Name | Pemetrexed disodium |
CAS NO | 150399-23-8 |
Appearance | White crystalline powder |
Identification | meet the requirement |
Loss on drying | 0.5%max |
Residue on ignition | 0.5%max |
Havy metals | 10ppm max |
Assay | 99%min |
Application
This product is suitable for combination therapy with cisplatin inoperable malignant pleural mesothelioma.
Certificate of Analysis
Test Items |
Standard |
Test Results |
Character |
Almost-white or light yellow unfixed powder, smell-less, hygroscopic freely. |
white unfixed powder, smell-less, hygroscopic freely. |
Solubility |
Soluble in water very freely, hardly soluble in ethanol or chloroform or . |
Conforms |
PH |
6.5-8.5 |
7.2 |
Clarity and color of solution |
Meet the requirements. |
Conforms |
Related substance |
Max single impurity≤0.1% |
0.036% |
Total impurity≤0.5% |
0.17% |
|
Heavy Metal |
<20ppm |
Conforms |
Water |
7.2%-10.2% |
8.8% |
Chloride |
≤0.02% |
Conforms |
Ethanol |
≤5000ppm |
1687ppm |
Dichloromethane |
≤600ppm |
Not Detected |
N,N-Dimethylformamide |
≤880ppm |
Not Detected |