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 |