Last Updated on October 9, 2024 by The Health Master
Download IPC Notice dt 27-10-2022 Clarification on uniformity of dosage units & impurities in IP 2022: In a bid to address stakeholders’ concerns about the implementation and compliance of new and revised pharmacopoeial text, the Indian Pharmacopoeia Commission (IPC) has come out with a clarification on newly added general chapters on uniformity of dosage units, elemental impurities, and nitrosamine impurities to Indian Pharmacopoeia (IP) 2022 vide its notice dated 27-10-2022.
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 the implementation and compliance of newly introduced general chapters on uniformity of dosage units, elemental impurities and nitrosamine impurities.
In order to address the enquiries of stakeholders, IPC came out with a clarification on the 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 tests 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 the implementation of a new general chapter on nitrosamine impurities, said “IPC has introduced a new general chapter on nitrosamine impurities on page 1210, volume I of IP 2022 for the 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.”
Latest Circulars: (IPC) Indian Pharmacopoeia Commission
Latest Notifications regarding Pharmaceuticals
Latest on National Formulary of India (NFI)
USFDA gives approval for Glycopyrrolate injection
NPPA panel recommends retail price fixation for Atorvastatin and Bempedoic acid
USFDA gives final approval for Mesalamine extended-release capsules
NPPA fixes price of 272 new drugs in the first six months of 2022-23
Govt constitutes 7 member panel to prepare ‘National Drugs Database’
DCGI to SDCs: Accept hard copy of application for registration of Medical Devices
USFDA issues Form 483 with 5 observations to Lupin
IPC introduces draft amendment to microbial contamination in IP 2022
USFDA issues Form 483 with one Observation to Laurus Labs
Latest Notifications regarding Pharmaceuticals
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos by The Health Master, click on the below YouTube icon:
For informative videos on Medical Store / Pharmacy, click on the below YouTube icon:
For informative videos on the news regarding Pharma / Medical Devices / Cosmetics / Homoeopathy etc., click on the below YouTube icon:
For informative videos on consumer awareness, click on the below YouTube icon:
