Draft of Harmonized USP Chapter <701> Disintegration Published for Comments
![Statistical Simulations for Enhanced Understanding of Analytical Performance - Live Webinar](files/eca/userImages/training.img/Z-ECA-Webinar-Statistical-Simulations.jpg)
Recommendation
Monday, 9 September 2024 14.00 - 16.00 h
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.
Related GMP News
24.07.2024FDA Warning Letter to Chinese OTC Manufacturer for Lack of Analytical Test Data
10.07.2024Pharmeuropa: Two Revised Chapters on Dissolution Testing published for comments
03.07.2024FDA Warning Letter: GMP Requirements also apply to HPLC Analyses for Internal Use
12.06.2024NMPA Announcement on Application of ICH Q2(R2) and Q14 Principles
22.05.2024Q&As from the Live Online Training "Introduction to the AQCG's new AIQSV Guide" - Part 1
22.05.2024FDA Warning Letter to Contract Testing Laboratory in Uruguay due to Data Integrity Violations