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Indian Pharmacopoeia Commission launches 10 new impurities standards
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Shardul Nautiyal, Mumbai
December 29 , 2022
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The Indian Pharmacopoeia Commission (IPC) has launched 10 new impurities standards for effective quality control analysis of pharmaceutical products in the country. With this, IPC will have a total of 410 impurities standards in its database which is available for sale at www.ipc.gov.in for drug manufacturing companies and testing labs in the country.
“We are planning to increase the number of impurities standards in our IPC product catalogue and have set the target of having 500 Impurities Standards by March 2023. Manufactures and other stakeholders used to source these standards from the British Pharmacopoeia or the US Pharmacopoeia earlier but now is making them available through IPC at standardized rates under one platform,” according to Dr Rajiv Singh Raghuvanshi, secretary-cum-scientific director, IPC.
The names of the impurities standards are dolutegravir-4-fluoro impurity, ethyl paraben, fumaric acid (Lamivudine and Tenofovir tablets), Ketorolac -1- hydoxy analog, mesalazine impurity F, fumaric acid (Maleic Acid), methotrexate impurity A, risperidone trans -N-oxide, terbinafine related compund B and fumaric acid (Quetiapine Fumarate).
IPC in the month of July had launched the ninth edition of the Indian Pharmacopoeia (IP).
IP is recognized as the official book of standards for the drugs being manufactured and/or marketed in India. IP contains a collection of authoritative procedures of analysis and specifications of drugs for their identity, purity and strength. The standards of the IP are authoritative in nature and are enforced by the regulatory authorities for ensuring the quality of drugs in India.
During quality assurance and at the time of dispute in the court of law, the IP standards are legally acceptable. The Standards prescribed in the IP are to establish the compliance with regulatory requirements on an article.
The determination of unwanted compounds in pharmaceuticals is critical to addressing the safety, quality, and purity of drug substances and finished products. Impurities can affect the safety and efficacy of pharmaceuticals and biologic drugs, resulting in the potential recall of marketed drugs or the extension of drug development timelines, as these unwanted chemicals remain with the drug formulation or active pharmaceutical ingredient (API).
Impurities can be introduced from a variety of sources, from API and/or excipient degradation, to manufacturing processes, including process impurities, process aids and residual solvents, or from container-closure contact and storage. International Council for Harmonization (ICH) Q3A – Q3E guidance outlines five primary categories for impurities associated with pharmaceuticals, which consist of impurities in new drug substances, impurities in new drug products, residual solvents, elemental impurities, and extractables and leachables (E&L).
IPC is an autonomous institution under the Union Health Ministry to deal with matters relating to timely publication of the Indian Pharmacopoeia (IP) which is the official book of standards for drug to specify the standards of identity, purity and strength of the drugs imported, manufactured for sale, stocked or exhibited for sale or distributed in India.
An impurity standard is any component of the pharmaceutical product which is not the chemical entity defined as the active substance or an excipient in the product meant for identifying the impurity as a reference. Drug Impurities are unwanted chemicals that remain with the active pharmaceutical ingredients or develop during formulation or upon aging of both API and formulation which is subject of analysis and rigorous testing for quality assurance.
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