Bumetanide BUMETANIDE 3-(butylamino)-4-phenoxy-5-sulfamoyl-benzoicaci
it conforms to USP34 ,we have GMPand DMF
Appearance |
White or crystal white crystalline powder |
Identification:
Infrared absorption
UV
TLC |
Conforms to the spectrum obtained from bumetanide RS Conforms to the spectrum obtained from bumetanide RS Rf corresponding to standard solution |
Loss on drying |
≤0.5% |
Residue on ignition |
≤0.1% |
Heavy metsal |
≤0.002% |
Related compounds |
Bumetanide related compound A ≤0.1% Bumetanide related compound B≤0.2% Butyl-3-(butylamino)-4-phenoxy-5-sulfamoylbenzoate≤0.1% Any other individual impurity ≤0.2% The sum of all other impurities ≤0.4%(excluding Bumetanide related compound A ,,and Butyl-3-(butylamino)-4-phenoxy-5-sulfamoylbenzoate) |
Particle fineness |
<54µm,≥85% >106µm≤3% |
Toluene residual |
≤500ppm |
3-propylamino-4-phenoxy-5-sulfamylbenzoic acid |
≤0.2% |
Tap bulk density |
0.1-0.3g/ml |
Assay |
98-102% (C17H20N2O5S),calculated on the dried basis |
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