Items | Specifications | Results |
Description | White or almost white Crystal powder;have no smelly and tasteless | White crtystalline powder;have no smelly and tasteless |
Melting temperature | 143~152℃ | 147℃ |
Specific rotation | +24°~+28° | +26° |
Fumarate | 83.7~87.3mg | 85.4mg |
Identification | Complies | Complies |
PH | 3.1-4.1 | 3.7 |
Chromatographic purity | Not more than 1.0% of any identified impurity is found;not more than 0.5% of any unidentified impurity is found;and not more than 3.0% of total impurities is found | Complies |
Color and clarity of solution | ≤0.030(650nm) | 0.010 |
≤0.150(400nm) | 0.030 | |
Limit of residual solvents | Complies | Complies |
Loss on drying | ≤0.5% | 0.2% |
Residue on ignition | ≤0.1% | 0.06% |
Heavy metals | ≤0.001% | <0.001% |
Label Potency | 97.0~102.0% | 99.0% |