Bisoprolol Fumarate
  • CEP number:R1-CEP 2010-344-Rev 01
  • USFDA DMF number:20120
  • China FDA DMF number:Y20170001503 (5kg/bucket、15kg/bucket), Y20190021601 (20kg/bucket)


Molecular Formula (C18H31NO4)‧1/2C4H4O4
Molecular Weight 766.98
Chemical name 2-Propanol,1-[4-[[2-(1-methylethoxy)ethoxy]methyl]
phenoxy]-3-[(1-methylethyl)-amino]-,(±)-,(E)-2-butenedioate (2:1) (salt)
Active ingredient Bisoprolol Fumarate contains the equivalent of not less than 831μg of bisoprolol(C18H31NO4) per mg,calculated on the anhydrous basis.
Application Anithypertensive、Angina pectoris。
item Specification Result
Appearance White crystalline powder White crystalline powder
a. IR Conform to the reference standard spectrum Conforms
b. HPLC The retention time of the major peak in the chromatogram of the Assay preparation corresponds to that in the chromatogram of the standard preparation, as obtained in the Assay Conforms
Specific rotation -2° ~ +2° 0.09862
Water (Karl Fischer) No more than 0.5 % 0.280%
Residue on ignition No more than 0.1 % 0.020%
Heavy metals No more than 0.002 % Pass
Related substances No more than 0.5 % 0.238%
Content of fumaric acid Between 14.8 % and 15.4 % 15.30%
Residual solvent
Toluene No more than 890 ppm Undetected
Isopropyl alcohol No more than 5000 ppm Undetected
Acetone No more than 5000 ppm Undetected
2-isopropoxyethanol No more than 100 ppm Undetected
Assay 97.5-102.0% 99.50%