Colistin Sulfate pure / 10% premix
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Item |
Standard |
Results |
Remark |
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Appearance |
White or almost white, hygroscopic powder |
Conforms |
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Solubility |
Freely soluble in water, practically insoluble in acetone and in ethanol(96%) |
Conforms |
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Identification |
The peaks due to polymyxin E1 and polymyxin E2 in the chromatogram obtained with the test solution are similar in retention time to the corresponding peaks in the chromatogram obtained with reference solution(a) |
Conforms |
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It gives reaction (a) of sulfates |
Conforms |
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pH |
4.0~6.0 |
4.65 |
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HPLC Composition |
Sum of polymyxins E4 and E2-Val ≤3.0% |
1.7%% |
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Polymyxin E6 ≤4.5% |
1.8% |
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Polymyxin E2-1 ≤2.5% |
0.94% |
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Polymyxin E3 ≤5.5% |
4.8% |
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Polymyxin E1-Nva ≤4.5% |
0.65% |
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Polymyxin E1-1 ≤8.5% |
0.68% |
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Polymyxin 2,3-dehydro E1 ≤1.5% |
0.74% |
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Polymyxin E1-7MOA ≤5.0% |
4.2% |
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Sum of polymyxins E1,E2,E3,E4,E6,E1-7MOA E1-1,E1-Nva,E2-l,E2-Val and 2,3-dehydro E1 ≤86.0% |
90.9% |
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Related substances |
Impurity B ≤5.0% |
N.D |
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Any other impurity (Not more than 4 such impurities exceed 1.0%) |
Conforms |
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Total impurities ≤11.0% |
7.4% |
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Sulphate(Dried substance) |
16.0-18.0% |
16.8 |
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Loss on drying |
≤3.5% |
3.0% |
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Sulphate ash |
≤1.0% |
0.49% |
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Assay(Dried substance) |
≥19000 IU/mg% |
23093 |
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Conclusion |
The batch product complies with Ph.Eur.9.7 |
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