CAS number： 1264-72-8
Molecular formula： C52H98N16O13
molecular weight： 1155.4339
Chemical structure：
| Product | Colistin Sulfate | |||
| Shelf Life | 2 years | |||
| Inspection Standard | EP 7.0 | |||
| Test Items | Specifications | Results | ||
| Appearance | White or almost white, hygroscopic powder | Complies | ||
| Specific rotation | -63º~ -73º | -72° | ||
| Identification | HPLC retention time | Correspons to that of the standard | Complies | |
| Reaction of sulfates | Positive | Complies | ||
| pH | 4.0~ 6.0 | 5.8 | ||
| Loss on drying | ≤3.5% | 1.9% | ||
| Sulphate(Dried basis) | 16.0%~18.0% | 16.2% | ||
| Sulphated ash | ≤1.0% | 0.59% | ||
| Related substance | Any impurity | ≤ 4.0% | Complies | |
| Total impurities | ≤ 23.0% | 9.7% | ||
| Assay, HPLC(Dried basis) | Sum of E1,E2, E1-I, 1-7MOA, E3 | ≥ 77.0% | 86.2% | |
| E1-I; | ≤ 10.0% | 0.36% | ||
| E1-7MOA; | ≤ 10.0% | 4.3% | ||
| E3; | ≤ 10.0% | 4.6% | ||
| Potency (Moisture) | —— | 22114 | ||
| Potency(Dried basis) | ≥19000IU/mg | 22542.3 | ||
