Bisoprolol Fumarate
| Nom du produit | Bisoprolol Fumarate |
|---|---|
| Numéro CAS | 104344-23-2 |
| Formule moléculaire | C18H31NO4 · ½ C4H4O4 |
| Poids moléculaire | 766.96 g/mol (as fumarate salt) |
| Apparence | Poudre cristalline blanche à blanc cassé |
| Essai (HPLC) | 98.0% – 102.0% (on dried basis) |
| Perte au séchage | ≤ 0,5% |
| Résidu au feu | ≤ 0,11 TP3T |
| Métaux lourds | ≤ 10 ppm |
| Solubilité | Sparingly soluble in water, freely soluble in methanol, slightly soluble in ethanol |
| Colis | 25 kg net in fiber drum with double polyethylene liner |
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Synonymes : 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.
| Paramètre | Spécifications |
|---|---|
| Assay (HPLC, dried basis) | 98.0% – 102.0% |
| Apparence | Poudre cristalline blanche à blanc cassé |
| Identification | IR and HPLC retention time match reference standard |
| Perte au séchage | ≤ 0,5% |
| Résidu au feu | ≤ 0,11 TP3T |
| Métaux lourds | ≤ 10 ppm |
| Substances apparentées | Each impurity ≤ 0.5%, total ≤ 1.0% |
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