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 2
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 2 Expert Committee intends to revise the Orlistat monograph.
Comments with supporting data were received, indicating that the gradient table in Limit of Orlistat Related Compound E should be updated to clarify the steps with the same time at 38 min. In addition, the preparation of System suitability solution in Limits of Orlistat Related compound D and Orlistat Open Ring Amide needs to be revised to incorporate the recent formulation change to Orlistat Related Compound D Reference Standard. Other updates are also made to the monograph.
It is anticipated that the proposed revision will be published as an Interim Revision Announcement in Pharmacopeial Forum 47(4) [Jul–Aug 2021] pursuant to the Rules and Procedures. The comment period for this revision ends on Sep 30, 2021. In the absence of any adverse comments, the proposed IRA will become official on Jan 1, 2022.
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