China Mycophenolate Mophetil CAS No. 115007-34-6, Find details about China 115007-34-6, Mycophenolate Mophetil from Mycophenolate Mophetil CAS No. 115007-34-6
Items | Standard | Results |
Appearance | White or almost white,crystalline powder;odorless | Almost white crystalline powder;odorless |
Solubility | Freely soluble in acetone,sparingly soluble in anhydrous ethanol,practically insoluble in water | / |
Melting point | About 96ºC | 95.5~96.5ºC |
Identification | ||
IR | Conform to the CRS | Conform |
Appearance of solution | The solution is clear and colorless | Conform |
Loss on drying | Not more than 0.5% | Less than 0.1% |
Sulfated ash | Not more than 0.1% | Less than 0.1% |
Related substances | ||
Impurity F | Not more than 0.5% | 0.03% |
Impurity B | Not more than 0.2% | Not detected |
Impurity A | Not more than 0.1% | Not detected |
Impurity D | Not more than 0.1% | Not detected |
Impurity E | Not more than 0.1% | Not detected |
Impurity G | Not more than 0.1% | Not detected |
Impurity H | Not more than 0.1% | Not detected |
Any other impurity | Not more than 0.1% | Not detected |
Total impurities | Not more than 0.7% | Less than 0.1% |
Residual solvents | ||
Toluene | Not more than 0.089% | 0.001% |
Dimethybenzene | Not more than 0.03% | Not detected |
Isopropanol | Not more than 0.5% | Less than 0.1% |
Microbial limit | TAMC:Not more than103 CFU/g | Less than 10 CFU/g |
TYMC:Not more than 102 CFU/g | Less than 10 CFU/g | |
Escherichia coli:Not detected | Not detected | |
Assay (dried substance) | 98.0%~102.0% | 100.6% |