CAS Number: 1405-41-0
Gentamicin Sulfate
Appearance: White or almost white crystalline powder
Quality Index Standard Results
Identification: Rule of BP2000 Conforms
Appearance of solution: Rule of BP2000 Conforms
PH: 3.5---4.5 4.3
Specific optical rotation: +107?--+121? +119?
Methanol: Not more than 1.0% Conforms
Composition: C1 : 25.0-50.0% 28.09%
C1a: 10.0-35.0% 25.77%
C2a+ C2: 25.0-55.0% 46.14%
Water: Not more than 15.0% 8.9%
Sulphate Ash: Not more than 1.0% 0.03%
Sulphate: 32.0-35.0% 33.8%
Sterility: Rule of BP2000 Conforms
Bacterial endotoxins: Not more than 0.71 IUE./mg Conforms
Assay: Not less than 590 I.U./mg
(Anhydrous substance) 649 I.U./mg
(Hydrous substance) 591 I.U./mg
Conclusion: The Specification conforms to the rule of BP2000/EPIV.
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