Type of Posting: Notice of Intent to Revise
Posting Date: 01–Oct–2021
Targeted Official Date: 01-Aug-2023, USP-NF 2023 Issue 2
Expert Committee: Biologics Monographs 1 - Peptides & Oligonucleotides (BIO1)
In accordance with the Rules and Procedures of the 2020–2025 Council of Experts (Rules and Procedures), this is to provide notice that the Biologics Monographs 1–Peptides & Oligonucleotides (BIO1) Expert Committee intends to revise the Glucagon monograph.
The Expert Committee proposes to revise the Glucagon monograph to include methods suitable for testing glucagon produced by either synthetic or microbial processes using recombinant DNA (rDNA) technology. Revisions include updating the acceptance criteria of the assay and impurities test for synthetic and rDNA origin, adding a process-related impurities test for synthetic origin, specifying peptide mapping is for rDNA origin, and adding mass spectral analysis for synthetic origin.
It is anticipated that the proposed revision will be published as an In-Process Revision in Pharmacopeial Forum 48(2) [Mar.–Apr. 2022] pursuant to the Rules and Procedures.
Should you have any questions, please contact Julie Zhang, Team Lead-Sr. Scientist II (Julie.firstname.lastname@example.org).