Colistin sulfate
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Colistine Sulphate
GMP CERTIFICATE, DMF OPEN PART
Specification: EP5
Assay:99%
Appearance: white powder
Colistine Sulphate
Other Name: Polymyxin E
CAS No.: 1264-72-8
Molecular Formula: 2C52H98N16O13.5H2SO4
Formula Weight: 2801.27
Test | Specification |
Characteristics | White or almost white powder |
Identification | Meets EP specification |
PH | 4.0 ~ 6.0 |
Loss on drying | ≤3.5% |
Optical rotation | -63° ~ -73° |
Sulphated ash | ≤1.0% |
Sulphate (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-I+E1-7MOA≥77.0% |
Related substances | Any impurity≤4.0% |
| Total impurity≤23.0% |
Potency(Moisture basis) | ------- |
Potency (Dried basis) | ≥19000IU/mg |
