Indian Pharmacopoeia Commission (IPC) reached the1000 mark with Sitagliptin Impurity A
With the launch of Sitagliptin Impurity A, the inventory of Indian Pharmacopoeial Reference norms has reached the 1000 mark. The Indian Pharmacopoeia Commission( IPC) has come the third Pharmacopoeia Commission in the world to have further than 1000 Pharmacopoeial Reference norms in its force.
Sitagliptin is a dipeptidyl peptidase- 4 inhibitor and used to ameliorate glycemic control in cases with type 2 diabetes.
During the 50th Scientific Body meeting of Indian Pharmacopoeia Commission on September 28, 2022, 1000th IP Reference Standard- Sitagliptin contamination A was launched by members of the Scientific Body.
Sitagliptin is among 15 contaminations launched by IPC lately. The other contaminations are Amiodarone Impurity A, Amiodarone Impurity B, Amlodipine contamination D, Cefradine, Cephraddine, Diazepam contamination B, Econazole Nitrate, Fenbendazole Impurity B, Fluconazole Impurity C, Indapamide Impurity A, Norfloxacin Impurity E, Quetiapine Impurity A, Teneligliptin Impurity C, 6- chloro-3-hydroxyamide( Chlor Homolog contamination).
IPC launched the first Reference Standard ofanti-diabetic medicine, Pioglitazone in 2010. latterly Indian Pharmacopoeia 2014 contained separate compositions foranti-diabetic medicaments, metformin tablets and metformin extended release tablets.
In August this time IPC added five new Indian Pharmacopoeial Reference norms and seven new contamination reference substances to Indian Pharmacopoeia 2022. The list of contamination reference substances contained clobazam contamination A, levocetirizine amide, lumefantrine affiliated emulsion A, quetiapine contamination I, tamoxifen citrate contamination standard, tinidazole contamination B, trimethoprim contaminationB.
On the other hand, the list of Indian Pharmacopoeial Reference norms included disopyramide phosphate, dolutegravir sodium, estradiol hemihydrate, propofol, tenofovir alafenamide fumarate. Contamination norms are used to perform the system felicity, qualitative and quantitative parameters for compliance to Indian Pharmacopoeia causerie.
The IP is a fairly recognized book of norms for medicines and their phrasings in India. The norms of identity, chastity and strength specified in IP are to assure quality of the drug. The accreditation of the commission is to perform,inter-alia, functions similar as modification and publication of the Indian Pharmacopoeia and National Formulary of India on a regular base besides delivering IP reference substances and training to the stakeholders on pharmacopoeial issues. Buying Indian Pharmacopoeial Reference Standard is a social and legal responsibility of the assiduity, stated the commission.
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