Type of Posting: Revision Bulletin
Posting Date: 28–Mar–2014
Official Date: 01–Apr–2014
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 5 for drug products approved by the FDA.
- Dissolution Test 5 was validated using a Zorbax Eclipse XDB-C8 brand of L7 column. The typical retention time for alprazolam is about 5.5 min.
- Additionally, minor editorial changes have been made to update the monograph to current USP style.
The Alprazolam Extended-Release Tablets Revision Bulletin supersedes the currently official Alprazolam Extended-Release Tablets monograph and replaces the monograph in the Revision Bulletin posted on July 26, 2013, which became official August 1, 2013 and is being incorporated into the First Supplement to USP 37–NF 32. This Revision Bulletin will be incorporated in USP 38–NF 33.
Should you have any questions, please contact Heather Joyce (301–998-6792 or HRJ@usp.org).