Application: Effective drugs for the treatment of paralysis agitans, mainly used for Parkinson's syndrome and so on
Items | Specifications | Results | ||
Characters | Appearance | White or almost white, crytalline powder | Almost white crytalline powder | |
Solubility | Slightly soluble in water, practically insoluble in ethanol(96 per cent).It is freely soluble in 1 M hydrochloric acid and sparingly soluble in 0.1 M hydrochloric acid. | Meets the requirements | ||
Identification | A、IR | The sample comparing with the spectrum obtained with standard | Complies | |
Appearance of solution | Clear and not more than reference solution BY6 | Meets the requirements | ||
PH | 4.5-7.0 | 5.0 | ||
Related compounds | Impurity A: Not more than 0.1% | Undetected | ||
Impurity B: Not more than 0.5% | Undetected | |||
Impurity C: Not more than 0.2% | Undetected | |||
Unspecified impurities: Not more than 0.05% | 0.02% | |||
Total impurities: Not more than 1.0% | 0.04% | |||
Enantiomeric purity | Not more than 0.5% | 0.03% | ||
Heavy metal | Not more than 0.001% | Less than 0.001% | ||
Loss on drying | Not more than 1.0% | 0.2% | ||
Sulphated ash | Not more than 0.1% | 0.04% | ||
Residual solvents | Methanol | Not more than 3000ppm | Below LOD | |
Assay | 99.0%-101.0% | 99.4% |