Type of Posting: Revision Bulletin
Posting Date: 31–Jan–2013
Official Date: 01–Feb–2013
Archive Date: 09–Feb–2015
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 5 and Test 6 for new generic products approved by the FDA.
- Dissolution Test 5 was validated using an Xterra RP18 brand of C1 column. The typical retention time for valproic acid is about 4.4 min.
- Dissolution Test 6 was validated using an Inertsil C8 brand of C7 column manufactured by GL Sciences. The typical retention time for valproic acid is about 6 min.
Additionally, the pore size of the filter used in Dissolution Test 4 for the preparation of the Acid stage sample solution and the Buffer stage sample solution is corrected from 45-µm to 0.45-µm.
The Divalproex Sodium Extended-Release Tablets Revision Bulletin supersedes the currently official monograph and replaces the monograph in the Revision Bulletin posted on April 27, 2012, which became official on May 1, 2012 and is incorporated in USP 36–NF 31. This Revision Bulletin will be incorporated in the Second Supplement to USP 36–NF 31.
Should you have any questions, please contact Heather Joyce, Ph.D. (301-881-0666 x8442 or hrj@usp.org).