Item | Specification |
Appearance | Blue-violet, crystalline powder |
Identification | IR: The IR spectrum of the sample corresponds to the spectrum of reference standard |
HPLC: The retention time of the major peak of the sample solution corresponds to that of the standard solution, as obtained in the Assay | |
pH | 6.0~7.5 |
Water | Not more than 2.5% |
Crystallinity | Should conforms |
Related Substances | |
Albomitomycin C (EP Impurity D) | Not more than 0.5% |
Mitomycin B (EP Impurity C) | Not more than 0.5% |
Cinnamamide (EP Impurity A) | Not more than 0.5% |
Mitomycin A (EP Impurity B) | Not more than 0.5% |
Any Individual Unspecified Impurity | Not more than 0.5% |
Total Impurities | Not more than 2.0% |
Residual Solvents | |
Methanol | Not more than 3000 ppm |
Methylene Chloride | Not more than 600 ppm |
Ethyl Acetate | Not more than 5000 ppm |
Bacterial Endotoxins | Not more than 10 EU/mg |
Assay | Not less than 970 mg/g of Mitomycin |