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Metformin Hydrochloride Extended-Release Tablets

Type of Posting: Revision Bulletin

Posting Date: 30–Jul–2010

Official Date: 01–Sept–2010

Expert Committee: Monographs—Small Molecules 3

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 3 Expert Committee has revised the monograph for Metformin Hydrochloride Extended-Release Tablets. The purpose for the revision is to add a Dissolution Test 11 for a new product approved by FDA.

The Metformin Hydrochloride Extended-Release Tablets Revision Bulletin supersedes the currently official Metformin Hydrochloride Extended-Release Tablets. The Revision Bulletin will be incorporated in USP 34–NF 29.

Should you have any questions, please contact Margareth Marques (301-816-8106 or mrm@usp.org).