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CERTIFICATE OF ANALYSIS
2019.12.09
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Product Name |
Dexamethasone sodium phosphate |
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Batch No |
201901209 |
Test Date |
2019.12.24 |
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Quantity |
10kg |
According to |
BP2005 |
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MFG. Date |
2019.12.24 |
Exp Date |
2021.12.24 |
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Test Items |
Specification |
Test Results |
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Character |
White or almost white powder |
Almost white powder |
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Identification |
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(1) |
Complies by IR |
Conforms |
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(2) |
Complies by TLC |
Conforms |
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Test |
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PH |
7.5 to 9.5 |
8.6 |
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Specific optical retation |
+76o to +82o |
+78.9o |
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Related substances |
Only one principal impurity more than 1.0% and not more than 2.0% |
Conforms |
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Other impurity not more than 1.0% |
Conforms |
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Inorganic phosphates |
Not more than 1.0% |
Conforms |
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Ethanol |
Not more than 5000ppm |
Undetected |
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Ethanol and water |
Not more than 16.0% |
3.6% |
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Assay |
Contains 97.2% to 102.8% of C22H28FNa2O8P calculated with anhydrous ethanol-free |
98.0% |
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Conclusion |
The goods conforms to BP2005 |
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