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Pioglitazone and Metformin Hydrochloride Tablets

Type of Posting: Revision Bulletin

Posting Date: 25–Jul–2014

Official Date: 01–Aug–2014

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 Metformin Hydrochloride Tablets monograph. The purpose of this revision is to add Dissolution Test 2 for an FDA approved generic product.

  • The HPLC procedure in Dissolution Test 2 is based on analyses conducted with the Zorbax XDB C18 brand of L1 column.
  • The typical retention time for metformin is about 4 min and for pioglitazone is about 9 min.

The Pioglitazone and Metformin Hydrochloride Tablets Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in the First Supplement to USP 38–NF 33.

Should you have any questions, please contact Elena Gonikberg, Ph.D. (301-816-8251 or eg@usp.org).