Vincristine Sulfate for Injection

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 Vincristine Sulfate for Injection 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 inclusion of the new Reference Standard necessitates the following changes:

  • The Standard solution and System suitability solution in the Assay are 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 concentrations of the Standard solution and the Sample solution are changed from 1.0 mg/mL to 1.2 mg/mL, to be consistent with the amount of material in the single-use vials.
  • The Standard solution in the Uniformity of Dosage Units is also 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 concentration of the Standard solution is slightly modified to be consistent with the concentration of the Sample solution.
  • The Identification-A test is revised to specify that the new reference standard, USP Vincristine Sulfate (Assay) RS, could also be used for the preparation of the Standard solution.

The Vincristine Sulfate for Injection 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).