Customization: | Available |
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Function: | Pharmaceutical Medicine |
Certification: | GMP, FDA, ISO |
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ITEMS | STANDARD | RESULTS |
CHARACTERISTICS | Orange-red crystalline powder, hygroscopic | Conforms |
SOLUBILITY | Freely soluble in water and in methanol, slightly soluble in alcohol, practically insoluble in acetone |
Conforms |
IDENTIFICATION | Infrared absorption spectrophotometry, Comparison: daunorubicin hydrochloride CRS. | Conforms |
The retention time of the Daunorubicin peak in the chromatogram of the test preparation corresponds to that in the chromatogram of the standard preparation. | Conforms | |
Crystallinity | Meets the requirements. | Conforms |
pH | 4.0 to 6.5 | 5.7 |
WATER CONTENT | NMT 3.0% | 1.71% |
RELATIVE SUBSTANCE | Any max single impurity:≤1.5% | 0.52% |
Total impurities:≤ 3.0% | 0.96% | |
SOLVENT RESIDUES (By GC) |
Methanol:≤0.2% | Not Detected |
Acetone:≤0.5% | 0.16% | |
Butanol:≤1.0% | 0.31% | |
ASSAY | 84.2% ~ 103.0% (C27H29NO10) | 97.3% |
Conclusion:The results conform to the standard of USP32. |