Gentamycin sulphate CAS NO.1405-41-0 Gentamycin Sulfate 1405-41-0
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Item |
Specifications |
Results |
Characters |
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 to 5.5 |
4.4 |
Specific optical rotation |
+107°to +121° |
+117° |
Methanol |
Not more than 1.0 percent |
Complies |
Composition |
C1:25.0 to 55.0 percent |
27.5% |
C1a:10.0 to 35.0 percent |
30.1% |
|
C2a +C2:25.0 to 55.0 percent |
42.4% |
|
Water |
Not more than 15.0 percent |
8.6% |
Sulphated ash |
Not more than 1.0 percent |
0.4% |
Sulphate |
32.0 to 35.0 percent |
33.4% |
Sterility |
Complies with the test for sterility |
Complies |
Bacterial endotoxins |
Less than 1.67 IU/mg |
<0.71 IU/mg |
Assay |
Not less than 590 IU/mg(anhydrous substance) |
670 IU/mg |
(hydrous substance) |
612 IU/mg |
|
Conclusion |
The results conforms with BP2002/EP4 standards. |
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