Vincristine Sulfate Injection
»Vincristine Sulfate Injection is a sterile solution of Vincristine Sulfate in Water for Injection.It contains not less than 90.0percent and not more than 110.0percent 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 2mg,it must also be labeled as a Pharmacy Bulk Package(see Injections á1ñ).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 á1ñ,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 2.0g of ceric ammonium sulfate in 100mLof water with heating and stirring,and slowly add 100mLof phosphoric acid.Filter if necessary.
Procedure— Transfer a volume of Injection,equivalent to 2mg of vincristine sulfate,to a small centrifuge tube.For each mLof solution add 1drop of ammonium hydroxide.Add 0.2mLof dichloromethane.Place the cap on the tube,shake it vigorously for not less than 1minute,and centrifuge for 1minute.Carefully withdraw the dichloromethane layer,and transfer to a small stoppered vial.Proceed as directed for Procedurein the test for Identificationunder Vincristine Sulfate for Injection,beginning with “Also prepare a 10-mg-per-mLsolution of USP Vincristine Sulfate RS.”
Bacterial endotoxins á85ñ— It contains not more than 62.5USP Endotoxin Units per mg of vincristine sulfate.
pHá791ñ: between 3.5and 5.5.
Related compounds— Proceed as directed in the test for Related compoundsunder 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 toN-desformylvincristine,eluting at 1.4±0.1of 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.
Other requirements— It meets the requirements for Sterility Tests á71ñand for Labelingunder Injections á1ñ.
Assay—
Mobile phase,Standard preparation,System suitability preparation,and Chromatographic system— Proceed as directed in the Assayunder 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 1mg per mL,insert the stopper,and shake to mix.
Procedure— Proceed as directed for Procedurein the Assayunder Vincristine Sulfate.Calculate the quantity,in mg,of vincristine sulfate (C46H56N4O10·H2SO4)in each mLof the Injection taken by the formula:
C(L/D)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Vincristine Sulfate RScorrected for loss in weight in the Standard preparation;Lis the labeled quantity,in mg per mL,of vincristine sulfate in Injection;Dis the concentration,in mg per mL,of vincristine sulfate in the Assay preparationon the basis of the labeled quantity and the extent of dilution,if any;and rUand rSare the peak responses obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:Lawrence Evans,III,Ph.D.,Scientist
Expert Committee:(PA6)Pharmaceutical Analysis 6
USP28–NF23Page 2026
Phone Number:1-301-816-8389