Vinblastine Sulfate for Injection
» Vinblastine Sulfate for Injection is Vinblastine Sulfate suitable for parenteral use. It contains not less than 90.0 percent and not more than 110.0 percent of the labeled amount of vinblastine sulfate (C46H58N4O9·H2SO4).
CautionHandle Vinblastine 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.
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 Vincristine Sulfate RS.]
Completeness of solution 641 A 10-mg portion dissolves in 10 mL of Water for Injection to yield a clear solution.
Constituted solution At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Bacterial endotoxins 85 It contains not more than 10.0 USP Endotoxin Units per mg of vinblastine sulfate.
Sterility 71: meets the requirements.
Uniformity of dosage units 905: meets the requirements.
procedure for content uniformity
Buffer solution Dissolve 13.61 g of sodium acetate in about 900 mL of water in a 1000-mL volumetric flask, adjust with glacial acetic 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 Vinblastine 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 Vinblastine Sulfate for Injection in an accurately measured volume of Buffer solution to obtain a solution having a concentration between 40 µg per mL 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 269 nm versus the Buffer solution as the blank. Calculate the quantity, in mg, of C46H58N4O9·H2SO4 in the container taken by the formula:
0.001CV(AU / AS)in which C is the concentration, in µg per mL, of USP Vinblastine Sulfate RS (corrected for loss on drying) in the Standard preparation; V is the volume, in mL, of Buffer solution taken for the Test preparation; 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 Vinblastine 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 responds to the Identification tests under Vinblastine Sulfate. It meets the requirements for Labeling under Injections 1.
Mobile phase , Standard preparation, System suitability preparation, and Chromatographic systemPrepare as directed in the Assay under Vinblastine Sulfate.
Assay preparation Pipet a suitable volume of water into each of 5 containers of Vinblastine Sulfate for Injection to obtain a solution in each having a concentration of about 1 mg per mL. Insert the stopper, shake to mix, and combine the solutions from the 5 containers. Quantitatively dilute this solution with water to obtain a solution having a concentration of about 0.4 mg per mL, and mix.
Procedure Separately inject equal volumes (about 20 µL) of the Standard preparation and the Assay preparation into the chromatograph, record the chromatograms, and measure the responses for the major peaks. Calculate the quantity, in mg, of vinablastine sulfate (C46H58N4O9·H2SO4) in each container of Vinblastine Sulfate for Injection taken by the formula:
0.2CV(rU / rS)in which C is the concentration, in mg per mL, of USP Vinblastine Sulfate RS (corrected for loss in weight) in the Standard preparation; V is the volume, in mL, of the Assay preparation; and rU and rS are the peak responses 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 3860Pharmacopeial Forum: Volume No. 34(4) Page 995
Chromatographic columns text is not derived from, and not part of, USP 32 or NF 27.