Draft of Harmonized USP Chapter <701> Disintegration Published for Comments

Recommendation

26/27 June 2024
Hamburg, Germany

Dissolution Testing
Development / Quality Control and in vivo Relevance

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.

PDG Harmonized Document

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 Japanese Pharmacopoeia (JP),
• the European Pharmacopoeia (Ph. Eur.),
• and the United States Pharmacopeia (USP).

The PDG works on pharmacopoeial harmonization of excipient monographs and general chapters.

Revised USP Chapter <701> Disintegration

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:

• Introduction.
• Apparatus: clarified Test A Basket-Rack Assembly and inclusion of the Test B Basket-Rack Assembly.

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.