| Function: | Drug Treatment of Mental Disorder |
|---|---|
| Grade Standard: | Medicine Grade |
| Type: | Chemical Reagent |
| State: | Powder |
| Volatile: | Not Volatile |
| Transport Package: | Bag |
| Samples: |
|---|
Suppliers with verified business licenses
Audited Supplier | 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% |
|
| 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 |
Suppliers with verified business licenses
Audited Supplier 
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