Type of Posting: Notice of Intent to Revise
Posting Date: 30-Apr-2021
Targeted Official Date: TBD
Expert Committee: Complex Excipients
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the Complex Excipients Expert Committee intends to revise the USP Copovidone monograph. Comments were received related to issues in performing the test for vinyl acetate impurity, which is a part of the new test for Limit of Monomers (1-Vinyl-2-Pyrrolidone and Vinyl acetate) in the Copovidone monograph revision targeted to become official on May 1, 2021.
The Copovidone monograph is a part of the work plan of Pharmacopeial Discussion Group (PDG). PDG is aware of the issue regarding the vinyl acetate impurity test. Experts from the PDG will perform further investigation and revise the method. As soon as PDG revises the method, USP will publish a revision to the monograph. If you have a method suitable for testing the vinyl acetate impurity, please contact USP, European Pharmacopoeia, or Japanese Pharmacopeia with your supporting data.
Should you have any questions, please contact Jenny Liu, Ph.D., Principal Scientist (firstname.lastname@example.org).