Product Name | Gentamicin sulfate |
Characters | A white or almost white powder,freely,soluble in water, practically insoluble in alcohol and in ether. |
Identification | Tests according to monograph |
Appearance of solution | Clear and not more intensely colored than degree 6 of the range of reference solutions of the most appropriate color |
PH | 3.5 to 5.5 |
Specific optical rotation | +107°to +121° |
Composition
| C1 25.0 to 50.0 percent |
C1a 10.0 to 35.0 percent |
C2a+C2 25.0 to 55.0 percent |
Water | Not more than 1.0 percent |
Sulphated ash: | Not more than 1.0 percent |
Sulphate | 32.0 to 35.0 percent |
Sterility | Complies with the test for sterility |
Bacterial endotoxins | Less than 1.67 IU/mg |
Assay | Not less than 590 IU/mg(anhydrous substance) |