Type of Posting: Notice of Intent to Revise
Posting Date: 30–Apr–2020; updated 14–May–2020*
Targeted Official Date: March 1, 2021, Interim Revision Announcement
Expert Committee: Biologics Monographs 1 – Peptides and Insulins
In accordance with section 7.04(c) of the 2015–2020 Rules and Procedures of the Council of Experts, this is to provide notice that the Biologics Monographs 1 – Peptides & Insulins intends to revise the Desmopressin Acetate monograph.
The Expert Committee is proposing a revision to the Desmopressin Acetate monograph to replace the use of the USP Oxytocin Reference Standard (RS) in the preparation of the system suitability solution in the Assay test with the USP Oxytocin Identification RS. The use of the USP Oxytocin Identification RS will provide specific testing advantages as it is formulated to support the preparation of system suitability solution.
It is anticipated that the proposed revision will be published as a proposed Interim Revision Announcement (IRA) in Pharmacopeial Forum 46(5) [Sep.–Oct. 2020] pursuant to section 7.02 of the Rules and Procedures of the Council of Experts. The comment period for this revision ends on November 30, 2020. In the absence of any adverse comments, the proposed IRA will become official on March 1, 2021.
Should you have any questions, please contact Elena Curti, Associate Science and Standards Liaison (301-998-6803 or firstname.lastname@example.org).
*This Notice was updated on May 14, 2020 to correct a typographical error.