In the Pharmacopeial Forum, PF 49(3), a proposal of a revised USP General Chapter <711> Dissolution has been published for comments. The background to the publication is the efforts of international harmonization of monographs and general analytical methods of the European, Japanese, and United States pharmacopeias.
The PDG works on pharmacopoeial harmonization of excipient monographs and general chapters.
Revised USP Chapter <711> Dissolution
The now published proposal is based on the version of the USP chapter official since 01 May 2023. It represents the official inquiry stage 2A of Revision 5 to the PDG harmonized document.
According to the briefing notes, the draft includes changes in the following sections: