Letrozole Tablets

Type of Posting: 
Revision Bulletin
Posting Date: 
30–Sept–2011
Targeted Official Date: 
01–Oct–2011
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 Letrozole Tablets monograph. The purpose for the revision is to add Dissolution Test 2 for a generic product approved by FDA. In addition, the definition for “L” is added in the Analysis section under Dissolution Test 1 and the number of tablets is specified in the Sample solution under Organic impurities.

The Letrozole Tablets Revision Bulletin supersedes the currently official monograph.  The Revision Bulletin will be incorporated in First Supplement to USP 35–NF 30.

Should you have any questions, please contact Feiwen Mao (301-816-8320 or fm@usp.org).