Appearance

White or slightly   yellowish Powder,hygroscopic.

White powder

Related substances(HPLC)

Impurity A≤0.10

Not detected

Impurity B≤0.10

Not detected

Any other impurity≤0.10

0.01%

Total impurity ≤0.20%

0.08%

Melting   point

About 242℃

242℃

Solubility

Practically insoluble in water,freely soluble in dimethylformamide,

slightly soluble in acetoneand in methanol.

conforms

Water

≤1.0％

0.08%

Heavy metals

≤10ppm

conforms

Sulphated   ash

≤0.1％

0.09%

Identification

Infrared absorption   spectrophotometry,

Comparisonpimobendan CRS.

conforms

Assay

98.0-101％

99.68%

Conclusion

THE PRODUCT CONFORMS   TO THE EP10.0