Type of Posting: Revision Bulletin
Posting Date: 29–Jun–2012
Official Date: 01–Jul–2012
Expert Committee: Monographs—Small Molecules 3
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 3 Expert Committee has revised the Metformin Hydrochloride Extended–Release Tablets monograph. The purpose for the revision is to add Dissolution Test 12 for a product approved by the FDA.
Minor editorial changes have been made under Dissolution tests. When Acceptance Table 2 is specified under Tolerances, a reference to the General Chapter <711> Dissolution is added, and the text referring to the Acceptance Table 2 is moved to the end of the Tolerances section for each Dissolution test.
The Metformin Hydrochloride Extended–Release Tablets Revision Bulletin supersedes the currently official Metformin Hydrochloride Extended–Release Tablets monograph. The Revision Bulletin will be incorporated in USP 36–NF 31.
Should you have any questions, please contact Elena Gonikberg, Ph.D. (301-816-8251 or eg@usp.org).