Bosentan

Solubility

Soluble   in dimethylformamide and acetonitrile, insoluble in water

Identification

IR spectrum corresponds to the IR spectrum of the   reference standard

Heavy metals

NMT 10ppm

Impurities

Impurity E

NMT 0.15%

Impurity D

NMT 0.15%

Impurity B

NMT 0.15%

Impurity A

NMT 0.15%

Impurity C

NMT 0.15%

Any individual unknown impurity

NMT0.05%

Total impurities

NMT0.3%

Water

2.0%~4.0%

Residue on ignition

NMT 0.1%

Limit   of Ethylene glycol

NMT 620ppm

Microbial limits

Total bacterial count NMT 100CFU; Yeast &   Mold NMT 100CFU;

e . coli should be not detected

Assay

98.0%~102.0%