Gentamicin Sulfate 1405-41-0 Gentamycin sulfate
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ems | Specifications | Testing Results |
Appearance | White or almost white powder | Conforms |
Identification | Tests according to monograph | Conforms |
Solubility | Soluble in water, insoluble in acetone,chloroform either | Conforms |
PH | 3.5-5.5 | 4.5 |
Specific optical rotation |
10%(w/v) water solution +107°TO +121° |
+116° |
Sulphate ash | ≤1.0% | 0.2% |
Sulphate | 32.0%~35.0% | 34.5% |
Composition: C1= C1a= C2a+C2= |
25%~50% 10%~35% 25%~55% |
25.4% 25.7% 48.9% |
Sterility | Complies with the test for sterility | Complies |
Bacterial endotoxin | Not more than 1.0 iu/mg | <0.75iu/mg |
Assay(on dried basis) | ≥680IU/MG | 695IU/MG |
Conclusion | Confirm with the standard of EP 8.0 |
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