Bumetanide CAS NO.28395-03-1

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