Type of Posting: Revision Bulletin
Posting Date: 28–Mar–2014
Official Date: 01–April–2014
Expert Committee: Monographs—Small Molecules 2
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 2 Expert Committee has revised the Valsartan and Hydrochlorothiazide Tablets monograph. The purpose of the revision is to add Dissolution Test 2 for a FDA approved generic product. Several minor editorial changes have been made to update the monograph to the current USP style.
The HPLC procedure in Dissolution Test 2 is based on analyses conducted with an Inertsil ODS-2 brand of L1 column. The typical retention time for Valsartan is about 8 min and for Hydrochlorothiazide is about 2 min.
The Valsartan and Hydrochlorothiazide Tablets Revision Bulletin supersede the currently official monograph. This Revision Bulletin will be incorporated in to USP 38–NF 33.
Should you have any questions, please contact Sujatha Ramakrishna, Ph.D., MBA (301-816-8349 or sxr@usp.org).