New Proposal for USP Chapter <711> Dissolution Published for Comments

Recommendation

Monday, 29 April 2024 10.00 - 16.00 h

Introduction to the AQCG’s new ECA Guide for an Integrated Lifecycle Approach to Analytical Instrument Qualification and System Validation
Includes USP Speaker Update on the Analytical Procedure Lifecycle

In the Pharmacopeial Forum, PF 48(6), a proposal for a revised USP Chapter <711> Dissolution was published. The proposal is based on the version of the chapter official as of 01 May 2022. The previous proposal published in PF 48(2) in March 2022 was canceled.

The purpose of the revision is to replace USP Prednisone Tablets RS with a new Reference Standard, USP Dissolution Performance Verification Standard-Prednisone RS, to qualify the Dissolution Apparatus 1 and Apparatus 2.

In the briefing notes to the revised chapter, it is pointed out that "the use of USP Prednisone Tablets RS in this general chapter is referenced in The Dissolution Procedure—Development and Validation <1092>. This reference will be updated, using a suitable accelerated revision process, to become official at the same date as this revision."

Comments can be submitted until 31 January 2023. In the absence of significant adverse comments, the new version will be implemented via an Interim Revision Announcement with an official date of 01 May 2023.

The draft of the revised chapter is available on PF Online.