Divalproex Sodium Extended-Release Tablets

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).

Download the Divalproex Sodium Extended-Release Tablets Revision Bulletin