Type of Posting: Revision Bulletin
Posting Date: 22–Mar–2013
Official Date: 01–Apr–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 and Pseudoephedrine Hydrochloride Extended-Release Tablets monograph. The purpose for the revision is to add Dissolution Test 2 for generic products approved by the FDA. Additionally, a minor editorial change was made under Dissolution Test 1. The text referring to the Acceptance Table 2 was moved to the end of the Tolerances section of Dissolution Test 1.
- The liquid chromatographic procedure in the test for Dissolution Test 2 is based on analyses performed with a Supelco Discovery HS C88 brand of L1 column. The typical retention time for pseudoephedrine and cetirizine are about 3 min and 9 min respectively.
The Cetirizine Hydrochloride and Pseudoephedrine Hydrochloride Extended-Release Tablets Revision Bulletin replaces the currently official monograph. The Revision Bulletin will be incorporated into USP 37–NF 32.
Should you have any questions, please contact Domenick Vicchio, Ph.D. (301-998-6828 or dwv@usp.org).