Indian Pharmacopoeia Commission clarifies on three new general chapters introduced in Indian Pharmacopoeia 2022 which are on Uniformity of Dosage Units, Elemental Impurities and Nitrosamine Impurities.
Indian Pharmacopoeia Commission (IPC) has published the Indian Pharmacopoeia (IP) 2022 and Hon ble Union Health Minister released the 9th edition of IP 2022 in July, 2022 in Vigyan Bhawan. New Delhi.
In IP 2022, several new monographs and general chapters have been introduced while several others are revised to meet the current analytical and regulatory requirements.
After the release of IP 2022, IPC has received several enquiries from the stakeholders on implementation and compliance of new and/or revised pharmacopoeial text. In order to address the enquiries of the stakeholders, clarification on three general chapters released by IPC.
IPC has introduced a general chapter on Uniformity of Dosage Units in harmonization with other pharmacopoeias under 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 chater before its implementation is made mandatory by IPC.
Another general chapter on Elemental Impurities introduced in Volume I of IP 2022 for information and awareness of the stakeholders and is not referred in the individual monographs. Therefore, it remains 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).
A new general chapter on Nitrosamine Impurities introduced in 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 drugs as well, wherever deemed appropriate and necessary.
