Type of Posting: Revision Bulletin
Posting Date: 22–Mar–2013
Official Date: 01–May–2013
Archive Date: 09–Feb–2015
Expert Committee: Monographs—Small Molecules 4
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Alfuzosin Hydrochloride Extended-Release Tablets monograph. The purpose for the revision is to add Dissolution Tests 3, 4, and 5 for other products approved by the FDA.
- The liquid chromatographic procedure in the test for Dissolution Test 5 is based on analyses performed with a Hypersil BDS C18 brand of L1 column. The typical retention time for alfuzosin is about 5 min.
The Alfuzosin Hydrochloride Extended-Release Tablets Revision Bulletin replaces the monograph in USP 36–NF 31, which is scheduled to become official May 1, 2013. The Revision Bulletin will be incorporated into USP 37–NF 32.
Should you have any questions, please contact Domenick Vicchio, Ph.D. (301-998-6828 or dwv@usp.org).