Type of Posting: Notice of Intent to Revise
Posting Date: 29-Dec-2023
Targeted Official Date: 01-Sep-2024; Interim Revision Announcement
Expert Committee: Small Molecules 4
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Small Molecules 4 Expert Committee intends to revise the Gadopentetate Dimeglumine Injection monograph.
It was brought to USP’s attention that there are errors in the test for the Limit of Pentetic Acid. Based on the sponsor’s supporting documents, the Expert Committee proposes to revise the Diluent, Sample solution, calculations, and acceptance criteria in the test for the Limit of Pentetic Acid.
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 50(2) [Mar.–Apr. 2024] pursuant to the Rules and Procedures of the Council of Experts. If published as anticipated, the comment period for this revision would end on May 31, 2024. In the absence of any adverse comments, the proposed IRA would become official on September 1, 2024.
Should you have any questions, please contact Gerald Hsu, Principal Scientist (gdh@usp.org).