Type of Posting: Notice of Intent to Revise
Posting Date: 25-Apr-2025
Targeted Official Date: TBD
Expert Committee: Small Molecules 5
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 5 Expert Committee intends to revise the Estradiol monograph.
Based on the comments received, the Small Molecules 5 Expert Committee proposes to delete the old legacy test for Melting range from the Estradiol monograph as the current monograph contains sufficient tests to ensure the quality of the drug substance.
It is anticipated that the proposed revision will be published using a suitable revision vehicle pursuant to the Rules and Procedures, at a date to be determined.
Should you have any questions, please contact Andrea Carney, Senior Manager (AFC@usp.org).