| tem | Standard | Result | |||
| Characters | White crystalline powder | White crystalline powde | |||
| Solubility | 1g of the specimen dissolves in 20ml boil water, 15ml 1mol/L sodium hydroxide solution, freely soluble in alcohol. | Conforms | |||
| Identification |
A:Melting range 168-172℃ B.C.D.E Positive |
169.6-170.3℃ B.C.D.E Positive |
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| Related subtances | Impurity J(chloracetanilide)≤10ppm | <10ppm | |||
| Impurity K(4-aminophenol)≤50ppm | <50ppm | ||||
| Impurity F(4-nitrophenol)≤0.05% | <0.05% | ||||
| Any other impurity≤0.05% | <0.05% | ||||
| Total of other impurity ≤0.1% | <0.1% | ||||
| Chloride | ≤0.014% | <0.014% | |||
| Sulfate | ≤0.02% | <0.02% | |||
| Sulfide | Complies | Complies | |||
| Heavy metals | ≤0.001% | <0.001% | |||
| Free p-Aminophenol | ≤0.005% | <0.005% | |||
| Chloracetanilide | ≤0.001% | <0.001% | |||
| Readily carbonizable substances | Complies | Complies | |||
| Residual solvent | Residual content of acetic acid ≤0.5% | <0.11% | |||
| Organic volatile impurities | Complies | Complies | |||
| Water | ≤0.5% | 0.11% | |||
| Residue on ignition | ≤0.1% | 0.03% | |||
| Assay | 99.0-101.0%(Dried substance) | 100.2% | |||
| Conclusion | It complies with requirements of the BP2012/USP35 | ||||
