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Indian Pharmacopoeia Commission (IPC) Ministry of Health and Family Welfare, Government of India.

2/20/2015 1:05 PM 1 Indian Pharmacopoeia Commission

By : Dr. P. L. SAHU Principal Scientific Officer, IPC, Ghaziabad.

Overview


Present status of IPRS

New IPRS Targeted for 2015

Roadmap for new IPRS in 2015

Present Status of IPRS


The availability of IPRS in year 2014 : 422 Nos.

The availability of Impurity in year 2014 : 20 Nos.

The list of available IPRS & Impurity is available at

IPC website (www.ipc.gov.in)

Target of IPRS in 2015


The target of total IPRS in year 2015 : 500 Nos.

The target of total Impurity Standards

in year 2015 : 55 Nos.

Total IPRS and Impurity Standards in

in year 2015 : 555 Nos.

IPRS


20 57

112

273

347

422

500

0

50

100

150

200

250

300

350

400

450

500

2009-10 2010-11 2011-12 2012-13 2013-14 Dec-14 2015

No

. of

IPR

S

YEAR

Availability of IP Reference Substance

Impurity Standards


2

10

20

55

0

10

20

30

40

50

60

2011-12 2013-2014 2013-2014 2015

No. of Impurities

Years

Availability of Impurity Standards

Roadmap for new IPRS & impurity Standard


17 new Impurity standards are issued for

characterization in January 2015

(The list is attached as Annexure - I)

25 New IPRS to be issued in Q1 for Characterization

(The list is attached as Annexure - II)

Another 18 New Impurity to be issued in Q2 2015

(The list is attached as Annexure - III)

Roadmap for new IPRS & impurity Standard


26 New IPRS to be issued in Q3 for

characterization. (The list is attached as Annexure - IV)

27 New IPRS to be issued in Q4 for

characterization (The list is attached as Annexure - V)

2/20/2015 1:05 PM 9

S.No. Name of the impurity Name of Monograph LOT NO.

1 thymidine Stavudine IMP/11/14

2 2-Ethylhexanoic acid

Amoxycillin Sodium/ Dicloxacillin

Sodium IMP/12/14

3

hydrazine sulphate

Hydralazine Hydrochloride/

Isoniazid IMP/13/14

4 Piperazine hexahydrate (Trimetazidine

Impurity G)

trimetazidine IMP/14/14

5 benzene sulphonic acid S-Amlodipine Besylate IMP/15/14

6

N, N-Dimethylaniline

Ampicillin/ Ampicillin Sodium/

Ampicillin Trihydrate/

Amoxycillin Sodium/ Amoxycillin

Trihydrate/ Cloxacillin Sodium/

Dextromethorphan Hydrobromide/

Dicloxacillin Sodium/ Piperacillin

IMP/16/14

7 palmitic acid Propofol Injection IMP/17/14

8 thymine (zidovudine impurity C) Zidovudine/Stavudine IMP/18/14

9 Theobromine Theophylline IMP/19/14

Annexure I

Indian Pharmacopoeia Commission

2/20/2015 1:05 PM 10

S.No. Name of the impurity Name of Monograph LOT NO.

10 5-Chloro-1-methyl-4-nitroimidazole Azathioprine IMP/20/14

11

thiourea

Quinine Sulphate/

Quinidine Sulphate/

Quinine Bisulphate/

Quinine

Dihydrochloride

IMP/21/14

12

imidazole (Clotrimazole impurity D)

Ondansetron

Hydrochloride/Clotrim

azole

IMP/22/14

13 Stearic Acid Stearic Acid IMP/23/14

14 [(+)-(S)-(o-chlorophenyl)-6,7-

dihydrothieno(3,2-c]pyridine-5(4H)-acetic

acid] RS

(clopidogrel impurity A RS)

Clopidogrel

IMP/24/14

15 montelukast styrene Montelukast Sodium IMP/25/14

16 montelukast sulphoxide isomers Montelukast Sodium IMP/26/14

17 Irebesartan Impurity A Irbesartan IMP/27/14

Annexure I (Cont….)


2/20/2015 1:05 PM 11

Annexure – II S.No.

Name of IPRS LOT NO.

1 Docusate Sodium IPRS/81/14

2 Isotretinoin IPRS/82/14

3 Povidone IPRS/83/14

4 Propyl Paraben IPRS/84/14

5 Malic Acid IPRS/85/14

6 Sorbitol Solution 70% IPRS/88/14

7 Cetosteryl Alcohol IPRS/89/14

8 Methyl Paraben IPRS/91/14

9 Crospovidone IPRS/92/14

10 Cellulose Acetate Phthalate (CAP) IPRS/93/14

11 Chlorpromazine Hydrochloride IPRS/94/14

12 Meconazole IPRS/95/14


2/20/2015 1:05 PM 12

Annexure – II (cont….) S.No.


13 Butyl Hydroxytoluene IPRS/97/14

14 Menthol IPRS/98/14

15 Diethyl Phthalate IPRS/99/14

16 Citric Acid IPRS/100/14

17 Sodium Starch Glycolate IPRS/101/14

18 Saccharine Sodium IPRS/102/14

19 Fluvoxamine Maleate IPRS/103/14

20 Midazolam IPRS/104/14

21 Ipratropium Bromide IPRS/105/14

22 Ethacrynic Acid IPRS/106/14

23 Brinzolamide IPRS/107/14

24 Pimozide IPRS/108/14

25 Sorafenib Tosylate IPRS/109/14


2/20/2015 1:05 PM 13

Annexure – III S.No.

Name of the impurity Name of Monograph LOT NO.

1 (RS)-1-[(4-

chlorophenyl)phenylmethyl]piperazine RS

(cetirizine

impurity A)

(Cetirizine Hydrochloride) IMP/01/15

2 Baclofen impurity A Baclofen IMP/02/15

3

Benzothiadiazine impurity A ( 4-amino-6-

chloro-1,3-benzenedisulfonamide )

Irbesartan and

Hydrochlorothiazide

Tablets / Valsartan and

Hydrochlorothiazide Tablets

IMP/03/15

4 2-benzylpyridine

(pheniramine impurity A)

Pheniramine Maleate

IMP/04/15

5 Tropicamide impurity C (tropic acid) Tropicamide IMP/05/15

6 Cyclizine impurity A ( 1-methylpiperazine)

N-methylpiperazine

Cyclizine Hydrochloride /

Diethylcarbamazine Citrate

IMP/06/15

7 potassium sodium (+)-tartrate Metoprolol Injection IMP/07/15

8 2-bromo-6-

methoxynaphthalene (Naproxen impurity N)

Naproxen IMP/08/15

9 2-naphthylacetic acid (2-naphthalene acetic

acid)

Naproxen Suppositories IMP/09/15


2/20/2015 1:05 PM 14

Annexure – III (cont…) S.No.


10 D-α-( (4-hydroxyphenyl) glycine

(cefadroxil impurity A)

Cefadroxil IMP/10/15

11 Hexacosane Isoxsuprine Hydrochloride IMP/11/15

12 Phthalazine Hydralazine Hydrochloride IMP/12/15

13 Sodium lactate Ciprofloxacin Injection IMP/13/15

14 Tolnaftate impurity A (2-naphthol) Tolnaftate, Thiacetazone IMP/14/15

15 Mesalazine impurity G ( 2,5-

dihydroxybenzoic acid)

Mesalazine IMP/15/15

16 Mesalazine impurity E (4-

aminosalicylic acid)

Mesalazine Prolonged-release

Tablets

IMP/16/15

17 Mesalazine impurity D (3-

aminobenzoic acid )


18 Mesalazine impurity B (3-

aminophenol)



2/20/2015 1:05 PM 15

Annexure – IV S.No.


1 Zolmitriptan IPRS/110/14

2 Erlotinib Hydrochloride IPRS/111/14

3 Docetaxel Anhydrous IPRS/112/14

4 Citicoline Sodium IPRS/113/14

5 Torsemide IPRS/114/14

6 Progesterone IPRS/115/14

7 Ketotifen Fumarate IPRS/116/14

8 Benzoic Acid IPRS/117/14

9 Citric Acid Monohydrate IPRS/118/14

10 Sorbic Acid IPRS/119/14

11 Urea IPRS/120/14

12 Phenobarbitone Sodium IPRS/151/14

13 Carbimazole IPRS/152/14


2/20/2015 1:05 PM 16

Annexure – IV (Cont….) S.No.


14 Prothionamide IPRS/155/14

15 Rebamipide IPRS/156/14

16 Propylthiouracil IPRS/157/14

17 Sodium Aminosalicylate IPRS/158/14

18 Perphenazine IPRS/160/14

19 Seratrodast IPRS/161/14

20 Clobetasone Butyrate IPRS/162/14

21 Dapsone IPRS/163/14

22 procyclidine Hydrochloride IPRS/164/14

23 Choline Fenofibrate IPRS/165/14

24 Stearic Acid IPRS/166/14

25 piperazine (hexahydrate) IPRS/167/14

26 Ceftazidime IPRS/168/14


2/20/2015 1:05 PM 17

Annexure – V S.No.


1 Betamethasone IPRS/169/14

2 Prednisolone IPRS/170/14

3 Indinavir Sulphate IPRS/171/14

4 Sorbitol IPRS/172/14

5 Flurbiprofen IPRS/173/14

6 Sodium Lauryl Sulphate IPRS/174/14

7 Oxytetracycline IPRS/175/14

8 Danazol IPRS/176/14

9 Menthone IPRS/01/15

10 Eugenol IPRS/02/15

11 Quercetin IPRS/03/15

12 Linalool IPRS/04/15

13 Camphor IPRS/05/15


2/20/2015 1:05 PM 18

Annexure – V (Cont….) S.No. Name of IPRS LOT NO.

14 Borneol IPRS/06/15

15 Voglibose IPRS/07/15

16 Zonisamide IPRS/08/15

17 Fingolimod Hydrochloride IPRS/09/15

18 Clobetasol Propionate IPRS/10/15

19 Clomifene Citrate IPRS/11/15

20 Prochlorperazine Mesylate IPRS/12/15

21 Dobutamine Hydrochloride IPRS/13/15

22 Fluphenazine Hydrochloride IPRS/14/15

23 Flurazepam Hydrochloride IPRS/15/15

24 Oxazepam IPRS/16/15

25 Zopiclone IPRS/17/15

26 Aspartame IPRS/18/15

27 Adrenaline Tartrate IPRS/25/15


2/20/2015 1:05 PM 19

Thank you !!


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