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Telmisartan and Hydrochlorothiazide Tablets

Type of Posting: Revision Bulletin

Posting Date: 27–Mar–2015

Official Date: 01–Apr–2015

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 Telmisartan and Hydrochlorothiazide Tablets monograph. The purpose of the revision is to include Dissolution Test 2 to be consistent with the FDA approved specifications.

The HPLC procedure in Dissolution Test 2 is based on analyses performed using an Inertsil ODS-3V brand of L1 column. The typical retention times for Hydrochlorothiazide and Telmisartan are about 3 minutes and 7 minutes respectively.

Minor editorial changes have been made to update the monograph to the current USP style

The Telmisartan and Hydrochlorothiazide Tablets Revision Bulletin supersede the currently official monograph. This Revision Bulletin will be incorporated in the USP 39–NF 34.

Should you have any questions, please contact Sujatha Ramakrishna Ph.D., MBA (301-816-8349 or