Item | Specification |
Appearance | White or slightly yellowish powder, hygroscopic |
Mp | About 242℃ |
Solubility | Practically insoluble in water, freely soluble in dimethylformamide, slightly soluble in acetoneand in methanil. |
Identification | Infrared absorption spectrophotometry, Comparison pimobendan CRS. |
The retention time of the major peak of the Sample solution corresponds to that of the Standard stock solution,as obtained in the Organic Impurities test. | |
Heavy metals | ≤10ppm |
Granularity | P90 ≤ 25μ m |
Particle size | 20-80 mesh |
Residual solvents | ≤ 500ppm |
Water | ≤ 1.0% |
Assay | 98.0%~102.0% |
Sulphated ash | ≤ 0.10% |
Related substances (HPLC) | |
impurity A | ≤ 0.10% |
impurity B | ≤ 0.10% |
Any other impurity | ≤ 0.10% |
Total impurity | ≤ 0.20% |