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IPC launches 1000th IP Reference Standard

Sitagliptin is a dipeptidyl peptidase-4 inhibitor and used to improve glycemic control in patients with type 2 diabetes.

The Health Master

October 3, 2022

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Last Updated on October 7, 2024 by The Health Master

With the launch of Sitagliptin Impurity A, the inventory of Indian Pharmacopoeial Reference Standards has reached the 1000 mark.

The Indian Pharmacopoeia Commission (IPC) has become the third pharmacopoeia commission in the world to have more than 1000 pharmacopoeial reference standards in its inventory.

Sitagliptin is a dipeptidyl peptidase-4 inhibitor and is used to improve glycemic control in patients with type 2 diabetes.

At the 50th Scientific Body meeting of the Indian Pharmacopoeia Commission on September 28, 2022, the 1000th IP Reference Standard—Sitagliptin Impurity A—was launched by members of the Scientific Body.

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Sitagliptin is among 15 impurities launched by IPC recently.

The other impurities are:

Amiodarone Impurity A,
Amiodarone Impurity B,
Amlodipine Impurity D,
Cefradine, Cephraddine,
Diazepam Impurity 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 impurity).

IPC launched the first Reference Standard of the anti-diabetic drug, Pioglitazone, in 2010.

Later, the Indian Pharmacopoeia 2014 contained separate monographs for anti-diabetic drugs, metformin tablets, and metformin prolonged-release tablets.

In August this year, IPC added five new Indian Pharmacopoeial Reference Standards and seven new impurity reference substances to Indian Pharmacopoeia 2022.

The list of impurity reference substances contained:

Clobazam impurity A,
Levocetirizine amide,
Lumefantrine-related compound A,
Quetiapine impurity I,
Tamoxifen citrate impurity standard,
Tinidazole impurity B,
Trimethoprim impurity B.

On the other hand, the list of Indian Pharmacopoeial Reference Standards included disopyramide phosphate, dolutegravir sodium, estradiol hemihydrate, propofol, and tenofovir alafenamide fumarate.

Impurity standards are used to perform the system suitability and qualitative and quantitative parameters for compliance with the Indian Pharmacopoeia monograph.

The IP is a legally recognized book of standards for drugs and their formulations in India.

The standards of identity, purity, and strength prescribed in IP are to ensure the quality of the medicine.

The mandate of the commission is to perform, inter-alia, functions such as revision and publication of the Indian Pharmacopoeia and National Formulary of India on a regular basis besides providing IP reference substances and training to the stakeholders on pharmacopoeial issues.

Buying Indian Pharmacopoeial Reference Standard is a social and legal responsibility of the industry, stated the commission.

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