Type of Posting: Notice of Intent to Revise
Posting Date: 31–Mar–2017
Targeted Official Date: 01–May–2017, Revision Bulletin (Postponement)
Expert Committee: Chemical Medicines Monographs 3
In accordance with section 7.05(c) of the Rules and Procedures of the Council of Experts, this is to provide notice that the Chemical Medicines Monographs 3 Expert Committee intends to indefinitely postpone the test for Organic impurities in the Selamectin monograph, which is currently scheduled to become official on May 1, 2017 in USP 40-NF 35 .
USP has received comments concerning the system suitability resolution requirement in the test for Organic impurities. Additional information will be required in order to resolve these concerns. Interested parties are invited to contact USP for additional information on this topic and to get involved in the revision process. If data cannot be obtained to revise the resolution requirement, the Expert Committee will consider removing this criterion from the test for Organic impurities. The process for and timing of any future revision to include the test for Organic impurities will be determined following additional consideration by the Expert Committee and USP staff.
The postponement of the test for Organic impurities in the Selamectin monograph will be published as a Revision Bulletin on April 28, 2017 and will become official on May 1, 2017. The Selamectin Revision Bulletin Postponement will supersede the monograph becoming official in USP 40–NF 35.
Should you have any questions, please contact Morgan Puderbaugh, Senior Scientific Liaison (301-998-6833 or firstname.lastname@example.org).