Type of Posting: Notice of Intent to Revise
Posting Date: 27–Dec–2013
Targeted Official Date: Interim Revision Announcement, 01–Sep–2014
Archive Date: 11–MAR–2014
Expert Committee: Monographs—Small Molecules 2
In accordance with section 7.05(c) of the 2010–2015 Rules and Procedures of the Council of Experts, this is to provide notice that the USP Monographs-Small Molecules 3 Expert Committee intends to revise the Chlorhexidine Acetate monograph. USP will not be able to maintain a reliable supply of the USP Chlorhexidine Related Compounds RS utilized in the current test for Organic Impurities. The purpose of this revision is to eliminate the need for this Reference Standard by introducing a new, more selective procedure for Organic Impurities that is similar to the procedure in the Pharmeuropa 25.2 proposal for Chlorhexidine Diacetate. This procedure employs a new USP Chlorhexidine System Suitability Mixture RS. Use of the accelerated revision process is intended to provide a modern procedure supported by the new USP Reference Standard before the supply of the USP Chlorhexidine Related Compounds RS is exhausted.
Additionally, USP is taking this opportunity to streamline and update other sections of the monograph, and make it consistent with current USP editorial style.
It is anticipated that the revision will be published as a Proposed Interim Revision Announcement in PF 40(2) [Mar–Apr 2014] pursuant to section 7.02 of the Rules and Procedures. Interested parties are encouraged to submit comments on the proposal.
Should you have questions, please contact Morgan Puderbaugh, Scientific Liaison to the Monographs–Small Molecules 3 Expert Committee (301-998-6833 or mxp@usp.org).