Packaging and storage—
Preserve in light-resistant, glass containers, in a refrigerator.
Labeling—
The label states: “
FATAL IF GIVEN INTRATHECALLY. FOR INTRAVENOUS USE ONLY.” Where labeled as containing more than 2 mg, it must also be labeled as a
Pharmacy Bulk Package (see
Injections 
1
). The labeling directs that the drug be dispensed only in containers enclosed in an overwrap labeled as directed below. When packaged in a
Pharmacy Bulk Package, it is exempt from the requirement under
Injections 1, that the closure be penetrated only one time after constitution with a suitable sterile transfer device or dispensing set, when it contains a suitable substance or mixture of substances to prevent the growth of microorganisms.
When dispensed, the container or syringe (holding the individual dose prepared for administration to the patient) must be enclosed in an overwrap bearing the statement “DO NOT REMOVE COVERING UNTIL MOMENT OF INJECTION. FATAL IF GIVEN INTRATHECALLY. FOR INTRAVENOUS USE ONLY.”
Identification—
Spray reagent—
Dissolve 2.0 g of ceric ammonium sulfate in 100 mL of water with heating and stirring, and slowly add 100 mL of phosphoric acid. Filter if necessary.
Procedure—
Transfer a volume of Injection, equivalent to 2 mg of vincristine sulfate, to a small centrifuge tube. For each mL of solution add 1 drop of ammonium hydroxide. Add 0.2 mL of dichloromethane. Place the cap on the tube, shake it vigorously for not less than 1 minute, and centrifuge for 1 minute. Carefully withdraw the dichloromethane layer, and transfer to a small stoppered vial. Proceed as directed for
Procedure in the test for
Identification under
Vincristine Sulfate for Injection, beginning with “Also prepare a 10-mg-per-mL solution of
USP Vincristine Sulfate RS.”
Related compounds—
Proceed as directed in the test for
Related compounds under
Vincristine Sulfate. Also inject into the chromatograph the same volume of a suitable dilution of any preservative present in the Injection, as identified in the labeling, and determine the retention time. The sum of the responses at retention times other than the retention time of vincristine and the retention times of preservatives does not exceed 6.0% of the total of all responses. The response due to
N-desformylvincristine, eluting at 1.4 ± 0.1 of the retention time of vincristine, is not more than 3.0% of all responses, and the response due to any other related substance is not more than 2.0% of all responses.
Assay—
Mobile phase, Standard preparation, System suitability preparation, and Chromatographic system—
Proceed as directed in the
Assay under
Vincristine Sulfate.
Assay preparation—
Dilute, if necessary, an accurately measured volume of Injection quantitatively with water to obtain a solution having a concentration of about 1 mg per mL, insert the stopper, and shake to mix.
Procedure—
Proceed as directed for
Procedure in the
Assay under
Vincristine Sulfate. Calculate the quantity, in mg, of vincristine sulfate (C
46H
56N
4O
10·H
2SO
4) in each mL of the Injection taken by the formula:
C(L / D)(rU / rS),
in which
C is the concentration, in mg per mL, of
USP Vincristine Sulfate RS corrected for loss in weight in the
Standard preparation; L is the labeled quantity, in mg per mL, of vincristine sulfate in Injection;
D is the concentration, in mg per mL, of vincristine sulfate in the
Assay preparation on the basis of the labeled quantity and the extent of dilution, if any; and
rU and
rS are the peak responses obtained from the
Assay preparation and the
Standard preparation, respectively.
