(mye'' toe mye' sin).
6-Amino-1,1a,2,8,8a,8b-hexahydro-8-(hydroxymethyl)-8a-methoxy-5-methylazirino[2¢,3¢: 3,4]-pyrrolo[1,2-a]indole-4,7-dione carbamate (ester).
Mitomycin C [50-07-7].
» Mitomycin has a potency of not less than 970 µg of C15H18N4O5 per mg.
Packaging and storage Preserve in tight, light-resistant containers. Store at 25, excursion permitted between 15 and 30.
Labeling Where it is intended for use in preparing injectable dosage forms, the label states that it is sterile or must be subjected to further processing during the preparation of injectable dosage forms.
USP Reference standards 11
A: Infrared Absorption 197MDo not dry specimens.
B: Ultraviolet Absorption 197U
Solution: 5 µg per mL.
Absorptivity at 357 nm is not less than 95.0% and not more than 105.0% of USP Mitomycin RS, calculated on the anhydrous basis.
Crystallinity 695: meets the requirements.
pH 791: between 6.0 and 7.5, in an aqueous suspension containing 5 mg per mL.
Water, Method I 921: not more than 2.5%.
Other requirements Where the label states that Mitomycin is sterile, it meets the requirements of the tests for Sterility and Bacterial endotoxins under Mitomycin for Injection. Where the label states that Mitomycin must be subjected to further processing during the preparation of injectable dosage forms, it meets the requirements of the test for Bacterial endotoxins under Mitomycin for Injection.
Mobile phase Dissolve 1.54 g of ammonium acetate in 250 mL of methanol, add 5.0 mL of 0.83 N acetic acid and water to make 1000 mL, and mix. Pass through a filter having a 0.5-µm or finer porosity, and degas. Make adjustments if necessary (see System Suitability under Chromatography 621).
Standard preparation Quantitatively dissolve an accurately weighed quantity of USP Mitomycin RS in N,N-dimethylacetamide to obtain a solution having a known concentration of about 0.5 mg per mL.
Resolution solution Dissolve suitable quantities of USP Mitomycin RS and 3-ethoxy-4-hydroxybenzaldehyde in N,N-dimethylacetamide to obtain a solution containing about 0.5 mg and 7.5 mg per mL, respectively.
Assay preparation Transfer about 25 mg of Mitomycin, accurately weighed, to a 50-mL volumetric flask, add N,N-dimethylacetamide to volume, and mix to dissolve.
Chromatographic system (see Chromatography 621) The liquid chromatograph is equipped with a 365-nm detector and a 4-mm × 30-cm column that contains packing L11. The flow rate is about 2 mL per minute. Chromatograph the Resolution solution, and record the peak responses as directed under Procedure: the resolution, R, between the mitomycin and the 3-ethoxy-4-hydroxybenzaldehyde peaks is not less than 1.8. The relative retention times are about 1.0 for mitomycin and 1.4 for 3-ethoxy-4-hydroxybenzaldehyde. Chromatograph the Standard preparation, and record the peak responses as directed for Procedure: the tailing factor for the mitomycin peak is not more than 1.3; and the relative standard deviation for replicate injections is not more than 2.0%.
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 µg, of C15H18N4O5 in each mg of the Mitomycin taken by the formula:
50(CP/W)(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 the USP Mitomycin RS; W is the weight, in mg, of Mitomycin taken to prepare the Assay preparation; and rU and rS are the peak areas obtained from the Assay preparation and the Standard preparation, respectively.
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USP35NF30 Page 3936Pharmacopeial Forum: Volume No. 29(4) Page 1052