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CERTIFICATE OF ANALYSIS
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Product Name:Gentamycin Sulfate BP2002/EP4.0 |
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Batch No |
20200320 |
Manufacturing Date |
2020.03.20 |
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Reporting No |
20200320 |
Expiry Date |
2024.03.19 |
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Analytical Results |
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Items |
Specifications |
Results |
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Charaters |
A white or almost white powder,freely soluble in water,Practically insoluble in alcohol and in ether. |
complies |
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Indentification |
Positive reaction |
complies |
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Appearance of solution |
Clear and nor more intensely colored than degree 6 of the range of reference solusion of the most appropriate color. |
complies |
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Acidity (PH) |
3.5 to 5.5 |
4.9 |
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Specific optical rotation |
+107° to +121° |
+118° |
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Methanol |
Not more than 1.0 percent |
complies |
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Composition |
C1 25.0 to 50.0 percent |
27.2% |
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C1a 10.0 to 35.0 percent |
21.7% |
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C2a+C2 25.0 to 55.0 percent |
51.2% |
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Water |
Not more than 15.0 percent |
10.7% |
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Sulphate Ash |
Not more than 1.0 percent |
0.2% |
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Sulphate |
32.0 to 35.0 percent |
32.7% |
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Bacterial endotoxins |
Less than 0.71 IU/mg |
complies |
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Assay |
Not less than 590IU/mg(anhydrous substance) |
690IU/mg |
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(anhydrous substance) |
616IU/mg |
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Conclusion:Complies with the standard of BP2002/EP4.0. |
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