Specifications
Test | Specification |
Characteristics | White or alm white powder |
Identification | Meets EP specification |
PH | 4.0-6.0 |
Loss on drying | ≤3.5% |
Optical | -63°˜-73° |
Sulfateed ash | ≤1.0% |
Sulfate(dried basis) | 16.0%-18.0% |
Content (Dry basis HPLC) | Colistin E1-I≤10% |
Colistin E1-7MOA≤10% | |
Colistin E3≤10% | |
E1+E2+E3+E1-7MOA≥77.0% | |
Related substance | Any impurity≤4.0% |
Total impurity | ≤23.0% |
Potency(Moisture basis) | |
Potency(Dried basis) | ≥19000IU/mg |