Levalbuterol Hydrochloride

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 rr@usp.org).