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CERTIFICTE OF ANALYSIS
Product name |
Mitoxantrone Hydrochloride |
Quantity |
5KG |
|
CAS: |
70476-82-3 |
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|
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Batch No. |
221226 |
Report Date |
2022.12.26 |
|
Manufacture Date |
2022.12.26 |
Expiry Date |
2024.12.25 |
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REF .STANDARD |
USP40 |
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Subjects |
Specifications |
Results |
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Characters |
A dark blue powder |
Conforms |
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Solubility: |
sparingly soluble water;slightly soluble in methanol practically insoluble in acetone |
Conforms |
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Identification |
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A: IR |
The same to check sample |
Conforms |
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B: UV |
λmax242nm,275nm 609nm,663nm |
Conforms |
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C: Colour reactions |
Meet the requirement |
Conforms |
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D:Chloride Reactions |
positive |
Conforms |
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Appearance of solution |
clearly and colourless |
Conforms |
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Alcohol |
≤1.5% |
Conforms |
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Acidity(PH) |
3.0-5.0 |
4.3 |
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Loss on drying |
≤6.0% |
3.0% |
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Sulfated ash |
≤0.2% |
0.06% |
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heavy metal |
NMT10ppm |
Conforms |
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Related substances(HPLC) |
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Any single impurity |
≤1.0% |
0.28% |
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Total impurities |
≤2.0% |
1.12% |
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Assay(HPLC) |
97 % ---102% |
99.1% |
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CONCLUSION: |
THE MATERIAL CONFORM WITH USP40 |