Type of Posting: Revision Bulletin
Posting Date: 27–Apr–2012
Official Date: 01–May–2012
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 Orally Disintegrating Tablets monograph. The purpose for the revision is to:
- Add Disintegration Test 2 for a generic product approved by the FDA.
- Add Dissolution Test 2 for a generic product approved by the FDA. The liquid chromatographic procedure is based on analyses performed with the Phenomenex Luna C8 brand of L7 column. The typical retention time for alprazolam is 3.2 min.
- Correct the preparation of the Medium in Dissolution Test 1.
The Alprazolam Orally Disintegrating Tablets Revision Bulletin supersedes the monograph in USP 35–NF30, which is scheduled to become official on May 1, 2012. The Revision Bulletin will be incorporated in USP 36–NF 31.
Should you have any questions, please contact Heather Joyce, Ph.D. (301-881-0666 x8442 or hrj@usp.org).