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CERTIFICATE OF ANALYSIS
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Product name |
Paclitaxel |
Molecular Weight |
|
|
Batch No. |
2020.05.10 |
Certificate No. |
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|
Manu.date |
May 10,2020 |
Expiry |
May 09,2022 |
|
Molecular Formular |
C47H51NO14 |
Quantity |
500g |
|
Text Item |
Specifications |
Results |
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Appearance |
White to Off-white crystalline powder |
conform |
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Solubility |
Solube in alcohol,methanol,chloroform,hardly Solube in water |
conform |
|
|
Specific optical rotation |
-48o～-54o |
-52.2o |
|
|
moisture |
≤4.0% |
0.44% |
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Identification |
A: IR spectrum of the sample preparation should be identical to that of to the standard sample |
conform |
|
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B: The 0.002% w/v solution in methanol exhibits manima 283,275,230nm |
positive |
||
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Chioride |
≤0.1% |
conform |
|
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Purity(HPLC) |
≥99% |
99.8% |
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Related substances |
A:Single Impurity ≤0.3% |
0.03% |
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B:Total Impurities ≤1.0% |
0.20% |
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Residue of ignition |
≤0.2% |
0.02% |
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Residual solvents |
Meet the requirement of ICH |
conform |
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Heavy metals |
≤20ppm |
conform |
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Assay |
98%～102% |
99.8% |
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Conclusion |
The above product conforms to USP38 |
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