Epirubicin hydrochloride CAS No 56390-09-1
| Items of analusis |
Speacification |
Result |
| Appearance |
Orange-red powder |
conforms |
| Solubility |
Soluble in water and methanol,slightly soluble in anhydrous ethanol,practically insoluble in acetone. |
conforms |
| Identification |
A:IR spectrum should comply with that of its RS. |
conforms |
| B:The retention time of principal peak should comply with its RS. |
conforms |
| C:Showing the white precipitate reaction. |
conforms |
| pH value |
4.0-5.5 |
4.8 |
| Related substance |
Impurity A: not more than 1.0% |
0.074% |
| Impurity C: not more than 1.0% |
0.14% |
| Other individual impurity(B/D/E/F/G):not more than 0.5% |
Undetected |
| Unknown impurity:not more than 0.1% |
0.059% |
| Total impurities:not more than 2.0% |
0.27% |
| Residual solvents |
Acetone:NMT 1.5% |
Undetected |
| Ethanol:NMT 1.0% |
0.47% |
| Dichloromethane:NMT 0.06% |
Undetected |
| Mtthanol:NMT 0.3% |
Undetected |
| Water |
Not more than 4.0% |
1.8% |
| Bacterial endotoxin |
Less than 1.1EU/mg |
<1.1EU/mg |
| Conclusion |
Conforms to the requirements of EP. |
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