Type of Posting: Notice of Intent to Revise
Posting Date: 10– April–2020
Targeted Official Date: 01-Dec-2021, USP-NF 2021 Issue 2,
Expert Committee: Biologics Monographs—Proteins (BIO2)
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 Monograph—Proteins (BIO2) Expert Committee intends to revise the Chymotrypsin and Chymotrypsin for Ophthalmic Solution monographs. It is anticipated that the proposed revisions will be published in Pharmacopeial Forum (PF) 46(3) [May-Jun. 2020] pursuant to section 7.05 of the Rules and Procedures.
USP plans to revise these monographs to delete the use of USP Crystallized Trypsin Reference Standard (RS). The monographs will be revised to specify the use of USP Trypsin Bovine RS.
USP will discontinue the USP Crystallized Trypsin RS. USP Trypsin Bovine RS is available for purchase at this time.
Should you have any questions, please contact Krishna Menon, Senior Scientific Liaison (firstname.lastname@example.org).