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Divalproex Sodium Extended-Release Tablets

Type of Posting: Revision Bulletin

Posting Date: 27–Apr–2012

Official Date: 01–May–2012

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 monograph. The purpose for the revision is to:

  • Add Dissolution Test 4 for a generic product approved by the FDA. Dissolution Test 4 was validated using a Kromasil C18 brand of L1 column. The typical retention time for valproic acid is about 3.9 min.
  • Clarify the sampling times in Dissolution Test 2 and Dissolution Test 3.

The Divalproex Sodium Extended-Release Tablets Revision Bulletin supersedes the currently official monograph and replaces the monograph in the Revision Bulletin posted on 26 August 2011 which became official 01 September 2011 and is incorporated in the First Supplement to USP 35–NF 30. This Revision Bulletin will be incorporated in USP 36–NF 31.

Should you have any questions, please contact Heather Joyce, Ph.D. (301-881-0666 x8442 or hrj@usp.org).