Febuxostat
Certificate of Analysis
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Product Name： |
Febuxostat |
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CAS Number: |
144060-53-7 |
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Country Origin： |
China |
Packing: |
1kg/bag |
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Representative Qty.： |
41.7kgs |
Batch Number： |
2023020907 |
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Manufacture Date： |
Feb 09,2023 |
Expiry Date: |
Feb 08,2025 |
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ITEM |
SPECIFICATION |
RESULT |
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Description |
White or off- white crystalline powder |
Off- white crystalline powder |
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Solubility |
This product is easily soluble in N,N-dimethlformamide, dimethylsulfoxide, slightly soluble in methanol or acetonitrile, very slightly soluble in ethanol, and almost insoluble in water |
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Melting point |
207℃~211℃ |
208.7℃~208.8℃ |
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Identification |
IR&HPLC&UV |
Complies |
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Loss on Drying |
≤2% |
0.4% |
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Residue on Ignition |
≤0.1% |
0.04% |
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Heavy metals (as Pb) |
≤20ppm |
<10ppn |
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Chloride |
≤0.01ppm |
<0.05ppm |
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Related substances |
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API-A |
≤0.1% |
Negative |
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API-B |
≤0.1% |
Negative |
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API-C |
Negative |
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API-D |
≤0.1% |
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API-E |
≤0.1% |
Negative |
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IM1 |
≤0.1% |
Negative |
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IM2 |
≤0.1% |
Negative |
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IM3 |
≤0.1% |
0.036% |
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Other single Impurities |
≤0.1% |
0.05% |
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Total Impurities |
≤0.5% |
0.28% |
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Residual solvents |
Ethanol≤0.5% |
Negative |
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N,N-Dimethylformamide ≤0.088% |
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Assay |
Caculated on anhydrous basis, 98%~101% |
99.8% |
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