Type of Posting: Revision Bulletin
Posting Date: 25–Jul–2014
Official Date: 01–Aug–2014
Expert Committee: Monographs—Small Molecules 2
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 2 Expert Committee has revised the Verapamil Hydrochloride Extended-Release Tablets monograph. The purpose for the revision is to add Dissolution Test 7 for drug products approved by the FDA.
- Dissolution Test 7 was validated using a Hypersil BDS-C8 brand of L7 column. The typical retention time for Verapamil is about 4.2 min.
- Additionally, minor editorial changes have been made to update the monograph to current USP style.
The Verapamil Hydrochloride Extended-Release Tablets Revision Bulletin supersedes the currently official Verapamil Hydrochloride Extended-Release Tablets monograph and is being incorporated into the First Supplement to USP 38–NF 32.
Should you have any questions, please contact Sujatha Ramakrishna Ph.D., MBA (301–816–8349 or sxr@usp.org).