Type of Posting: Revision Bulletin
Posting Date: 30–Jun–2011
Official Date: 01–Jul–2011
Expert Committee: Monographs—Small Molecules 3
Reason for Revision: Compliance
In accordance with the Rules and Procedures of the 2010–2015 Council of Experts, the Monographs—Small Molecules 3 Expert Committee has revised the Ivermectin Paste monograph. The purpose of this revision is to accommodate the sponsor’s FDA-approved specifications:
- Widen the Assay acceptance criteria from 95.0%–110.0% to 90.0%–110.0%.
- Increase the limit of any peak with a relative retention time of 1.3–1.5 under Organic Impurities from NMT 2.7% to NMT 3.0%. In addition, the calculation has been clarified to specify that the principal peak from the Standard solution is used for quantification of impurities.
The Ivermectin Paste Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in USP 35–NF 30.
Should you have any questions, please contact Morgan Puderbaugh (301-998-6833 or mxp@usp.org).