IPC adds 15 new impurities Reference Substances and 11 IP Reference Substances

List of 15 new impurities Reference Substances and 11 IP Reference Substances

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Last Updated on December 23, 2021 by The Health Master

List of 15 new impurities Reference Substances and 11 IP Reference Substances

The Indian Pharmacopoeia Commission (IPC) has added 15 new impurities Reference Substances and 11 new Indian Pharmacopoeia Reference Substances.

The list of new impurity reference substances includes:

  • Betahistine Hydrochloride Impurity A,
  • Bisacodyl Impurity B,
  • Bumetanide Impurity B,
  • Cefotaxime Sodium Impurity A,
  • Dipivefrine Hydrochloride Impurity A,
  • Entacapone / Entacapone Tablet Impurity A,
  • Clofazimine Impurity E,
  • Orphenadrine Hydrochloride Impurity E,
  • Orphenadrine Citrate,
  • Raltegravir Potassium Compound E,
  • Sulbactam Sodium Compound D,
  • Sulbactam Sodium Compound E,
  • Sulbactam Sodium compound F,
  • Zolmitriptan Impurity C,
  • Zolpidem Tartrate Impurity A.

The list of new IP reference substances includes:

  • A-Arginine Monohydrochloride 200mg,
  • Itopride Hydrochloride 200mg,
  • L-Alanine 200mg,
  • L-Glutathione 200mg,
  • L-Histidine Monohydrochloride Monohydrate 200mg,
  • L-Lysine Acetate 200mg,
  • L-Lysine Monohydrochloride 200mg,
  • L-Methionine 200mg,
  • L-Tryptophan 200mg,
  • L-Valine 200mg,
  • N-Acetyl L-Cysteine 200mg.

IP Reference Substances, abbreviated to IPRS (and referred to as RS in the individual monographs) are issued by the Indian Pharmacopoeia Commission (IPC). They are the official standards to be used in cases of arbitration.

Secondary Standards (Working Standards) may be used for routine analysis, provided they are standardized at regular intervals against the Reference Substances.

Biological Reference Substances, also abbreviated to IPRS, and Standard Preparations of antibiotics are issued by agencies authorised by the IPC.

They are standardized against the International Standards and Reference Preparations established by the World Health Organization (WHO).

The vision of IPC is to promote the highest standards of drugs for use in humans 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 (NFI) on a regular basis besides providing IP reference substances and training to the stakeholders on pharmacopoeial issues.

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