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Metformin Hydrochloride Extended-Release Tablets

Type of Posting: Revision Bulletin

Posting Date: 29–Sept–2009; updated 18–Mar–2010

Official Date: 01–Nov–2009

Expert Committee: Biopharmaceutics

In accordance with the Rules and Procedures of the 2005–2010 Council of Experts, the Biopharmaceutics Expert Committee has revised the equation in Dissolution Test 3 and includes a new Dissolution Test for a new generic version of Metformin Hydrochloride Extended-Release Tablets approved by the Food and Drug Administration.

Metformin Hydrochloride Extended-Release Tablets Revision Bulletin supersedes the currently official monograph and will be incorporated into the First Supplement to the USP 33–NF 28 Reissue.

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