pimobendan pimoben pimobendan powder
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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 |
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