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Vincristine Sulfate Injection
» Vincristine Sulfate Injection is a sterile solution of Vincristine Sulfate in Water for Injection. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of vincristine sulfate (C46H56N4O10·H2SO4).
Caution—Handle Vincristine Sulfate Injection with great care since it is a potent cytotoxic agent.
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.”
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.”
Bacterial endotoxins 85 It contains not more than 62.5 USP Endotoxin Units per mg of vincristine sulfate.
pH 791: between 3.5 and 5.5.
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.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements for Sterility Tests 71 and for Labeling under Injections 1.
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 (C46H56N4O10·H2SO4) 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.
Auxiliary Information— Staff Liaison : Feiwen Mao, M.S., Senior Scientific Associate
Expert Committee : (MDOOD05) Monograph Development-Ophthalmics Oncologics and Dermatologicals
USP29–NF24 Page 2255
Phone Number : 1-301-816-8320