Items
Specification
Results
Appearance
White or slightly yellowish Powder,hygroscopic.
White powder
Related substances(HPLC)
Impurity A≤0.10
Not detected
Impurity B≤0.10
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%
Heavy metals
≤10ppm
Sulphated ash
≤0.1%
0.09%
Identification
Infrared absorption spectrophotometry,
Comparisonpimobendan CRS.
Assay
98.0-101%
99.68%
Conclusion
THE PRODUCT CONFORMS TO THE EP10.0
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