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Levalbuterol Inhalation Solution

Type of Posting: Revision Bulletin

Posting Date: 30¬–May–2014

Targeted Official Date: 01–Jun–2014

Expert Committee: Monographs—Small Molecules 4

Reason for Revision: Correction of test

In accordance with the Rules and Procedures of the 2010-2015 Council of Experts, the Monographs—Small Molecules 4 Expert Committee has revised the Levalbuterol Inhalation Solution monograph. The purpose for the revision is to eliminate the need for USP Levalbuterol Related Compound G RS, because USP is unable to maintain a reliable supply of the USP Levalbuterol Related Compound G RS which is utilized in the current test for Organic Impurities. In addition, the name in Table 3 of Organic Impurities test USP Levalbuterol Related Compound G has been replaced with 5-hydroxyalbuterol. The table has been reformatted to be consistent with the current USP style guide.

This Levalbuterol Inhalation Solution Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated into USP 38–NF 33.

Should you have any questions, please contact Ravi Ravichandran, Ph.D. (301-816-8330, rr@usp.org).