Superiority:
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
Details:
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