Type of Posting: Revision Bulletin
Posting Date: 26–Sep–2014
Official Date: 01–Oct–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 Bupropion Hydrochloride Extended-Release Tablets. The purpose for the revision is to add Dissolution Test 14 for a drug product approved by the FDA with different conditions and tolerances than the existing dissolution tests. Additionally, the chemical name for USP Bupropion Hydrochloride Related Compound F RS is revised for consistency with the chemical name on the Reference Standard label.
The Bupropion Hydrochloride Extended-Release Tablets Revision Bulletin supersedes the currently official monograph and replaces the version in the Second Supplement to USP 37–NF 32 which is scheduled to become official on December 1, 2014. The Revision Bulletin will be incorporated in the First Supplement to USP 38–NF 33.
Should you have any questions, please contact Heather Joyce, Ph. D., Scientific Liaison (301-998-6792 or hrj@usp.org).