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CERTIFICATE OF ANALYSIS
Vincristine Sulphate USP
|
Batch number |
20220816 |
Manufacture date |
2022.08.28 |
|
Batch size |
200g |
Test date |
2022.09.10 |
|
quantity |
188.96g |
Report date |
2022.09.20 |
|
Reference |
USP |
Retest date |
2024.08.27 |
|
Items |
Specification |
Result |
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|
characters |
Appearance |
White or slightly yellowish.powder very hygroscopic. |
White powder |
|
Solubility |
Freely soluble in water,soluble in methanol,slightly soluble in alcohol. |
Conforms |
|
|
Identification |
A .infrared absorption |
The IR spectrum of the substance to be examined corresponds to that of the Ph.Eur.reference spectrum of vincristine sulphate. |
Conforms |
|
B.Reaction of sulphate |
Positive for sulphate |
Positive |
|
|
Tests |
pH |
3.5~4.5(1.0mg/ml in water) |
4.5 |
|
Related substances |
Other individual impurities:≤1.0% |
0.41% |
|
|
Total inpurity：≤4.0% |
1.9% |
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|
Residual organic solvent |
Methanol：≤3000ppm |
64ppm |
|
|
Ethanol ：≤5000ppm |
2597ppm |
||
|
Chloroform：≤600ppm |
182ppm |
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Chloroform：≤60ppm |
48ppm |
||
|
Tetrahydrofuran：≤720ppm |
5ppm |
||
|
Loss on drying |
≤12.0% |
6.4% |
|
|
Bacterial endotoxins |
≤20EU/mg |
Conforms |
|
|
Microbial limit |
Total viable acrobic count （acrobic bacteria plus fungi）：≤100CFU/g |
10CFU/g |
|
|
Psendomonas aeruginosa：Absence/g |
Absence/g |
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|
Staphylococcus aurens：Absence/g |
Absence/g |
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|
Enterobacteria：Absence/g |
Absence/g |
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|
Assay |
95.0%~104.0%（calculated with reference to the dried substance.） |
98.0% |
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