Estradiol Transdermal System

Type of Posting: 
Revision Bulletin
Posting Date: 
29–Apr–2011
Official Date: 
01–May–2011
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 Estradiol Transdermal System monograph. The purpose for the revision is to widen the Assay acceptance criteria from 90.0%–110.0% to 85.0%–120.0% to accommodate the sponsor's FDA-approved specifications.

The Estradiol Transdermal Systems Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in USP 35–NF 30

Should you have any questions, please contact Domenick Vicchio, Ph.D. (301-998-6828 or dwv@usp.org).