Vinblastine Sulfate for Injection
»Vinblastine Sulfate for Injection is Vinblastine Sulfate suitable for parenteral use.It contains not less than 90.0percent and not more than 110.0percent of the labeled amount of vinblastine sulfate (C46H58N4O9.H2SO4).
[Caution—Handle Vinblastine Sulfate for Injection with great care since it is a potent cytotoxic agent. ]
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ,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.”
Completeness of solution á641ñ— A10-mg portion dissolves in 10mLof Water for Injectionto yield a clear solution.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Bacterial endotoxins á85ñ— It contains not more than 10.0USP Endotoxin Units per mg of vinblastine sulfate.
Sterility á71ñ: meets the requirements.
Uniformity of dosage units á905ñ: meets the requirements.
Procedure for content uniformity—
Buffer solution— Dissolve 13.61g of sodium acetate in about 900mLof water in a 1000-mLvolumetric flask,adjust with glacial acetic acid to a pHof 5.0while stirring,dilute with water to volume,and mix.
Standard preparation— Dissolve an accurately weighed quantity of USP Vinblastine Sulfate RSin Buffer solution,and dilute quantitatively and stepwise with Buffer solutionto obtain a solution having a known concentration of about 40µg per mL.
Test preparation— Dissolve the contents of 1container of Vinblastine Sulfate for Injection in an accurately measured volume of Buffer solutionto obtain a solution having a concentration between 40µg per mLand 50µg per mL.
Procedure— Concomitantly determine the absorbances of the Test preparationand the Standard preparationin 1-cm cells at the wavelength of maximum absorbance at about 269nm versus the Buffer solutionas the blank.Calculate the quantity,in mg,of C46H58N4O9.H2SO4in the container taken by the formula:
0.001CV(AU/AS),
in which Cis the concentration,in µg per mL,of USP Vinblastine Sulfate RS(corrected for loss on drying)in the Standard preparation;Vis the volume,in mL,of Buffer solutiontaken for the Test preparation;and AUand ASare the absorbances of the Test preparationand the Standard preparation,respectively.
Related compounds— Proceed as directed in the test for Related compoundsunder 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 Identificationtests under Vinblastine Sulfate.It meets the requirements for Labelingunder Injections á1ñ.
Assay—
Mobile phase ,Standard preparation,System suitability preparation,and Chromatographic system—Prepare as directed in the Assayunder Vinblastine Sulfate.
Assay preparation— Pipet a suitable volume of water into each of 5containers of Vinblastine Sulfate for Injection to obtain a solution in each having a concentration of about 1mg per mL.Insert the stopper,shake to mix,and combine the solutions from the 5containers.Quantitatively dilute this solution with water to obtain a solution having a concentration of about 0.4mg per mL,and mix.
Procedure— Separately inject equal volumes (about 20µL)of the Standard preparationand the Assay preparationinto 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 Cis the concentration,in mg per mL,of USP Vinblastine Sulfate RS(corrected for loss in weight)in the Standard preparation;Vis the volume,in mL,of the Assay preparation;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 2024
Phone Number:1-301-816-8389