Type of Posting: Revision Bulletin
Posting Date: 30–May–2014
Targeted Official Date: 01–Jun–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 Tramadol Hydrochloride Extended-Release Tablets monograph. The purpose for the revision is to add Dissolution Test 2 for drug products approved by the FDA. Additionally, minor editorial changes have been made to update the monograph to current USP style.
The Tramadol Hydrochloride Extended-Release Tablets Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated into USP 38–NF 33.
Should you have any questions, please contact Hillary Cai (301–230-3379 or hzc@usp.org).