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| Doxorubicin HCl |
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| Chemical raw material |
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| 25316-40-9 |
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| Chemical raw material |
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Test Items Specifications
Appearance Orange-red crystalline powder
No visible evidence of contamination by foreign material
Identification The major peak of the Assay Preparation has a retention time that corresponds to the retention time of the reference standard
PH 4.0-5.5
Water Content Not more than 4.0%
Assay 98.0% to 102.0% (calculated on the anhydrous, solvent-free basis)
Chromatographic Purity Not more than 2.0%
Adriamycinone Not more than 1.0%
Acetone Not more than 5000ppm
Acetone& Alcohol Not more than25000ppm
Organic Volatile Impurities
Methylene Chloride Not more than 100ppm
Residual Methanol Not more than 1000ppm
Bacterial Endotoxins Not more than 2.2EU/mg
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