Type of Posting: Notice of Intent to Revise
Posting Date: 28–May–2021
Targeted Official Date: 01–Jan–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 Ipratropium Bromide Inhalation Solution monograph.
Comments were received identifying inappropriate acceptance criteria for the Relative standard deviation requirement in the Assay. The current acceptance criteria for Relative standard deviation described a minimum resolution, rather than a maximum precision, requirement. The Expert Committee proposes to revise the Relative standard deviation acceptance criteria to reflect a maximum precision requirement that is based on supporting data.
It is anticipated that the proposed revision will be published as a proposed Interim Revision Announcement (IRA) in Pharmacopeial Forum 47(4) [Jul.–Aug. 2021] pursuant to the Rules and Procedures. The comment period for this revision ends on September 30, 2021. In the absence of any adverse comments, the proposed IRA will become official on January 1, 2022.
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