ITEM

SPECIFICATIONS

RESULTS

Appearance

White or slightly yellowish powder .hygroscopic

White powder

mp

About 242 ℃

242 ℃

Solubility

Practically insoluble in water ,freely soluble in dimethylformamide,slightly soluble in acetone and in methanol

Conforms

Identification

Infrared absorption ,spectrophotometry,

comparison pimobendan CRS

Conforms

Heavy Metals

≤10ppm

Conforms

Granularity

P90 ≤25um

Conforms

 Residual solvent

≤500ppm

Conforms

Water

≤1.0%

0.08%

Assay (HPLC)

98.0% ~ 101.0%

99.62%

Sulphated ash

≤0.1%

0.07%

Related Substances (HPLC)

Impurity A : ≤0.1%

ND

Impurity B :≤0.1%

ND

Any other impurities :≤0.1%

0.06%

Total impurities :≤0.2%

0.13%

Conclusion: Conforms to the standard of EP9.0