Vincristine Sulfate Injection
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 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 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.
In addition, "+ 0.1" is removed from the relative retention time of N-desformylvincristine in Table 2 under Organic Impurities. This change is consistent with the statement in <621> Chromatography that no acceptance criteria are applied to relative retention times.
The Vincristine Sulfate Injection Revision Bulletin supersedes the currently official monograph. The Revision Bulletin will be incorporated in USP 35–NF 30.
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