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1.1405-41-0/GentamycinSulfate 2.Whiteoralmostwhitepowder 3.Packing:1kg/AluminumTin 4.Purity:590IU/mg 5.GMPCertified …
1. 1405-41-0/Gentamycin Sulfate
2. White or almost white powder
3. Packing: 1kg/Aluminum Tin
4. Purity: 590 IU/mg
5. GMP Certified
6.Specification
Characters | A white or almost white powder, freely soluble in water, Practically insoluble in alcohol and in ether | Complies |
Identification | Tests according to monograph | Complies |
Appearance of solution | Clear and not more intensely colored than degree 6 of the range of reference solutions of the most appropriate color | Complies |
PH | 3.5-5.5 | 4.7 |
Specific optical rotation | +107° to +121° | +117° |
Methanol | Not more than 1.0% | Complies |
Composition | C1 25.0 to 50.0% C1a 10.0 to 35.0% C2a+C2 25.0 to 55.0% | 25.3% 27.8% 46.9% |
Water | Not more than 15% | 9.6% |
Sulphated ash | Not more than 1.0% | 0.2% |
Sulphate | 32.0 to 35.0% | 34.3% |
Sterility | Complies with the test for sterility | Complies |
Bacterial endotoxin | Not more than 0.71 IU/mg | Complies |
Assay | Not less than 590 IU/mg (anhydrous substance) (hydrous substance)
|
666 IU/mg 602 IU/ |
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