| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Non-Customized |
|
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| Items | Requirements | Result |
| Appearance | White to off-white amorphous powder. | Off-white amorphous powder |
| Identification | IR | Conforms |
| Reaction of sulfate | Conforms | |
| Copper | ≤0.1% | 0.0% |
| PH | 4.5~6.0 | 5.0 |
| Loss on Drying | ≤6.0% | 2.3% |
| Bacterial Endotoxins | ≤10EU/U | <0.5EU/U |
| Potency | 1.5~2.0U/mg | 1.6U/mg |
| Content of Bleomycins |
Bleomycin A2: 55~70% | 67% |
| Bleomycin B2: 25~32% | 29% | |
| Bleomycin A2+B2≥90% | 97% | |
| Bleomycin A4≤1.0% | <0.05% | |
| Residual Solvents | Acetone≤20000ppm | 6121ppm |
| Ethanol≤5000ppm | 339ppm | |
| Bioburden | Total Aerobic Count≤100 cfu/gm | 24cfu/gm |
| Total Mold and Yeast≤50 cfu/gm | 19cfu/gm | |
| Conclusion | The results conform to USP specification. | |
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