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Levalbuterol Inhalation Solution

Type of Posting: Notice of Intent to Revise

Posting Date: 07–Feb–2014

Targeted Official Date: Interim Revision Announcement, 01–Nov–2014

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 Levalbuterol Inhalation Solution monograph. USP is unable to maintain a reliable supply of the USP Levalbuterol Related Compound G RS utilized in the current test for Organic Impurities. The purpose of this revision is to eliminate the need for this Reference Standard. USP Levalbuterol Related Compound G RS is used to accomplish two specific purposes. The first purpose is to identify this degradation product. The second purpose is to establish that the system is suitably precise (relative standard deviation requirement).

The remaining system suitability requirements are sufficient to establish that the chromatographic system is suitable. Removal of USP Levalbuterol Related Compound G RS from the monograph should present no safety concerns since it is a qualitative reference standard and provides no information regarding the amount of impurity present in the article.

It is anticipated that the revision will be published as a Proposed Interim Revision Announcement in PF 40(3) [May–Jun 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 Ravi Ravichandran, Principal Scientific Liaison to the Monographs—Small Molecules 4 Expert Committee (301-816-8330 or