Type of Posting: Notice of Intent to Revise
Posting Date: 25-Apr-2025
Targeted Official Date: 01-Jan-2026; Interim Revision Announcement
Expert Committee: Small Molecules 3
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 3 Expert Committee intends to revise the Dapagliflozin Propanediol monograph.
The purpose of the revision is to clarify that the relative standard deviation system suitability requirement in the Content of Propanediol test applies to the ratio of the peak areas of the analyte and the internal standard. Additionally, it is proposed to incorporate the two-table format for Organic Impurities, to present the relative retention times in Table 3 and acceptance criteria in Table 4.
It is anticipated that the proposed revision will be published as an Interim Revision Announcement in Pharmacopeial Forum 51(4) [Jul. 2025 – Aug. 2025] pursuant to the Rules and Procedures. The comment period for this revision ends on September 30, 2025. In the absence of any adverse comments, the proposed IRA will become official on January 1, 2026.
Should you have any questions, please contact Robyn Fales, Senior Scientist I (rnp@usp.org).