| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Non-Customized |
|
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| Items | Specifications | Result |
| Appearance | Blue-violet crystals or crystalline powder | Blue-violet crystalline powder |
| Identification | ||
| A: Infrared absorption spectrum | The infrared absorption spectrum is concordant with that of the reference standard | Conform |
| B: HPLC | The retention time of the major peak of the sample solution corresponds to that of the standard solution, s obtained in the assay. | Conform |
| PH | 6.0~7.5 | 6.2 |
| Water | ≤2.5% | 0.1% |
| Crystallinity | Should conform to the criteria | Conform |
| Related substances | Impurity A (Cinnamamide) ≤0.5% Impurity B (Mitomycin A) ≤0.5% Impurity C (Mitomycin B) ≤0.5% Impurity D (Albomitomycin) ≤0.5% Any other impurity ≤0.5% Total impurities ≤2.0% |
ND ND ND <0.1% <0.1% 0.1% |
| Bacterial endotoxins | Less than 10EU/mg | <10EU/mg |
| Microbial contamination | TAMC≤103cfu/g TYMC≤102cfu/g |
<10cfu/g <10cfu/g |
| Assay | ≥970μg/mg | 987μg/mg |
| Residual solvents | Methano l≤3000ppm Ethy l ether≤5000ppm Ethy l acetate≤5000ppm |
376ppm 40ppm ND |
| Conclusion | Conform to the specification of USP42. | |
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