Type of Posting: Notice of Intent to Revise
Posting Date: 17–Apr–2015; updated 26–Jun–2015*
Targeted Official Date: 01–Aug–2015, Revision Bulletin
Expert Committee: Monographs—Small Molecules 1
In accordance with section 7.05 (c) of the Rules and Procedures of the Council of Experts, this is to provide notice that the USP Monographs—Small Molecules 1 Expert Committee intends to revise the Piperacillin and Tazobactam for Injection monograph as follows:
- The limits in the test for Organic Impurities Procedure 3 will be revised to reflect FDA-approved acceptance criteria.
- The concentrations of the standards in the Stock standard solution in Organic Impurities Procedure 4 will be corrected.
It is anticipated that the proposed revision will be published as a Revision Bulletin on July 31, 2015 and become official on August 1, 2015 pursuant to section 7.02 of the Rules and Procedures.
Should you have any questions, please contact Ahalya Wise, Scientific Liaison to the Monographs —Small Molecules 1 (301–816–8161 or aww@usp.org).
*Notice was updated on June 26, 2015 to include specific targeted official date and publication.