| 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 |