Bisoprolol Fumarate
(C18H31NO4)‧1/2C4H4O4
- CEP number：R1-CEP 2010-344-Rev 01
- USFDA DMF number：20120
- China FDA DMF number：Y20170001503 (5kg/bucket、15kg/bucket), Y20190021601 (20kg/bucket)
Description：
| 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 |
| Identification | ||
| 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% |