Function: | Drug Treatment of Mental Disorder |
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Grade Standard: | Medicine Grade |
Type: | Chemical Reagent |
State: | Powder |
Volatile: | Not Volatile |
Transport Package: | Bag |
Samples: |
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According to | EP8.0 | |
Items | Standard | Results |
Characters | Appearance :White or almost white powder | Almost white powder |
Solubility :practically insoluble in water,freely soluble in methylene chloride,sparingly soluble in ethanol(96 per cent) | practically insoluble in water,freely soluble in methylene chloride,sparingly soluble in ethanol(96 per cent) | |
Identification Infrared Absorption |
Conforms to spectrum of Risperidone CRS | Conforms to spectrum of Risperidone CRS |
Appearance of Solution | The solution is clear and colourless | clear and colourless |
Loss on drying | NMT 0.5% | 0.01% |
Sulfated ash | NMT 0.1% | 0.06% |
Residual solvents | Ethanol NMT 0.5% | 0.1% |
N,N-dimethylformamide NMT 0.088% | 0.0004% | |
Related substances | Impurity A NMT 0.2% | 0.02% |
Impurity B NMT 0.2% | 0.04% | |
Impurity C NMT 0.2% | Undetected | |
Impurity D NMT 0.2% | Undetected | |
Impurity E NMT 0.2% | Undetected | |
Impurity K NMT 0.15% | Undetected | |
Single unknown impurity NMT 0.10% | RRT=1.10:0.02%;RRT=1.18:0.02% RRT=1.23:0.03%;RRT=1.60:0.01% |
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Total impurities NMT 0.3% | 0.14% | |
Assay | 99.0 per cent to 101.0 per cent (dried substance) | 100.5% |
Hydroxylamine hydrochloride |
NMT 90ppm | Undetected |
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