Bisoprolol Fumarate
(C18H31NO4)‧1/2C4H4O4
產品說明：
| 分子式 | (C18H31NO4)‧1/2C4H4O4 |
| 分子量 | 766.98 |
| 化學名 | 2-Propanol,1-[4-[[2-(1-methylethoxy)ethoxy]methyl] phenoxy]-3-[(1-methylethyl)-amino]-,(±)-,(E)-2-butenedioate (2:1) (salt) |
| 活性成份 | Bisoprolol Fumarate contains the equivalent of not less than 831μg of bisoprolol(C18H31NO4) per mg，calculated on the anhydrous basis. |
| 藥理 | 本品為β－1選擇性腎上腺素接受體阻斷劑。 |
| 適應症 | 高血壓、狹心症。 |
| 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% |