Type of Posting: Revision Bulletin
Posting Date: 22–Nov–2013
Official Date: 01–Dec–2013
Archive Date: 09–Feb–2015
Expert Committee: Monographs—Small Molecules 2
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 2 Expert Committee has revised the Isosorbide Mononitrate Extended-Release Tablets monograph. The purpose of this revision is to include Dissolution test 4 and Dissolution test 5 to accommodate the FDA approved Tolerances for two newly approved generic products.
The HPLC procedure in Dissolution Test 4 is based on analyses conducted with a Zorbax eclipse XDB column brand of L1 column. The typical retention time for isosorbide mononitrate is about 4.5 min.
The HPLC procedure in Dissolution Test 5 is based on analyses conducted with a Lichrosphere RP18 column brand of L1 column. The typical retention time for isosorbide mononitrate is about 4.6 min.
The Isosorbide Mononitrate Extended-Release Tablets Revision Bulletin supersedes the currently official monograph. This Revision Bulletin will be incorporated in Second Supplement to USP 37–NF 32.
Should you have any questions, please contact Sujatha Ramakrishna Ph.D., MBA (301-816-8349 or sxr@usp.org).