IPC adds these 9 new IP impurities standards

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

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Last Updated on December 8, 2021 by The Health Master

The Indian Pharmacopoeia Commission (IPC) has added nine new IP impurities standards, which include:

  • 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 with 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.

As a part of the Capability Building initiative, IPC in collaboration with USP, also conducted a webinar on “Fundamentals of Dissolution” as a part of the 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 a great response with 339 participants from 149 unique companies.

The panelists for the webinar include:

  • 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 humans and animals within the 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. The IPC was 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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