appearance pale yellow crystalline powder
assay, on dried basis 98.0-101.0%
identification meets the requirements
melting range 110-114℃( does not exceed 2℃)
loss on drying not more than 0.5%
related compounds 4-nitro-3-trifluoro-methylacetanilide:0.2%max
4-nitro-3-trifluoro-methylaniline:0.15% max
3-trifluoromethylaniline: 0.2% max
4-nitro-3-trifluoromethylpropionanilide: 0.3% max
3-trifluoromethylisobutyranilide: 0.2% max
o-flutamide:nmt: 0.2%
unknown(relative response:1.0) :0.05%max
total unknown: 0.1% max
total impurities: 0.4% max
methanol:3000ppm max
residue on ignition not more than 0.1%
residual solvents methanol:nmt:3000ppm
solubility freely soluble in acetone ethyl acetate soluble in chloroform other practically insoluble mineral oil. petroleum ether and water
heavy metals not more than10ppm
conclusion complies with usp36