Type of Posting: Revision Bulletin
Posting Date: 28–Jan–2011
Official Date: 01–Feb–2011
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 monograph for Carvedilol. The purpose of this revision is to add a new specified impurity, carvedilol dimer (relative retention time = 0.70) with a limit of NMT 0.15% to the Table 1 under the section for Organic impurities, Procedure 1. The limit of total impurities remains unchanged.
The Carvedilol Revision Bulletin supersedes the currently official Carvedilol monograph. The Revision Bulletin will be incorporated in the Second Supplement to USP 34–NF 29.
Should you have any questions, please contact Sujatha Ramakrishna, Ph.D. (301-816-8349 or sxr@usp.org).