Bisoprolol Fumarate
| Nazwa produktu | Bisoprolol Fumarate |
|---|---|
| Numer CAS | 104344-23-2 |
| Wzór cząsteczkowy | C18H31NO4 · ½ C4H4O4 |
| Masa cząsteczkowa | 766.96 g/mol (as fumarate salt) |
| Wygląd | Biały lub prawie biały krystaliczny proszek |
| Oznaczenie (HPLC) | 98.0% – 102.0% (on dried basis) |
| Strata przy suszeniu | ≤ 0,5% |
| Popiół po spaleniu | ≤ 0,11 TP3T |
| Metale ciężkie | ≤ 10 ppm |
| Rozpuszczalność | Sparingly soluble in water, freely soluble in methanol, slightly soluble in ethanol |
| Opakowanie | 25 kg net in fiber drum with double polyethylene liner |
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Synonimy: Bisoprolol fumarate, 104344-23-2, EMD 33512, Bisoce, Bisoprolol hemifumarate, (±)-1-[4-[[2-(1-Methylethoxy)ethoxy]methyl]phenoxy]-3-[(1-methylethyl)amino]-2-propanol fumarate
Bisoprolol fumarate is a synthetic, cardioselective beta-1 adrenergic receptor blocker belonging to the aminoxypropanol class. It is supplied as a white to off-white crystalline powder, manufactured under cGMP conditions and tested to meet or exceed current pharmacopoeial standards (USP/EP).
As a highly selective beta-1 antagonist, bisoprolol fumarate is a cornerstone API for the treatment of hypertension, chronic stable angina, and heart failure. Its balanced lipophilicity and long half-life make it suitable for once-daily dosing, and it remains a preferred choice among healthcare professionals for cardiovascular management.
| Parametr | Specyfikacja |
|---|---|
| Assay (HPLC, dried basis) | 98.0% – 102.0% |
| Wygląd | Biały lub prawie biały krystaliczny proszek |
| Identyfikacja | IR and HPLC retention time match reference standard |
| Strata przy suszeniu | ≤ 0,5% |
| Popiół po spaleniu | ≤ 0,11 TP3T |
| Metale ciężkie | ≤ 10 ppm |
| Substancje pokrewne | Each impurity ≤ 0.5%, total ≤ 1.0% |
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