| Function: | Nervous System Drugs |
|---|---|
| Certification: | GMP |
| Grade Standard: | Medicine Grade |
|
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| Items | Specification | Results |
| Appearance | White powder of crystalline powder | White crystalline powder |
| Specific optical rotation | +36°~+43° | +41.0° |
| IDENTIFICATION | ||
| HPLC | The retention time of the major peak of the sample solution corresponds to that of the system suitability solution,as obtained in the test for Enatiomeric. | Complies |
| UV | The UV absorption spectra of the test solution exhibit maximum absorption at 266nm,273nm and 282nm. | Complies |
| IR | IR spectrum of sample conforms to that of reference standard. | Complies |
| Reaction of chlorides | A solution of it responds to the tests for Chloride. | Complies |
| TESTS | ||
| Appearance of solution | Clear;not more intensely coloured than Y2 or GY2 | Complies |
| Related substances | ||
| Impurity A | NMT 0.2% | 0.01% |
| Impurity B | NMT 0.2% | Not found |
| Impurity C+D | NMT 0.8% | 0.02% |
| Impurity F | NMT 0.2% | Not found |
| 0.03%(RRT:0.95) | ||
| Any other detectable impurity | NMT 0.1% | 0.03%(RRT:1.2) |
| 0.03%(RRT:1.3) | ||
| Total impurities | NMT 1.5% | 0.15% |
| Impurity E | NMT 0.2% | Not found |
| Enantiomeric | NMT 1.0% | 0.02% |
| Residual solvents | ||
| Methanol | NMT 0.3% | Not found |
| Ethanol | NMT 0.5% | 0.0636% |
| n-Butanol | NMT 0.5% | Not found |
| Tetrahydrofuran | NMT 0.072% | Not found |
| Toluene | NMT 0.089% | Not found |
| Ethyl acetate | NMT 0.5% | Not found |
| Ether | NMT 0.5% | 0.0007% |
| Chloroben | NMT 0.036% | Not found |
| N-methyl formamide | NMT 0.088% | Not found |
| Loss on drying | NMT 0.5% | 0.08% |
| Residue on ignition | NMT 0.1% | 0.03% |
| Heavy metals | NMT 0.001% | Less than 0.001% |
| Assay(on anhydrous basis) | NLT 98.5% of C17H17Cl2N·HCl | 99.6% |
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