Pimobendan EP standard CAS:74150-27-9

Product name:Pimobendan

CAS:74150-27-9

Purity:99%

ITEMS                              SPECIFICATION                         RESULTS

Appearance               White or slightly yellowish powder,

hygroscopic powder                                  White powder                     

Identification A: Infrared absorption spectrophotometry

Comparison:pimobendan CRS.                       Conforms

B: The retention of the major peak of the sample

solution corresponds to that of the standard

Stock solution,as obtained in the Organic

Impurities test.                                      Conforms

Solubility:                  Practically insoluble in water,freely soluble in

dimethylformamide,slightly soluble in acetone

and in methanol.                                      Conforms 

Melting point               about:242°c                                          242°c 

Related substances(HPLC)  

Impurity A                 ≤0.10%                                           N.D.

Impurity B                 ≤0.10%                                           N.D.

Any other Impurity          ≤0.10%                                           0.08%

Total Impurities             ≤0.20%                                           0.10%

Assay(on anhydrous basis)  98.0%-102.0%                                    99.90%

Residual solvent            ≤500ppm                                           <500ppm

Heavy Metals               ≤10ppm                                           <10ppm

Granularity                 P90 ≤25um                                         <25um

Water                    ≤1.0%                                           0.20%

Selective inhibitor of phosphodiesterase III (PDE III). To begin treatment of congestive heart failure caused by dilated cardiomyopathy in dogs or valvular insufficiency (mitral or tricuspid regurgitation).