Type of Posting: Revision Bulletin
Posting Date: 27–Jul–2012
Official Date: 01–Aug–2012
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 ethanol impurity limit from NMT 0.15% to NMT 0.2% to match FDA approved limits.
- Add Dissolution Tests 2 and 3 for other products approved by the FDA, and to make a correction in the calculation under Dissolution Test 1.
The Cetirizine Hydrochloride Tablets Revision Bulletin replaces the monograph in the First Supplement to USP 35–NF 30, which is scheduled to become official August 1, 2012. The Revision Bulletin will be incorporated in the First Supplement to USP 36–NF 31.
Should you have any questions, please contact Domenick Vicchio, Ph.D. (301-998-6828 or dwv@usp.org).