Type of Posting: Revision Bulletin
Posting Date: 28–Sep–2012
Official Date: 01–Oct–2012
Expert Committee: Monographs—Small Molecules 3
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 3 Expert Committee has revised the Isotretinoin Capsules monograph. The purpose for the revision is to add Dissolution Test 4 for a generic product approved by FDA.
The liquid chromatographic procedure used in the Dissolution Test 4 is based on analyses performed with Thermo Hypersil ODS brand of L1 column. The typical retention time for isotretinoin is about 7 min.
The Isotretinoin Capsules Revision Bulletin supersedes the currently official Isotretinoin Capsules monograph. The Revision Bulletin will be incorporated in the First Supplement to USP 36–NF 31.
Should you have any questions, please contact Feiwen Mao (301-816-8320 or fm@usp.org).