26/27 June 2024
Hamburg, Germany
In the Pharmacopeial Forum, PF 49(5), a proposal of a revised USP General Chapter <701> Disintegration has been published for comments. The comments period runs from 01 September to 30 November 2023.
The chapter was updated as part of the process of international harmonization of the European, Japanese, and United States pharmacopeias.
The proposal represents the official inquiry stage 2A of Revision 5 (version 1) to the Pharmacopeial Discussion Group (PDG) harmonized document. The PDG, which was created in 1989, brings together
The PDG works on pharmacopoeial harmonization of excipient monographs and general chapters.
According to the briefing notes, the new proposal is based on the version of the USP chapter official as of 01 May 2020. It "includes changes in the following sections:
Additionally, minor editorial changes have been made to update the chapter to current USP style."
The draft chapter is available on PF Online via the USP Website Access Point.