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Product Name: Gentamycin Sulfate Expiry Date: 4 Years |
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Analytical Items |
Specifications |
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Characters |
A white or almost white powder, freely soluble in water, practically insoluble in alcohol and in ether |
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Identification |
Positive reaction |
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Appearance of solution |
Clear and not more intensely colored than degree 6 of the range of reference solutions of the most appropriate color |
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Acidity(pH) |
3.5 to 5.5 |
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Specific Optical Rotation |
+107°to +121° |
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Methanol |
Not more than 1.0 percent |
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Composition |
C1 25.0 to 50.0 percent |
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C1n 10.0 to 35.0 percent |
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C2n+C2 25.0 to 55.0 percent |
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Water |
Not more than 15.0 percent |
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Sulfated Ash |
Not more than 1.0 percent |
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Sulfate |
32.0 to 35.0 percent |
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Bacterial endotoxins |
Not more than 1.67 IU/mg |
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Assay |
Not less than 590 IU/mg (Anhydrous substance) |
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Hydrous substance |
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Conclusion |
Complies with the standard of the british pharmacopoeia 2002/european pharmacopocia 4.0. |
