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Mitomycin for Injection
» Mitomycin for Injection contains not less than 90.0 percent and not more than 120.0 percent of the labeled amount of mitomycin (C15H18N4O5).
Packaging and storage— Preserve in Containers for Sterile Solids as described under Injections 1, protected from light. Store at 25, excursion permitted between 15 and 30.
Constituted solution— At the time of use, it meets the requirements for Constituted Solutions under Injections 1.
Identification— Dissolve a quantity in water, and dilute with water to obtain a solution having a concentration of about 1 mg of mitomycin per mL. Apply 2 µL of this solution and 2 µL of a Standard solution of USP Mitomycin RS, similarly prepared to a suitable thin-layer chromatographic plate (see Chromatography 621) 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 1 in 100 solution of ninhydrin in alcohol. Heat the plate in an oven at 110 for 15 minutes. Mitomycin appears as a pink spot: the RF value of the principal spot obtained from the solution under test corresponds to that obtained from the Standard solution.
Bacterial endotoxins 85— It contains not more than 10.0 USP Endotoxin Units per mg of mitomycin.
Sterility 71— It meets the requirements when tested as directed for Membrane Filtration under Test for Sterility of the Product to be Examined.
pH 791: in the solution constituted as directed in the labeling, between 6.0 and 8.0 where it contains mannitol and between 5.5 and 8.5 where it contains hydroxypropyl betadex.
Water, Method Ia 921: not more than 5.0%, the Test preparation being prepared as directed for a hygroscopic specimen, using the pooled contents of 5 containers.
Residual solvents 467: meets the requirements.
(Official January 1, 2007)
Other requirements— It meets the requirements under Injections 1 and Uniformity of Dosage Units 905.
Assay—
Mobile phase, Standard preparation, Resolution solution, and Chromatographic system— Prepare as directed in the Assay under Mitomycin.
Assay preparation— Add an accurately measured volume of N,N-dimethylacetamide to 1 container of Mitomycin for Injection to obtain a solution having a concentration of about 0.5 mg of mitomycin per mL.
Procedure— Separately inject equal volumes (about 10 µL) of the Standard preparation and the Assay preparation into 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 C is the concentration, in mg per mL, of USP Mitomycin RS in the Standard preparation; P is the stated potency, in µg per mg, of USP Mitomycin RS; L is the labeled quantity, in mg, of mitomycin in the container; D is 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 rU and rS are the peak areas obtained from the Assay preparation and the Standard preparation, respectively.
Auxiliary Information— Staff Liaison : Brian D. Gilbert, Ph.D., Scientist
Expert Committee : (MDANT05) Monograph Development-Antibiotics
USP29–NF24 Page 1445
Pharmacopeial Forum : Volume No. 29(4) Page 1053
Phone Number : 1-301-816-8223