Type of Posting: Revision Bulletin
Posting Date: 22–Nov–2013
Official Date: 01–Dec–2013
Archive Date: 09–Feb–2015
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 Pioglitazone and Glimepiride Tablets monograph. The purpose of this revision is to add Dissolution Test 2 for a product approved by the FDA.
The HPLC procedure in Dissolution Test 2 is based on analyses conducted with a XBridge C18 brand of L1 column. The typical retention times for the pioglitazone and glimepiride peaks are about 2.7 and 5.3 min, respectively.
The Pioglitazone and Glimepiride Tablets Revision Bulletin replaces the monograph in the Second Supplement to USP 36–NF 31, which is scheduled to become official December 1, 2013. The Revision Bulletin will be incorporated in the Second Supplement to USP 37–NF 32.
Should you have any questions, please contact E. Gonikberg, Ph.D. (301-816-8251 or eg@usp.org).