Proposed Revision of USP Chapter <711> Dissolution Canceled

Recommendation

7/8 May 2024

Extractables & Leachables - Live Online Training
Challenges and Solutions for Packaging and Single Use Systems

As previously reported, the Dosage Forms Expert Committee intends to revise USP General Chapter <711> Dissolution. "The purpose of this revision is to replace the existing USP Reference Standard Prednisone Tablets with a new USP Dissolution Performance Verification Standard – Prednisone RS, to qualify the Dissolution Apparatus 1 (basket) and Dissolution Apparatus 2 (paddle)."

In a new Notice of Intent to Revise posted on 27 May 2022, it was announced that based on the comments received, the previously proposed revision published in Pharmacopeial Forum 48(2) in March 2022, has been canceled. This Notice replaces the previous Notice of Intent to Revise posted on 29 October 2021.

The new Notice states that the collaborative testing of the new Reference Standard has been completed. The results are currently under evaluation.

It is expected that the new USP Reference Standard will be released in late 2022. The time frame for the implementation of the revised chapter has been postponed. It is anticipated that the proposed revision to General Chapter <711> will be published as an Interim Revision Announcement in Pharmacopeial Forum 48(6) in November 2022, with the comment period ending on 31 January 2023. The earliest date to become official would then be 01 May 2023.