Product Information |
Product name |
Eltrombopag Olamine |
CAS No. |
496775-62-3 |
Molecular Formula |
C25H22N4O4·2(C2H7NO) |
Molecular Weight |
564.6394 |
Molecular Structure |
|
Quality Standard |
99% up by HPLC |
Appearance |
Red to brown powder |
COA |
Product Name: Eltrombopag Olamine |
Batch No.: 202301 |
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Batch Size: 15kg |
Manufacturing Date: 20221202 |
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Test Date:20221218 |
Retest Date: 20231218 |
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Test Items |
Specification |
Test Results |
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Appearance |
Red to brown solid. |
Brown solid |
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Solubility |
Sparingly soluble in methanol or ethanol. |
Sparingly soluble in methanol |
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Identification (by HPLC) |
The retention time of the test product should be consistent with that of the principal peak of the pure reagent. |
The retention time of the test product should be consistent with that of the principal peak of the pure reagent. |
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Related substances |
Largest single impurity |
≤ 0.1% |
0.06% |
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Total impurities |
≤1.0% |
0.09% |
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Purity |
≥ 99.0% |
99.9% |
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Assay |
98.0%-102.0% |
98.6% |
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Residue on ignition |
≤0.2% |
0.04% |
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Loss on drying |
≤0.5% |
0.06% |
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Water |
≤0.5% |
0.06% |
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Heavy metal |
≤ 10ppm |
< 10ppm |
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Residue solvents |
Methanol |
≤0.3% |
0.10% |
|
Ethanol |
≤0.5% |
0.10% |
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Tetrahydrofuran |
≤0.072% |
0.029% |
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Acetic acid |
≤0.5% |
ND |
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Conclusion |
The product conforms to the requirements of Enterprise standard. |
*Products under the patent are only for R&D use