Last Updated on October 6, 2024 by The Health Master
The Indian Pharmacopoeia Commission (IPC) has updated the Indian Pharmacopoeia (IP) 2022 with five new Indian Pharmacopoeial Reference Standards (IPRS) and seven new impurity reference substances in an effort to guarantee the quality, safety, and efficacy of pharmaceutical products.
Ghaziabad-based IPC offers IPRS, which serves as a fingerprint for identifying an article under test and its purity in accordance with IP requirements. They are the official standards to be used in cases of arbitration.
The recently introduced IPRS are:
- Disopyramide phosphate,
- Dolutegravir sodium,
- Estradiol hemihydrate,
- Propofol,
- Tenofovir alafenamide fumarate.
On the other hand, impurity standards are used to perform the system suitability, qualitative and quantitative parameters for compliance to the Indian Pharmacopoeia monograph.
The commission stated that certain monographs require the use of a chemical reference substance or a biological reference preparation or a reference spectrum.
These are authentic specimens chosen and verified on the basis of their suitability for intended use as prescribed in the pharmacopoeia and are not necessarily suitable in other circumstances.
The list of newly launched impurity reference substances includes:
- Clobazam impurity A,
- Levocetirizine amide,
- Lumefantrine-related compound A,
- Quetiapine impurity I,
- Tamoxifen citrate impurity standard,
- Tinidazole impurity B,
- Trimethoprim impurity B.
Buying Indian Pharmacopoeial Reference Standard is a social and legal responsibility of the industry, stated the commission.
Last month the Union ministry of health and family health launched the 9th edition of IP (IP 2022) containing 652 pharma reference substances covering 70 per cent requirement of reference materials used for quality control in the country.
9th edition of Indian Pharmacopoeia released: Details
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The newly launched IPRS has taken the number of pharma reference substances in IP to 657.
The IP 2022 also contained 300 impurity standards which are crucial for managing pharmaceutical quality.
With the launch of 7 new impurities, the number of impurities in IP has increased to 307.
The vision of IPC is to promote the highest standards of drugs for use in humans and animals within the practical limits of the technologies available for manufacture and analysis.
IPC is created to set standards for drugs in the country. Its basic function is to regularly update the standards of drugs commonly required for the treatment of diseases prevailing in this region.
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.
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