Type of Posting: Revision Bulletin
Posting Date: 26–Aug–2011
Official Date: 01–Sept–2011
Expert Committee: Monographs—Small Molecules 4
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Divalproex Sodium Extended-Release Tablets. The purpose for the revision is to:
- Add Dissolution Test 3 for a generic product approved by FDA.
- Revise Dissolution Test 1 to make the use of sinkers optional and correct the acceptance for Acid stage.
- Correct the preparation of the Buffer stage medium and the Procedure under Dissolution Test 2.
The Divalproex Sodium Extended-Release Tablets Revision Bulletin supersedes the currently official Divalproex Sodium Extended-Release Tablets monograph. The Revision Bulletin will be incorporated in the First Supplement to USP 35–NF 30.
Should you have any questions, please contact Ravi Ravichandran, Ph.D. (301-816-8330 or rr@usp.org).