Type of Posting: Notice of Intent to Revise
Posting Date: 28–Dec–2012
Targeted Official Date: Revision Bulletin, 29–Mar–2013
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 2 Expert Committee intends to revise the Esmolol Hydrochloride monograph. The purpose of the revision is to update the Organic Impurities section to include a new process-specific impurity and also to update the acceptance criteria for several individual and total impurities based on FDA approved specifications.
It is anticipated that the proposed revision will be published as a Revision Bulletin at a date yet to be determined, pursuant to section 7.02 of the Rules and Procedures.
Should you have questions, please contact Sujatha Ramakrishna, Ph.D., M.B.A., Senior Scientific Liaison to the Expert Committee (301-816-8349 or SXR@usp.org).