Type of Posting: Revision Bulletin
Posting Date: 31–Jan–2013
Official Date: 01–Feb–2013
Archive Date: 09–Feb–2015
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 Cetirizine Hydrochloride Tablets monograph. The purpose for the revision is to:
- Widen the cetirizine lactose ester impurity limit from NMT 0.40% to NMT 0.5%, and the total impurity limits from NMT 0.8% to NMT 1% to match FDA approved limits.
The Cetirizine Hydrochloride Tablets Revision Bulletin supersedes the currently official monograph and replaces the monograph in the Revision Bulletin posted on July 27, 2012, which became official August 1, 2012 and is being incorporated into the First Supplement to USP 36–NF31. This Revision Bulletin will be incorporated in the Second Supplement to USP 36–NF31.
Should you have any questions, please contact Domenick Vicchio, Ph.D. (301-998-6828 or dwv@usp.org).