Mitomycin for Injection
»Mitomycin for Injection contains not less than 90.0percent and not more than 120.0percent of the labeled amount of mitomycin (C15H18N4O5).
Packaging and storage— Preserve in Containers for Sterile Solidsas described under Injections á1ñ,protected from light.Store at 25,excursion permitted between 15and 30.
Constituted solution— At the time of use,it meets the requirements for Constituted Solutionsunder Injections á1ñ.
Identification— Dissolve a quantity in water,and dilute with water to obtain a solution having a concentration of about 1mg of mitomycin per mL.Apply 2µLof this solution and 2µLof a Standard solution of USP Mitomycin RS,similarly prepared to a suitable thin-layer chromatographic plate (see Chromatography á621ñ)coated with a 0.25-mm layer of chromatographic silica gel mixture.Allow the spots to dry,and develop the chromatograms in a solvent system consisting of a mixture of butyl alcohol,glacial acetic acid,and water (4:2:1).Remove the plate from the developing chamber,mark the solvent front,and allow the solvent to evaporate.Spray the plate with a 1in 100solution of ninhydrin in alcohol.Heat the plate in an oven at 110for 15minutes.Mitomycin appears as a pink spot:the RFvalue of the principal spot obtained from the solution under test corresponds to that obtained from the Standard solution.
Bacterial endotoxins á85ñ— It contains not more than 10.0USP Endotoxin Units per mg of mitomycin.
Sterility á71ñ— It meets the requirements when tested as directed for Membrane Filtrationunder Test for Sterility of the Product to be Examined.
pHá791ñ: in the solution constituted as directed in the labeling,between 6.0and 8.0where it contains mannitol and between 5.5and 8.5where it contains hydroxypropyl betadex.
Water,Method Ia á921ñ: not more than 5.0%,the Test preparationbeing prepared as directed for a hygroscopic specimen,using the pooled contents of 5containers.
Other requirements— It meets the requirements under Injections á1ñand Uniformity of Dosage Units á905ñ.
Assay—
Mobile phase,Standard preparation,Resolution solution,and Chromatographic system— Prepare as directed in the Assayunder Mitomycin.
Assay preparation— Add an accurately measured volume of N,N-dimethylacetamide to 1container of Mitomycin for Injection to obtain a solution having a concentration of about 0.5mg of mitomycin per mL.
Procedure— Separately inject equal volumes (about 10µL)of the Standard preparationand the Assay preparationinto the chromatograph,record the chromatograms,and measure the areas for the major peaks.Calculate the quantity,in mg,of mitomycin (C15H18N4O5)in the container of Mitomycin for Injection taken by the formula:
(CP/1000)(L/D)(rU/rS),
in which Cis the concentration,in mg per mL,of USP Mitomycin RSin the Standard preparation;Pis the stated potency,in µg per mg,of USP Mitomycin RS;Lis the labeled quantity,in mg,of mitomycin in the container;Dis the concentration,in mg per mL,of mitomycin in the Assay preparation,on the basis of the labeled quantity and the extent of dilution;and rUand rSare the peak areas obtained from the Assay preparationand the Standard preparation,respectively.
Auxiliary Information— Staff Liaison:William W.Wright,Ph.D.,Scientific Fellow
Expert Committee:(PA7)Pharmaceutical Analysis 7
USP28–NF23Page 1302
Pharmacopeial Forum:Volume No.29(4)Page 1053
Phone Number:1-301-816-8335