Testosterone for system suitability 2 20 mg 1 1373 +5°C g

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T0260000 Testosterone isocaproate 2 50 mg 1 99.9% Cœ—H–‡O– 1048,1737 +5°C g

Y0000716 Testosterone isocaproate for system suitability 1 5 mg 1 1737 Yes +5°C g

T0300000 Testosterone propionate 2 60 mg 1 Testosterone propionate CRS 1 is suitable for 01/2008:1048 only 0297 Yes +5°C g

Y0001409 Testosterone propionate for system suitability 1 5 mg 1 0297 Yes +5°C g

T0400000 Tetanus vaccine (adsorbed) 3 30 mg 1 490 IU per ampoule for challenge assays in guinea-pigs260 IU per ampoule for challenge assays in mice

See leaflet,

20708

Yes -20°C a

Y0001087 Tetra-O-acetyl-mannose triflate 1 60 mg 1 100.0% CŒ—HŒ„F–OŒœS 2294 -20°C c

T0500000 Tetracaine hydrochloride 1 100 mg 1 0057 +5°C g

Y0001002 Tetracaine for system suitability 1 2 mg 1 0057 Yes +5°C g

T0550000 Tetracosactide 3 0.366 mg 2 366 µg per vial of CŒ–ÿHœŒÐN÷ÐO–ŒS 0644 Yes -20°C c

T0600000 Tetracycline hydrochloride 2 100 mg 1 96.7% CœœHœ—ClNœO‡ 0173,0198,01

99,

0210,0211,16

54

+5°C a

Y0001165 Tetrandrine 1 20 mg 1 2478 +5°C a

Y0000015 Tetrazepam - reference spectrum 1 n/a 1 1738 l

Y0000008 Tetrazepam impurity C 1 20 mg 1 7-chloro-5-cyclohexyl-1-methyl-1,3-dihydro-2H-1,4-benzodiazepin-2-one 1738 +5°C g

Y0000460 Tetryzoline hydrochloride 1 10 mg 1 2101 +5°C a

Y0000723 Thebaine - * narc 1 10 mg 1 99.5% CŒ„HœŒNO– 1839,1841 +5°C k

T0700000 Theobromine 1 100 mg 1 0298 +5°C a

T0800000 Theophylline 1 100 mg 1 0300,0301 +5°C g

Y0000294 Theophylline - reference spectrum 1 n/a 1 0299,0302 l

Y0000336 Thiamazole 1 125 mg 1 1706,0884 +5°C a

Y0000372 Thiamazole impurity A 1 15 mg 1 2,2-dimethoxy-N-methylethanamine 1706 +5°C a

New Y0000373 Thiamazole impurity C 2 20 mg 1 1-methyl-2-(methylsulphanyl)-1H-imidazole ; Batch 1 is valid until 31 August2013

1706 Yes +5°C a

Y0000467 Thiamine hydrochloride 2 10 mg 1 0303 +5°C a

Y0000059 Thiamine impurity E 2 10 mg 1 3-[(4-amino-2-methylpyrimidin-5-yl)methyl]-5-(2-hydroxyethyl)-4- methylthiazol-2(3H)-thione

0303,0531 +5°C a

Y0000060 Thiamine nitrate - reference spectrum 1 n/a 1 0531 l

T1100000 Thiamphenicol 1 125 mg 1 0109 +5°C a

Y0000546 Thioctic acid 1 110 mg 1 99.8% C‡HŒ÷OœSœ 1648 +5°C a

Y0000592 Thioctic acid for system suitability 1 10 mg 1 1648 +5°C a

Y0000545 Thioctic acid containing impurity B 1 30 mg 1 1648 +5°C a

Y0000109 Thiomersal 1 30 mg 1 1625 +5°C g

T1200000 Thiopental 1 500 mg 1 0212 +5°C a

Y0001478 Thiopental for system suitability 1 10 mg 1 0212 Yes +5°C a

Y0000704 Thioridazine 1 10 mg 1 2005 +5°C g

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T1300000 Thioridazine hydrochloride 1 100 mg 1 0586 +5°C g

Y0000541 Thioridazine for system suitability 1 0.21 mg 1 0586, 2005 Yes +5°C g

T1305100 Thioxanthene 3 20 mg 1 1347 +5°C g

T1305000 Thioxanthone 2 10 mg 1 1347 +5°C g

T1340000 Threonine 1 50 mg 1 0785,1049 +5°C a

T1350000 Thymol 2 50 mg 1 0791 +5°C g

T1410000 Tiabendazole 1 50 mg 1 0866 +5°C g

Y0000414 Tiamulin for peak identification 1 10 mg 1 1659 Yes +5°C g

Y0000333 Tiamulin hydrogen fumarate 2 500 mg 1 98.6% C–œH—ŒNO‡S 1659,1660 Yes +5°C g

Y0000379 Tiamulin - reference spectrum 1 n/a 1 1660 l

Y0000151 Tianeptine sodium - reference spectrum 1 n/a 1 2022 l

Y0000152 Tianeptine for system suitability 1 30 mg 1 2022 +5°C g

Y0000153 Tianeptine impurity A 1 20 mg 1 ethyl 7-bromoheptanoate 2022 +5°C g

T1405000 Tiapride hydrochloride 1 60 mg 1 1575 +5°C a

T1405050 Tiapride N-oxide 1 20 mg 1 1575 +5°C a

T1410900 Tiaprofenic acid 1 50 mg 1 1157 +5°C g

T1410910 Tiaprofenic acid impurity C 1 20 mg 1 (2RS)-2-(5-benzoylthiophen-3-yl)propanoic acid 1157 +5°C g

Y0000748 Tibolone - reference spectrum 1 n/a 1 1739 l

Y0000668 Tibolone for system suitability 1 10 mg 1 1739 Yes +5°C b

Y0000465 Ticarcillin monosodium 1 250 mg 1 93.2% CŒ—HŒ—NœNaOÿSœ Correction factor 1.054 0956 +5°C a

T1420010 Ticarcillin impurity A 1 50 mg 1 89.8% CŒ÷HŒÿNœO÷Sœ; (2S,5R,6R)-3,3-dimethyl-7-oxo-6-[[(thiophen-3-yl) acetyl]-amino]-4-thia-1-azabicyclo[3.2.0]heptane-2-carboxylic acid (decarboxyticarcillin)

0956 +5°C a

T1423000 Ticlopidine hydrochloride 3 50 mg 1 1050 +5°C g

T1423025 Ticlopidine impurity F 2 10 mg 1 6-(2-chlorobenzyl)-4,5,6,7-tetrahydrothieno[3,2-c]pyridine 1050 +5°C g

Y0000325 Tilidine hydrochloride hemihydrate - reference spectrum 1 n/a 1 1767 l

T1450000 Timolol maleate 3 100 mg 1 0572 +5°C a

Y0000644 (R)-timolol 1 20 mg 1 0572 +5°C a

Y0001270 Timolol for system suitability 1 5.045 mg 1 0572 Yes +5°C a

T1470000 Tinidazole 1 100 mg 1 1051 +5°C a

Y0000899 Tinidazole impurity A 1 10 mg 1 2-methyl-5-nitro-1H-imidazole 1051 +5°C a

T1471000 Tinidazole impurity B 4 20 mg 1 1-[2-(ethylsulphonyl)ethyl]-2-methyl-4-nitro-1H-imidazole ; Batch 3 is valid until 31 July 2012

1051 +5°C a

T1490000 Tinzaparin sodium 1 250 mg 1 0828 +5°C a

Y0000292 Tioconazole - reference spectrum 1 n/a 1 2074 l

Y0000282 Tioconazole for system suitability 1 50 mg 1 2074 Yes +5°C a

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Y0001188 Tiotropium bromide monohydrate 1 10 mg 1 2420 +5°C a

Y0001189 Tiotropium for system suitability 1 10 mg 1 2420 Yes +5°C a

Y0001179 Tiotropium impurity mixture 1 0.08 mg 1 2420 +5°C a

Y0001216 Tiotropium impurity F 1 10 mg 1 dithiophen-2-ylmethanone 2420 +5°C a

T1500000 Tobramycin 4 49 mg 1 49 mg per vial of CŒ‡H–ŸN—O„; Suitable for LC assay only 0645 Yes +5°C a

New Y0000383 All-rac-alpha-tocopherol for peak identification 2 50 mg 1 Batch 1 is valid until 31 August 2013 0692 Yes +5°C a

Y0000384 All-rac-alpha-tocopheryl acetate for peak identification 2 30 mg 1 0439 Yes +5°C a

T1550000 alpha-Tocopherol 6 500 mg 1 97.4% Cœ„H—ÐOœ ; Vitamin E 0692,1256,20

432

Yes +5°C a

T1600000 alpha-Tocopheryl acetate 8 500 mg 1 97.8% C–ŒH—œO– 0439,0691,12

57

+5°C a

Y0001210 Tobramycin for identification 1 250 mg 1 Suitable for identification tests only 0645 +5°C a

T1610000 RRR-alpha-Tocopheryl hydrogen succinate 1 150 mg 1 98.6% C––H—÷O— 1258,1259 Yes +5°C a

T1700000 Tolbutamide 1 100 mg 1 0304 +5°C a

Y0000154 Tolfenamic acid 1 100 mg 1 2039 +5°C g

T1707000 Tolnaftate 1 60 mg 1 1158 +5°C a

Y0001123 Tolnaftate for system suitability 1 10 mg 1 1158 +5°C a

Y0000461 Torasemide anhydrous 1 10 mg 1 2132 +5°C a

Y0001366 Torasemide impurity E 1 0.0006 mg 1 ethyl [[4-[(3-methylphenyl)amino]pyridin-3-yl]sulfonyl]carbamate 2132 +5°C a

Y0000462 Torasemide for system suitability 2 5 mg 1 2132 Yes +5°C a

Y0000155 Tramadol hydrochloride 3 75 mg 1 1681 +5°C g

Y0000156 Tramadol impurity A 4 25 mg 1 (1RS,2SR)-2-[(dimethylamino)methyl]-1-(3-methoxyphenyl)-cyclohexanol ; Batch 3 is valid until 31 January 2013

1681 +5°C g

Y0000157 Tramadol impurity E 3 15 mg 1 (2RS)-2-[(dimethylamino)methyl]cyclohexanone 1681 +5°C g

Y0000072 Tramazoline hydrochloride monohydrate 1 20 mg 1 1597 +5°C g

New Y0000065 Tramazoline impurity A 2 15 mg 1 N-(naphthalen-1-yl)-4,5-dihydro-1H-imidazol-2-amine ; Batch 1 is valid until31 August 2013

1597 Yes +5°C g

Y0000066 Tramazoline impurity B 1 10 mg 1 75% CŒ—HŒ„N–ÐO; Mixture of 1-acetyl-N-(5,6,7,8-tetrahydronaphthalen-1- yl)-4,5-dihydro-1H-imidazol-2-amine and 1-[(EZ)-1-[(5,6,7,8- tetrahydronaphthalen-1-yl)imino]ethyl]imidazolidin-2-one

1597 +5°C g

Y0000501 Trandolapril 1 10 mg 1 2245 +5°C a

Y0000495 Trandolapril impurity C 1 10 mg 1 (2S,3aR,7aS)-1-[(2S)-2-[[(1S)-3-cyclohexyl-1-(ethoxycarbonyl)propyl]amino]propanoyl]octahydro-1H-indole-2-carboxylic acid (hexahydrotrandolapril)

2245 +5°C a

Y0000496 Trandolapril impurity D 1 10 mg 1 ethyl (2S)-2-[(3S,5aS,9aR,10aS)-3-methyl-1,4-dioxodecahydro pyrazino[1,2-a]indol-2(1H)-yl]-4-phenylbutanoate (trandolapril diketopiperazine)

2245 +5°C a

T1810000 Tranexamic acid 4 50 mg 1 0875 Yes +5°C a

T1820000 Trapidil 1 50 mg 1 1576 +5°C g

T1820002 Trapidil impurity A 1 20 mg 1 5-methyl-[1,2,4]triazolo[1,5-a]pyrimidin-7-ol 1576 +5°C a

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T1820004 Trapidil impurity B 1 20 mg 1 1,2,4-triazol-3-amine 1576 +5°C g

Y0001172 Trehalose dihydrate 1 250 mg 1 89.8% CŒœHœœOŒŒ,2HœO 2297 +5°C a

T1850000 Tretinoin 2 50 mg 1 0693,1019,13

85

+5°C g(b)

T1899000 3,4,6-Tri-O-acetyl-D-glucal - reference spectrum 1 n/a 1 1325 l

G0400010 Triacetin - reference spectrum 1 n/a 1 1106 l

T1899990 Triamcinolone 2 150 mg 1 1376 +5°C a

T1900000 Triamcinolone acetonide 5 150 mg 1 98.6% Cœ÷H–ŒFOÿ ; Batch 4 is valid until 1 July 2012 0533,0867,10

75

Yes +5°C a

Y0001459 Triamcinolone acetonide for system suitability 1 10 mg 1 0533 Yes +5°C a

T1950000 Triamcinolone hexacetonide 2 100 mg 1 0533,0867 +5°C a

Y0000050 Triamcinolone impurity C 1 10 mg 1 9-fluoro-11ß,16alpha,17,21-tetrahydroxypregn-4-ene-3,20-dione 1376 +5°C a

Y0000837 Triamterene 1 10 mg 1 0058 +5°C a

Y0000870 Triamterene impurity B 1 0.5 mg 1 2,7-diamino-6-phenylpteridin-4-ol 0058 Yes +5°C a

T1975000 Triazolam - * psy 1 10 mg 1 1065 +5°C j

New Y0000165 Tribenoside 2 150 mg 1 98.3% Cœ„H–÷Oÿ ; Batch 1 is valid until 31 August 2013 1740 Yes +5°C g

Y0000166 Tribenoside impurity A 4 70 mg 1 90.3% C–ÐH–÷Oÿ; 3,5,6-tri-O-benzyl-1,2-O-(1-methylethylidene)-alpha-D- glucofuranose ; Batch 3 is valid until 1 May 2013

1740 Yes -20°C g(c)

Y0001055 Tributyl acetylcitrate 2 1 mL 1 1770 +5°C a

Y0000279 Tri-n-butyl phosphate 1 300 µl 1 1682 +5°C g

Y0000799 Tributyl acetylcitrate for peak identification 1 25 mg 1 1770 Yes +5°C a

T1977990 Tricaprin 1 150 mg 1 1410 -20°C c

T1977995 Tricaproin 1 40 mg 1 1410 -20°C c

T1978000 Tricaprylin 1 225 mg 1 1410 -20°C c

Y0000111 Trichloroacetic acid - reference spectrum 1 n/a 1 1967 l

T1985000 Trichlorotrifluoroethane 1 2.5 ml 1 0393 Yes +5°C g

T1986000 Triethyl citrate - reference spectrum 1 n/a 1 1479 l

T2000000 Trifluoperazine hydrochloride 1 100 mg 1 0059,20303 +5°C a

T2005000 Triflusal 1 50 mg 1 1377 +5°C a

T2005010 Triflusal impurity B 1 25 mg 1 2-hydroxy-4-(trifluoromethyl)benzoic acid 1377 +5°C a

Y0000720 Triglycerol diisostearate 1 200 mg 1 2032 +5°C a

Y0000108 Trihexyphenidyl hydrochloride 1 100 mg 1 1626 +5°C a

Y0000068 Trihexyphenidyl impurity A 1 20 mg 1 1-phenyl-3-(piperidin-1-yl)propan-1-one 1626 +5°C a

T2009000 Trilaurin 2 1250 mg 1 1410 -20°C c

Y0001319 Trimebutine maleate 1 10 mg 1 2182 +5°C a

Y0001260 Trimebutine for system suitability 1 1.017 mg 1 2181,2182 Yes +5°C a

Y0000092 Trimetazidine dihydrochloride - reference spectrum 1 n/a 1 1741 l

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Y0000093 Trimetazidine for system suitability 2 50 mg 1 1741 +5°C a

T2100000 Trimethadione 1 250 mg 1 100% CÿH„NO– 0440 +5°C a

Y0001497 3-Trimethylsilyl-1-propanesulfonic acid sodium salt 1 120 mg 1 91.8 % CÿHŒ—O–SSi,Na 2645, 2165 Yes +5°C a

T2200000 Trimethoprim 1 50 mg 1 0060 +5°C a

Y0000684 Trimethoprim for system suitability 3 0.00075 mg 1 Batch 2 is valid until 31 January 2013 0060 +5°C a

T2200010 Trimethoprim impurity B 4 15 mg 1 (2,4-diaminopyrimidin-5-yl)(3,4,5-trimethoxyphenyl)methanone 0060 +5°C a

T2450000 Trimethyltetradecylammonium bromide 2 200 mg 1 0378 +5°C g

T2500000 Trimipramine maleate 1 100 mg 1 0534 +5°C g

Y0000759 Trimipramine for peak identification 1 0.51 mg 1 0534 Yes +5°C g

T2500100 Trimyristin 1 500 mg 1 1410 -20°C c

T2501200 Tristearin 1 100 mg 1 1410 -20°C c

New T2545000 Trolamine 3 2250 mg 1 Batch 2 is valid until 31 August 2013 1577 +5°C a

Y0001184 Trolamine impurity A 1 250 mg 1 Ethanolamine 1577 +5°C g

Y0001183 Trolamine impurity B 1 1 ml 1 Diethanolamine 1577 +5°C a

T2550000 Trometamol 3 100 mg 1 Batch 2 is valid until 30 October 2012 1053 +5°C a

T2580000 Tropicamide 1 50 mg 1 1159,1197 +5°C a

Y0001247 Tropicamide impurity C 1 10 mg 1 (2RS)-3-hydroxy-2-phenylpropanoic acid (tropic acid) 1159 +5°C a

Y0001248 Tropicamide impurity D 1 10 mg 1 Phenylacetic acid 1159 +5°C a

Y0001316 Tropicamide for peak identification 1 10 mg 1 1159 +5°C a

Y0000616 Tropisetron hydrochloride 1 40 mg 1 2102 +5°C g

Y0000618 Tropisetron impurity B 1 10 mg 1 1H-indole-3-carboxylic acid 2102 +5°C a

T2580300 Tropine 1 50 mg 1 1308 +5°C a

Y0000429 Trospium chloride 1 10 mg 1 1798 +5°C a

Y0000432 Trospium impurity A 1 20 mg 1 hydroxydiphenylacetic acid (benzilic acid) 1798 +5°C a

Y0000431 Trospium impurity B 2 20 mg 1 (1R,3r,5S)-8-azabicyclo[3.2.1]oct-3-yl hydroxydiphenylacetate ; Batch 1 is valid until 30 September 2012

1798 +5°C a

Y0000430 Trospium impurity C 2 5 mg 1 (1R,3r,5S)-3-hydroxyspiro[8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium] 1798 +5°C a

Y0000497 Troxerutin 1 30 mg 1 2133 +5°C a

T2600000 Trypsin BRP 2 100 mg 1 0.707 microkatal per mg 0476,0579,05

80, 0694

Yes +5°C a

T2610000 Tryptophan 1 100 mg 1 1272 +5°C a

T2800000 Tubocurarine chloride 1 100 mg 1 87.75% C–ŸH÷œClœNœOÿ 0305 +5°C g

New T2880000 Tylosin 2 150 mg 1 1025 IU per mg ; Batch 1 is valid until 31 August 2013 1273,1274,16

61, 20702

Yes +5°C g

T2880100 Tylosin D 2 5 mg 1 1273,1274,16

61

+5°C g

Y0000498 Tylosin phosphate for peak identification 1 10 mg 1 1273,1274,16

61

Yes +5°C g

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T2880200 Tylosin tartrate - reference spectrum 1 n/a 1 1274 l

T2900000 Tyrosine 1 50 mg 1 0782,0895,11

61,

+5°C a

T3000000 Tyrothricin 2 20 mg 1 0907,1662 Yes +5°C a

U0020000 Ubidecarenone 2 50 mg 1 Batch 1 is valid until 1 June 2013 1578 +5°C a

U0020001 Ubidecarenone for system suitability 3 1 mg 1 1578 +5°C a

U0020008 Ubidecarenone impurity D 2 5 mg 1 5,6-dimethoxy-3-methyl-2-[(all-E)-3,7,11,15,19,23,27,31,35- nonamethylhexatriaconta-2,6,10,14,18,22,26,30,34-nonaenyl]benzene-1,4- dione

1578 +5°C a

U0100000 Uracil arabinoside 2 60 mg 1 0760 +5°C a

U0600000 Urea 2 100 mg 1 0743 +5°C a

U0800000 Ursodeoxycholic acid 2 100 mg 1 1189,1275 +5°C a

Y0001163 Ursodeoxycholic acid for system suitability 2 1.26 mg 1 Batch 1 is valid until 1 May 2013 1275 Yes +5°C a

Y0000834 Valaciclovir hydrochloride (anhydrous) 1 100 mg 1 1768 Yes +5°C a

Y0001225 Valaciclovir for system suitability 1 10 mg 1 1768 Yes +5°C a

Y0001096 Valaciclovir impurity D 1 10 mg 1 2-[(2-amino-6-oxo-1,6dihydro-9H-purin-9-yl)methoxy]ethyl N-ethyl-L-valinate 1768 +5°C a

Y0001097 Valaciclovir impurity E 1 10 mg 1 2-[(2-amino-6-oxo-1,6dihydro-9H-purin-9-yl)methoxy]ethyl N-[(benzyloxy)carbonyl]-L-valinate

1768 +5°C a

Y0001098 Valaciclovir impurity F para-toluenesulfonate 1 12 mg 1 2-hydroxyethyl L-valinate 1768 +5°C a

Y0001099 Valaciclovir impurity G 1 10 mg 1 N,N-dimethylpyridin-4-amine 1768 +5°C f

Y0000583 Valerian standardised dry extract 3 400 mg 1 0.43 % of C15H22O2 ; Batch 2 is valid until 31 August 2012 0453,1898,18

99,2400,2526

Yes -20°C c

V0030000 Valine 1 50 mg 1 0770,0771,07

96

+5°C a

Y0000584 Valnemulin hydrochloride 1 10 mg 1 2137 +5°C a

Y0000533 Valnemulin hydrogen tartrate 1 120 mg 1 98.7% C–—H—‡NœOŒŒS 2137 +5°C a

Y0000585 Valnemulin for peak identification 1 10.25 mg 1 2137 Yes +5°C a

Y0000586 Valnemulin impurity E 1 10 mg 1 (3aS,4R,5S,6S,8R,9R,9aR,10R)-6-ethenyl-5-hydroxy-4,6,9,10-tetramethyl-1- oxodecahydro-3a,9-propano-3aH-cyclopenta[8]annulen-8-yl 2-hydroxyacetate (pleuromulin)

2137 +5°C a

V0033000 Valproic acid 2 100 mg 1 1378 +5°C a

Y0001422 Valproic acid for system suitability 1 10 mg 1 1378,0678 Yes +5°C a

Y0001132 Valsartan 1 10 mg 1 2423 +5°C a

Y0001131 Valsartan for peak identification 1 10 mg 1 2423 Yes +5°C a

New Y0001145 Valsartan for system suitability 2 0.202 mg 1 Batch 1 is valid until 31 August 2013 2423 Yes +5°C a

V0045000 Vancomycin hydrochloride 3 100 mg 1 102000 IU per vial 1058,20702 Yes -20°C a

V0050000 Vanillin 1 100 mg 1 0747 +5°C a

Y0001198 Varicella vaccine ( live) 1 420 mg 1 0648 Yes -80°C d

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Y0000561 Vecuronium bromide 1 10 mg 1 1769 +5°C g

Y0000625 Vecuronium for peak identification 1 10 mg 1 1769 Yes +5°C g

Y0001093 Vedaprofen 1 5 mg 1 2248 +5°C g

Y0001118 Vedaprofen impurity mixture 1 0.006 mg 1 2248 Yes +5°C g

Y0000587 Venlafaxine hydrochloride 2 50 mg 1 2119 +5°C g

Y0000588 Venlafaxine for system suitability 3 1.002 mg 1 Batch 2 is valid until 31 December 2012 2119 +5°C g

V0100000 Verapamil hydrochloride 1 100 mg 1 0573 +5°C g

V0100018 Verapamil impurity I 3 5 mg 1 (2RS)-2-(3,4-dimethoxyphenyl)-2-[2-[[2-(3,4-dimethoxy-phenyl)ethyl] (methyl)amino]ethyl]-3-methylbutanenitrile hydrochloride

0573 +5°C g

V0100026 Verapamil impurity M 2 10 mg 1 5,5'-[[2-(3,4-dimethoxyphenyl)ethyl]imino]bis[2-(3,4-dimethoxyphenyl)-2-(1- methylethyl)pentanenitrile]

0573 +5°C g

Y0000661 Verbenalin 1 1.015 mg 1 0.97 mg per vial of CŒŸHœ÷OŒÐ 1854 +5°C a

V0180000 VERO cells 1 1 ml 2 Cell lines (kidney, african green monkey, Cercopithecus aethiops) titration of live measles, mumps and rubella vaccines

0213,0538,10

57

Yes Liquid

nitrogen

d

Y0001400 Vigabatrin 1 10 mg 1 2305 +5°C a

Y0001401 Vigabatrin impurity A 1 25 mg 1 94.7% CÿH„NO; (5RS)-5-ethenylpyrrolidin-2-one 2305 Yes -20°C c

Y0001402 Vigabatrin impurity B 1 20 mg 1 (2E)-2-(2-aminoethyl)but-2-enoic acid 2305 +5°C a

Y0001404 Vigabatrin impurity D 1 50 mg 1 4-aminobutanoic acid 2305 +5°C a

Y0001403 Vigabatrin impurity E 1 10 mg 1 2-[(2RS)-2-aminobut-3-enyl]propanedioic acid 2305 +5°C a

V0300000 Vinblastine sulfate 4 5.01 mg 1 5.01 mg per vial of C÷ÿHÿÐN÷OŒ–S 0748,0749 -80°C g(d)

V0305000 Vinblastine sulfate - reference spectrum 1 n/a 1 0748 l

V0400000 Vincristine sulfate 5 4.96 mg 1 4.98 mg per vial of C÷ÿH—‡N÷OŒ÷S 0748,0749 -80°C d

V0405000 Vincristine sulfate - reference spectrum 1 n/a 1 0749 l

V0500000 Vindesine sulfate 2 5.11 mg 1 5.11 mg per vial of C÷–H—ŸN—OŒŒS ; Batch 2 is valid until 18 February 2013 1276 -80°C g(d)

V0500010 Vindesine sulfate - reference spectrum 1 n/a 1 1276 l

Y0000463 Vinorelbine tartrate 2 50 mg 1 2107 -80°C g(d)

Y0000464 Vinorelbine impurity B 3 7 mg 1 4-O-deacetylvinorelbine 2107 -80°C g(d)

Y0000589 Vinpocetine 1 10 mg 1 2139 +5°C a

Y0000590 Vinpocetine impurity A 1 10 mg 1 (12RS,13aSR,13bSR)-13a-ethyl-12-hydroxy-2,3,5,6, 12,13,13a,13b- octahydro-1H-indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12- carboxylate (ethyl vincaminate)

2139 +5°C a

Y0000591 Vinpocetine impurity B 1 10 mg 1 (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)

2139 +5°C a

Y0000790 Vinpocetine impurity C 1 10 mg 1 ethyl (13aS,13bS)-13a-ethyl-9-methoxy-2,3,5,6,13a,13b-hexahydro-1H- indolo[3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (methoxyvinpocetine)

2139 Yes +5°C a

Y0000760 Vinpocetine impurity D 1 10 mg 1 (12RS,13aRS,13bRS)-13a-ethyl-2,3,5,6,12,13,13a,13b-octahydro-1H-indolo [3,2,1-de]pyrido[3,2,1-ij][1,5]naphthyridine-12-carboxylate (dihydrovinpocetine)

2139 +5°C a

Order

Code


vial

Sale

Unit


charges

Y0000793 Vinyl acetate 1 200 mg 1 2152 +5°C g

Y0001395 Voriconazole 1 120 mg 1 2576 Yes +5°C g

Y0001396 Voriconazole impurity B 1 10 mg 1 (2RS,3SR)-2-(2,4-difluorophenyl)-3-pyrimidin-4-yl-1-(1H-1,2,4-triazol-1-yl)butan-2-ol

2576 +5°C g

Y0001398 Voriconazole impurity D 1 10 mg 1 (2R,3S)-2-(2,4-difluorophenyl)-3-(5-fluoropyrimidin-4-yl)-1-(1H-1,2,4- triazol-1-yl)butan-2-ol (epi-voriconazole)

2576 +5°C g

Y0001397 Voriconazole impurity E 1 50 mg 1 [(1R,4S)-7,7-dimethyl-2-oxobicyclo[2.2.1]hept-1-yl]methanesulfonic acid((+-)-camphorsulfonic acid)

2576 +5°C g

W0100000 Warfarin sodium 2 10 mg 1 0698,0699 +5°C g

Y0000778 Warfarin sodium clathrate 1 10 mg 1 0699 +5°C g

X0075000 Xylazine hydrochloride 1 125 mg 1 1481 +5°C g

Y0000158 Xylazine impurity C 2 50 mg 1 2,6-dimethylphenyl isothiocyanate 1481 +5°C g

Y0000159 Xylazine impurity E 2 15 mg 1 87.5% CŒÐHŒ–NSœ ; methyl (2,6-dimethylphenyl)carbamodithioate 1481 Yes +5°C g

Y0001224 Xylazine impurity mixture 1 0.02 mg 1 1481 Yes +5°C g

X0080000 Xylitol 1 500 mg 1 99.2% C—HŒœO— 1381 +5°C a

X0100000 Xylometazoline hydrochloride 2 100 mg 1 0972,1162 +5°C g

X0101000 Xylometazoline impurity A 1 10 mg 1 N-(2-aminoethyl)-2-(4-1,1-dimethylethyl-2,6-dimethylphenyl) acetamide 1162 +5°C g

X0200000 Xylose 1 100 mg 1 1278 +5°C a

Y0000656 Yohimbine hydrochloride 1 20 mg 1 99.1% CœŒHœŸClNœO– 2172 Yes +5°C g

Z1900000 Zidovudine 2 60 mg 1 99.5% CŒÐHŒ–N—O÷ 1059 +5°C a

Z1902000 Zidovudine impurity A 2 10 mg 1 1-[(2¢,5£)-5-hydroxymethyl-2,5-dihydro-2-furyl]-5-methyl pyrimidine-2,4 (1§,3§)-dione

1059 +5°C a

Z1904000 Zidovudine impurity B 2 15 mg 1 1-(3-chloro-2,3-dideoxy-ß-D-ribofuranosyl)-5-methylpyrimidine-2,4(1§,3§)- dione 1059 +5°C a

Z2000000 Zinc acexamate 1 50 mg 1 1279 +5°C a

Z2000010 Zinc acexamate impurity A 1 50 mg 1 6-[[6-(acetylamino)hexanoyl]amino]hexanoic acid 1279 +5°C a

Y0001286 Ziprasidone hydrochloride monohydrate 1 100 mg 1 95.6% CœŒHœœClœN÷OS 2421 Yes +5°C a

Y0001272 Ziprasidone for system suitability 1 1 10 mg 1 2421 Yes +5°C a

Y0001241 Ziprasidone for system suitability 2 1 0.465 mg 1 2421 Yes +5°C a

Z2500000 Zolpidem tartrate - * psy 3 200 mg 1 1280 +5°C j

Z2500010 Zolpidem impurity A 3 10 mg 1 N,N'-dimethyl-2-[7-methyl-2-(4-methylphenyl)imidazol[1,2-a] pyridin-3-yl]acetamide

1280 +5°C a

Z3000000 Zopiclone -* psy 2 40 mg 1 Batch 1 is valid until 31 January 2013 1060 +5°C j

Z3001000 Zopiclone oxide 3 20 mg 1 Batch 2 is valid until 1 April 2013 1060 +5°C g

Y0000062 Zuclopenthixol decanoate - reference spectrum 1 n/a 1 1707 l

Y0000534 Zuclopenthixol for system suitability 1 0.26 mg 1 1707 Yes +5°C a

Y0000083 Zuclopenthixol impurity B 1 10 mg 1 2-chloro-9H-thioxanthen-9-one 1707 +5°C a

list of european pharmacopoeia reference standards · pdf filelist of european pharmacopoeia...

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