Type of Posting: Revision Bulletin
Posting Date: 28–Jan–2011
Official Date: 01–Feb–2011
Expert Committee: Monographs—Small Molecules 2
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 Amlodipine Besylate Tablets. The purpose for the revision is to add two new formulation-specific impurities, amlodipine lactose adduct and amlodipine glucose/galactose adduct having an acceptance criterion of NMT 0.5% each, under Organic impurities section for a generic product.
The Amlodipine Besylate Tablets Revision Bulletin supersedes the currently official Amlodipine Besylate Tablets 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 (301-816-8349 or sxr@usp.org).