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 Vinblastine Sulfate monograph.
To address the USP Vincristine Sulfate RS supply issue, a new reference standard, USP Vincristine Sulfate (Assay) RS, which is a lyophilized vincristine sulfate in single-use vials containing lactose, is added to the monograph. The System suitability solution in the Assay is revised to allow the use of both the current reference standard, USP Vincristine Sulfate RS, and a new reference standard, USP Vincristine Sulfate (Assay) RS.
The Vinblastine Sulfate 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 Feiwen Mao (301-816-8320 or fm@usp.org).