Vincristine Sulfate for Injection
» Vincristine Sulfate for Injection is a sterile mixture of Vincristine Sulfate with suitable diluents. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of vincristine sulfate (C46H56N4O10·H2SO4).
CautionHandle Vincristine Sulfate for Injection with great care since it is a potent cytotoxic agent.
Packaging and storage Preserve in Containers for Sterile Solids as described under Injections 1, 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.
USP Reference standards 11
USP Endotoxin RS.
USP Vinblastine Sulfate RS.
USP Vincristine Sulfate RS. [noteNo Loss on drying determination is needed for
USP Vinblastine Sulfate RS.]
Constituted solution At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
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 Dissolve a sufficient quantity in water to obtain a solution containing 25 mg per mL. Further dilute the solution to 10 mg per mL with methanol, and mix. Also prepare a 10-mg-per-mL solution of USP Vincristine Sulfate RS in a mixture of dichloromethane and methanol (3:1), and mix. Use a thin-layer chromatographic plate coated with a 0.25-mm layer of chromatographic silica gel mixture (see Chromatography 621). Develop it in a methanol prewash tank, and dry it, for maximum sensitivity, not more than 2 hours before use. Score it about 15 cm above the points of application. Apply 20 µL of each solution at points about 2.5 cm from the lower edge of the plate, and dry thoroughly (a current of cool air may be used to help dry the spots). Prepare the developing solvent system consisting of a mixture of fresh ether, methanol, and methylamine solution (2 in 5) (95:10:5) immediately prior to development. Place the plate in the nonequilibrated developing chamber that contains a paper liner around the back and sides and developing solvent to a depth of about 2 cm. Remove the plate when the solvent moves to the scored line (about 80 minutes), and discard the solvent system. Dry the plate in a fume hood at room temperature, heat on a metal plate on a steam bath for about 15 minutes, and spray the plate while still hot with Spray reagent. Continue heating the plate for 15 minutes to stabilize the spots: the RF value and the color of the principal spot obtained from the test specimen correspond to those obtained from the Reference Standard.
Bacterial endotoxins 85 It contains not more than 100.0 USP Endotoxin Units per mg of vincristine sulfate.
Uniformity of dosage units 905 It meets the requirements for solids.
procedure for content uniformity
Buffer solution Dissolve 6.3 g of ammonium formate in about 900 mL of water in a 1000-mL volumetric flask, adjust with formic acid to a pH of 5.0 while stirring, dilute with water to volume, and mix.
Standard preparation Dissolve an accurately weighed quantity of USP Vincristine Sulfate RS in Buffer solution, and dilute quantitatively and stepwise with Buffer solution to obtain a solution having a known concentration of about 40 µg per mL.
Test preparation Dissolve the contents of 1 container of Vincristine Sulfate for Injection in an accurately measured volume of Buffer solution to obtain a solution having a concentration between 40 and 50 µg per mL.
Procedure Concomitantly determine the absorbances of the Test preparation and the Standard preparation in 1-cm cells at the wavelength of maximum absorbance at about 262 nm versus the Buffer solution as the blank. Calculate the quantity, in mg, of C46H56N4O10·H2SO4 in the container taken by the formula:
0.001CV(AU / AS)in which C is the concentration, in µg per mL, of USP Vincristine Sulfate RS (corrected for loss in weight) in the Standard preparation,V is the volume, in mL, to which the contents of the container are diluted, and AU and AS are the absorbances of the Test preparation and the Standard preparation, respectively.
Related compounds Proceed as directed in the test for Related compounds under Vincristine Sulfate. The total of the responses due to related substances does not exceed 5.0%, and no single related substance response exceeds 2.0%.
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 Prepare as directed in the Assay under Vincristine Sulfate.
Assay preparation Pipet a suitable volume of water into a container of Vincristine Sulfate for Injection to obtain a solution having a concentration of about 1 mg of vincristine sulfate 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 the portion of Vincristine Sulfate for Injection taken by the formula:
10C(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; and rU and rS are the peak responses for vincristine sulfate obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information Please check for your question in the FAQs before contacting USP.Chromatographic Column
USP32NF27 Page 3862Pharmacopeial Forum: Volume No. 32(5) Page 1470
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.