Metoprolol Tartrate
| Nazwa produktu | Metoprolol Tartrate |
|---|---|
| Numer CAS | 56392-17-7 |
| Wzór cząsteczkowy | C15H25NO3·½C4H6O6 |
| Masa cząsteczkowa | 684.82 g/mol (as tartrate salt) |
| Wygląd | Biały lub prawie biały krystaliczny proszek |
| Oznaczenie (HPLC) | 98.5% – 101.5% (on dried basis) |
| Strata przy suszeniu | ≤ 0,5% |
| Popiół po spaleniu | ≤ 0,11 TP3T |
| Metale ciężkie | ≤ 20 ppm |
| Rozpuszczalność | Soluble in water, methanol; slightly soluble in ethanol |
| Wielkość cząstek | D90 ≤ 50 µm (customizable) |
| Opakowanie | Beczka na włókna o pojemności 25 kg z podwójną wkładką z polietylenu |
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Synonimy: Metoprolol tartrate, 56392-17-7, 1-[4-(2-Methoxyethyl)phenoxy]-3-[(1-methylethyl)amino]-2-propanol tartrate, CGP 2175E, Lopressor, Seloken, Betaloc
Metoprolol tartrate is a cardioselective beta-1 adrenergic receptor blocker, structurally characterized by a phenoxypropanolamine core with a methoxyethyl side chain. This molecular configuration confers high affinity for beta-1 receptors located primarily in cardiac tissue, with minimal activity at beta-2 receptors in the lungs and vasculature. The tartrate salt enhances aqueous solubility, facilitating oral and parenteral formulation development.
As a second-generation beta-blocker, metoprolol tartrate is widely prescribed for hypertension, angina pectoris, and heart failure. It is also used in the management of arrhythmias and as an adjunct in myocardial infarction. The compound is available in immediate-release and extended-release forms, with the tartrate salt predominantly used in immediate-release tablets and injection solutions.
For pharmaceutical manufacturers, metoprolol tartrate API offers a well-established synthesis route and consistent crystalline form, ensuring reliable tableting and dissolution performance. Its compatibility with common excipients and stability under typical storage conditions make it a preferred choice for generic and branded formulations alike.
Metoprolol tartrate is a white to off-white crystalline powder with a molecular weight of 684.82 g/mol (as the tartrate salt). It is freely soluble in water and methanol, slightly soluble in ethanol, and practically insoluble in acetone. The tartrate counterion contributes to its stability and solubility profile, which is critical for injectable and oral solid dosage forms. The compound exists as a racemic mixture, with the S-enantiomer carrying the primary beta-blocking activity.
| Parametr | Specyfikacja |
|---|---|
| Oznaczenie (HPLC) | 98.5% – 101.5% |
| Strata przy suszeniu | ≤ 0,5% |
| Popiół po spaleniu | ≤ 0,11 TP3T |
| Metale ciężkie | ≤ 20 ppm |
| Substancje pokrewne | Total impurities ≤ 0.5% |
| Pozostałości rozpuszczalników | Meets ICH Q3C limits |
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