Alprazolam Extended-Release Tablets

Type of Posting: 
Revision Bulletin
Official Date: 
01–Aug–2013
Expert Committee: 
Monographs—Small Molecules 4
Reason for Revision: 
Compliance

In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Alprazolam Extended-Release Tablets monograph. The purpose for the revision is to add Dissolution Test 4 for a product approved by the FDA.

The HPLC procedure in Dissolution Test 4 is based on analyses conducted with a Hypersil BDS C18 column brand of L1 column. The typical retention time for alprazolam is about 7 min.

The Alprazolam Extended-Release Tablets Revision Bulletin supersedes the currently official Alprazolam Extended-Release Tablets monograph. The Revision Bulletin will be incorporated in the First Supplement to USP 37–NF 32.

Should you have any questions, please contact H. Joyce, Ph.D. (301-998-6792 or hrj@usp.org).