| Customization: | Available |
|---|---|
| CAS No.: | 1405-20-5 |
| Formula: | C56h100n16o17s |
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| Items | Requirements | Result |
| Appearance | White or almost white powder hygroscopic | Conforms |
| Solubility | Soluble in water, slightly soluble in alcohol. | Conforms |
| Identification |
A. The retention times of the major peaks from the sample solution correspond to those of the standard solution, as obtained in the test for composition of Polymxins.
B. To the sample solution add 5ml of 2.5N sodium hydroxide, and mix, add 5 drops of 10mg/ml of cupric sulfate shaking after the addition of each drop, a reddish-violet color is produced.
C. It gives reaction of sulphate.
|
Conforms |
| PH | 5.0~7.5 | 5.4 |
| Loss on drying | NMT 7.0% | 3.0% |
| Residue on ignition | NMT 5.0% | 0.20% |
| Assay (on the dried basis) | Not less than 6000IU/mg | 8254IU/mg |
| Related substances | Any impurity: NMT 3.0% | 1.8% |
| Total impurity: NMT 17.0% | 4.1% | |
| Composition of Polymyxins | B3: NMT 6.0% | 1.4% |
| B1-I: NMT 15.0% | 8.1% | |
| Sum of B1, B2, B3 and B1-I: NLT 80.0% | 94.0% | |
| Conclusion | The result conforms to the standard of USP43. | |
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