China Mycophenolate Mofetil (EP6) CAS: 115007-34-6, Find details about China Mycophenolate Mofetil, 115007-34-6 from Mycophenolate Mofetil (EP6) CAS: 115007-34-6
TEST ITEMS | SPECIFICATIONS | RESULTS |
Appearance | A white or almost white, crystalline powder | Almost white crystalline powder |
Identification (IR spectrum) | Comparison: mycophenolate mofetil CRS | Conform |
Appearance of solution | Clear and colourless | Conform |
Related substances (HPLC) | Impurity F ≤0.5 % | 0.11 % |
Impurity B ≤0.2 % | ND | |
Impurity A,D,E,G,H ≤0.1% (each) | ND | |
Any other impurity ≤0.1% (each) | ND | |
Total ≤0.7 % | 0.11 % | |
Heavy metals | ≤20 ppm | <20 ppm |
Loss on drying | ≤0.5 % | 0.04 % |
Sulphated ash | ≤0.1% | 0.02 % |
Assay (dried substance) | 98.0% ~ 102.0% | 99.0 % |
Residual solvents | Xylene ≤ 2170 ppm | Conform |
Ethyl acetate ≤5000 ppm | Conform | |
CONCLUSION | CONFORM TO EP6 |