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Indian Pharmacopoeia Commission adds 10 new impurities standards
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Nandita Vijay, Bengaluru
January 30 , 2018
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The Indian Pharmacopoeia Commission (IPC) Ghaziabad has added 10 new
impurities standard. Now a total of 117 impurities and 537 Indian
Pharmacopeia Reference Standards (IPRS) are available at IPC for
stakeholders.
The move is to strengthen its availability of
impurity standards and reference substances. The new list of impurity
standards covered Carvedilol Impurity A, 3 Impurities of Quiniodochlor,
Diazepam Impurity A, Alprostadil Impurity K, Butylparaben Impurity E and
Tramadol Impurity A, Impurity of Carbamazepine (10,11
–Dihydrocarbamazepine) Oxacillin Impurity A, said Dr. PL. Sahu,
Principal Scientific Officer, Head, R&D, Indian Pharmacopoeia
Commission
Impurity standards are very essential for related
substance analysis. Further, it is also important for ensuring the
product quality, he added.
Impurity standards are used to
perform the system suitability, qualitative and quantitative parameters
for compliance to Indian Pharmacopoeia monograph.
The Commission
has created a set of standards for 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. It publishes
official documents for improving quality of medicines by adding new and
updating existing monographs in the form of Indian Pharmacopoeia (IP).
It further promotes rational use of generic medicines by publishing
National Formulary of India, said Dr Sahu.
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