Function: | Nervous System Drugs |
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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% |