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Metoprolol Succinate Extended-Release Tablets

Type of Posting: Revision Bulletin

Posting Date: 27–Jul–2012

Official Date: 01–Aug–2012

Archive Date: 09–Feb–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 Metoprolol Succinate Extended-Release Tablets monograph. The purpose for the revision is to add Dissolution Test 2 for a generic product. The liquid chromatographic procedure in the Dissolution Test 2 is based on analyses performed using a Superspher 60 RP-Select B column of packing L7. The typical retention time for metoprolol is about 2.1-3.1 min. A minor editorial change is made in Dissolution Test 1.

The Metoprolol Succinate Extended-Release Tablets Revision Bulletin supersedes the currently official monograph. This Revision Bulletin will be incorporated in the First Supplement to USP 36–NF 31.

Should you have any questions, please contact Sujatha Ramakrishna Ph.D., M.B.A. (301-816-8349 or sxr@usp.org).