Type of Posting: Notice of Intent to Revise
Posting Date: 19-Feb-2021
Targeted Official Date: 01-May-2021, Revision Bulletin
Expert Committee: Small Molecules 1
In accordance with the Rules and Procedures of the Council of Experts, this is to provide notice that the USP Small Molecules 1 Expert Committee intends to revise the Pyrazinamide monograph.
Pyrazinamide monograph was revised and published in PF 45(6). Based on the comments received (https://www.uspnf.com/sites/default/files/usp_pdf/EN/USPNF/usp-nf-commentary/usp-nf-2021-issue-1-commentary.pdf), the Expert Committee approved the monograph for publication in USP-NF 2021, Issue 1,to be official on May 1, 2021. However, it was recently brought to USP’s attention that errors were inadvertently introduced in the acceptance criteria of Total impurities and Any unspecified impurity when the monograph was published in USP-NF 2021, Issue 1. The acceptance criteria should be NMT 0.2% instead of NMT 0.05% for Total impurities and NMT 0.05% instead of NMT 0.10% for Any unspecified impurity. The Expert Committee proposes to revise the monograph accordingly.
It is anticipated that the proposed revision will be published as a Revision Bulletin to include the correct acceptance criteria for Total Impurities and Any unspecified impurity limits. The Revision Bulletin is expected to be published on April 30 and become official on May 1, 2021.
Should you have any questions, please contact Praveen K. Pabba, Scientific Liaison (PKP@usp.org).