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Revision Bulletin

Metformin Hydrochloride Extended–Release Tablets

Posting Date:

 29 September 2009; updated 18 March 2010

 

Official Date:

1 November 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 ).

Download the Metformin Hydrochloride Extended–Release Revision Bulletin  (543KB).