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IPC clarifies on uniformity of dosage units, elemental impurities & nitrosamine impurities in IP 2022
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Laxmi Yadav, Mumbai
November 04 , 2022
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In a bid to address stakeholders’ concerns about implementation and compliance of new and revised pharmacopoeial text, the Indian Pharmacopoeia Commission (IPC) has come out with clarification on newly added general chapters on uniformity of dosage units, elemental impurities and nitrosamine impurities to Indian Pharmacopoeia (IP) 2022.
IPC published the ninth edition of IP 2022 and the Union minister of health and family welfare released it on July 1, 2022. The IP 2022 contained several new monographs and general chapters and revised several others to meet the current analytical and regulatory requirements.
After the release of IP 2022, IPC has received several enquiries from stakeholders on implementation and compliance of newly introduced general chapters on uniformity of dosage units, elemental impurities and nitrosamine impurities.
In order to address enquiries of stakeholders, IPC came out with clarification on implementation of these general chapters on October 27, 2022.
Dr Rajeev Singh Raghuvanshi, secretary-cum-scientific director, IPC in a clarification stated that IPC has introduced a general chapter on uniformity of dosage units in harmonization with other pharmacopoeias under section 2.54(i) on page 361, Volume I of IP 2022. This chapter is presently introduced in IP 2022 for information and awareness of the stakeholders and is not referred to in the individual monographs and, therefore, remains a non-mandatory requirement. However, stakeholders may adopt this chapter before its implementation is made mandatory by IPC, said Dr Raghuvanshi.
Clarifying implementation of the general chapter on elemental impurities in IP 2022, he said “IPC has introduced a new general chapter on elemental impurities on page 1204, Volume I of IP 2022 for information and awareness of the stakeholders and is not referred to in the individual monographs. Therefore, it remains a non-mandatory requirement. However, stakeholders may adopt and implement this general chapter as an alternative to test on heavy metals as per the provisions of the IP general notices. IPC will gradually replace test on heavy metals in the individual monographs to make elemental impurities mandatory from the next edition of IP i.e. IP 2026.”
The secretary-cum-scientific director in a clarification on implementation of new general chapter on nitrosamine impurities, said “IPC has introduced new general chapter on nitrosamine impurities on page 1210, volume I of IP 2022 for guidance of the stakeholders which is also referred in sartan API monographs of the IP. However, it is expected that stakeholders adopt this general chapter for determining the nitrosamine impurities in other rugs as well, wherever deemed appropriate and necessary.”
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