Type of Posting: Notice of Intent to Revise
Posting Date: 29–Jul–2011
Targeted Official Date: Interim Revision Announcement, 01–May–2012
Expert Committee: Monographs—Small Molecules 4
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 4 Expert Committee intends to revise the the Levalbuterol Hydrochloride monograph as follows:
- Under Organic Impurities test, the limit of total unspecified impurities is being deleted.
- Enantiomeric Purity and Chiral Identity test is being revised to add clarity to the monograph.
- Identification section is strengthened by adding a second test based on retention time agreement between Standard and Sample solutions in the Enantiomeric Purity and Chiral Identity test.
It is anticipated that the revision will be published as a Proposed Interim Revision Announcement in PF 37(6) [Nov.–Dec. 2011] pursuant to section 7.02 of the Rules and Procedures.
Should you have questions, please contact Ravi Ravichandran, Ph.D., Principal Scientific Liaison to the Monographs—Small Molecules 4 Expert Committee (301-816-8330 or firstname.lastname@example.org).