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Vinblastine 865-21-4 C46H58N4O9
Vinblastine
Specification |
Items |
Specification |
Results |
Appearance |
A white or light yellow amorphous or crystalline powder |
A light yellow crystalline powder |
Solubility |
Freely soluble in water |
Conforms |
Identification A)Infrared absorption B)Sulfate |
Conforms to the reference standard Conforms to the test for sulfate |
Conforms Conforms |
Ph |
3.5-5.0 |
4.3 |
Loss on drying |
≤15.0% |
7.4% |
Related Substances Any individual impurity Total impurities |
≤1.0% |
0.4% |
≤3.0% |
1.2% |
|
Residual solvent |
|
|
Methanol |
≤3000ppm |
<1ppm |
Ethanol |
≤5000ppm |
1302ppm |
Chloroform |
≤60ppm |
19ppm |
Dichloromethane |
≤600ppm |
<1ppm |
Bacteria |
≤1000cfu/g |
≤10cfu/g |
Fungi |
≤100cfu/g |
≤10cfu/g |
Escherichia coli |
Not found |
Not found |
Bacterial endotoxins |
≤100u/mg |
Conforms |
Assay |
96.0%-102.0% |
101.6% |
Conclusion |
This product conforms to the requirements of USP31 |
Vinblastine
Specification |
Items |
Specification |
Results |
Appearance |
A white or light yellow amorphous or crystalline powder |
A light yellow crystalline powder |
Solubility |
Freely soluble in water |
Conforms |
Identification A)Infrared absorption B)Sulfate |
Conforms to the reference standard Conforms to the test for sulfate |
Conforms Conforms |
Ph |
3.5-5.0 |
4.3 |
Loss on drying |
≤15.0% |
7.4% |
Related Substances Any individual impurity Total impurities |
≤1.0% |
0.4% |
≤3.0% |
1.2% |
|
Residual solvent |
|
|
Methanol |
≤3000ppm |
<1ppm |
Ethanol |
≤5000ppm |
1302ppm |
Chloroform |
≤60ppm |
19ppm |
Dichloromethane |
≤600ppm |
<1ppm |
Bacteria |
≤1000cfu/g |
≤10cfu/g |
Fungi |
≤100cfu/g |
≤10cfu/g |
Escherichia coli |
Not found |
Not found |
Bacterial endotoxins |
≤100u/mg |
Conforms |
Assay |
96.0%-102.0% |
101.6% |
Conclusion |
This product conforms to the requirements of USP31 |
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