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IPC adds 9 new IP impurities standards

IPC adds 9 new IP impurities standards

The Indian Pharmacopoeia Commission (IPC) has added 9 new IP impurities standards which includes Bromhexine Hydrochloride Impurity C, Cabergoline Impurity A, Cilostazol Impurity B, Citalopram Impurity B, Fosinopril Impurity A, o-toluene sulfonamide, p-toluene sulfonamide, Tributyl o-acetyl citrate/Acetyl Tributyl citrate, Vildagliptin Impurity D.

Impurity standards are used to perform the system suitability, qualitative and quantitative parameters for compliance to 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. IPC in collaboration with USP also conducted a webinar on “Fundamentals of Dissolution” as a part of Capability Building initiative. The webinar was conducted “exclusively” for MSME (Micro, small and medium enterprises).

The session conducted by Dr. Rajeev Singh Raghuvanshi - Secretary-cum-Scientific Director, IPC and Josan Thomas, Scientific Liaison, USP India, covered the science behind dissolution, fundamentals of dissolution testing, and specifics related to the qualification of USP apparatus 1 and apparatus 2. The session saw great response with 339 participants from 149 unique companies.

The panelists for webinar includes Dr. Rajeev Singh Raghuvanshi - Secretary-cum-Scientific Director, IPC, Dr. Robin Kumar - Principal Scientific Officer, Dr. Gaurav Pratap Singh Jadaun - Senior Scientific Officer, IPC, Josan Thomas, Scientific Liaison, USP India, Mr. Girish Kapur- Vice President, USP India, Joseph Eaton - Senior Manager, USP Rockville.

The vision of IPC is to promote the highest standards of drugs for use in human and animals within practical limits of the technologies available for manufacture and analysis.

IPC is an autonomous institution of the ministry of health and family welfare, Government of India. IPC is created to set standards of drugs in the country. Its basic function is to update regularly the standards of drugs commonly required for 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

More news about: safety | Published by Darshana | December - 07 - 2021 | 880

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