Type of Posting: Revision Bulletin
Posting Date: 30–May–2014
Official Date: 01–Jun–2014
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 Norethindrone Tablets monograph. The purpose for the revision is to add Dissolution Test 3 for a drug product approved by the FDA.
The liquid chromatographic procedure used in Dissolution Test 3 is based on analyses performed with a Zorbax Exclipse XDB brand of L1 column manufactured by Agilent. The typical retention time for norethindrone is about 4 minutes.
Additionally, minor editorial changes have been made to update the monograph to current USP style.
The Norethindrone Tablets Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated into USP 38–NF 33.
Should you have any questions, please contact Mary P. Koleck (301-230-7420 or mpk@usp.org).