| Customization: | Available |
|---|---|
| Powder: | Yes |
| Customized: | Non-Customized |
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| Items | Standards | Results |
| Appearance | Orange-red crystalline powder; No visible evidence of contamination by foreign matter. | Complies |
| Identification | By IR | Complies |
| By HPLC | Complies | |
| A white precipitate is formed | Complies | |
| Solubility | Soluble in water and methanol; slightly soluble in ethanol; practically insoluble in acetone. | Complies |
| pH | 4.0~5.5 | 5.2 |
| Water Content | ≤ 4.00% | 1.8% |
| Heavy Metals | ≤ 20ppm | Complies |
| Residue on Ignition | ≤ 0.10% | 0.07% |
| Residual Solvents | Acetone: ≤ 15000ppm | 1500ppm |
| Ethanol: ≤ 5000ppm | 3000ppm | |
| Ethyl Acetate: ≤ 5000ppm | ND | |
| Methanol: ≤ 1000ppm | 200ppm | |
| Methylene Chloride: ≤ 500ppm | ND | |
| Total Residual Solvents | ≤ 20000ppm | 4500ppm |
| Related Substances | Impurity A(Doxorubicinone): ≤1.00% | 0.20% |
| Impurity C(Doxorubicin): ≤1.00% | 0.20% | |
| Any other impurity: ≤0.50% | 0.20% | |
| Total Impurities: ≤2.00% | 0.80% | |
| Assay (on the anhydrous basis) | 97%~102% | 99.25% |
| Bacterial Endotoxins | Not more than 1.1 IU/mg | Conforms |
| Reference Standard | EP6.1 Standard | |
| Conclusion | The product complied to EP6.1 standard. | |
| Storage | Preserve in tight,light-resistant containers in a cool place | |
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