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Levalbuterol Inhalation Solution

Type of Posting: Notice of Intent to Revise
Posting Date: 22-Apr-2022
Targeted Official Date: 01-Nov-2022; Interim Revision Announcement
Expert Committee: Small Molecules 5

In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 5 Expert Committee intends to revise the Levalbuterol Inhalation Solution monograph.

A revision to the test for Organic Impurities is necessary to address a reference material issue and ensure continuity of supply. Based on supporting data, the Expert Committee proposes to revise the preparation of the System suitability solution to replace USP Levalbuterol Related Compound B RS with USP Albuterol Related Compound A RS. These reference standards represent the free base and sulfate salt chemical forms, respectively, of the same related compound. In addition, a revision to the wording of the Acceptance criteria is proposed to clarify that the limits associated with unspecified and total impurities are applicable to Any unspecified degradation product and Total degradation products, respectively. Changes to align the monograph with current USP style are also proposed.

It is anticipated that the proposed revisions will be published as an Interim Revision Announcement (IRA) in Pharmacopeial Forum 48(3) [May–Jun. 2022] pursuant to the Rules and Procedures. The comment period for this revision ends on July 31, 2022. In the absence of any adverse comments, the proposed IRA will become official on November 1, 2022.

Should you have any questions, please contact Nicholas Garito, Principal Scientist (