Amlodipine Besylate
| Nombre del producto | Amlodipine Besylate |
|---|---|
| Número CAS | 111470-99-6 |
| Sinónimos | Amlodipine benzenesulfonate; Norvasc; Istin; Amlor; UK-4834011 |
| Fórmula molecular | C20H25ClN2O5·C6H6O3S |
| Peso molecular | 567.05 g/mol (free base: 408.88 g/mol) |
| Apariencia | Polvo cristalino de color blanco a blanquecino |
| Ensayo (HPLC) | 98.0%–102.0% (on dried basis) |
| Pérdida por secado | ≤0,51 TP3T |
| Residuo tras la combustión | ≤0,11 TP3T |
| Metales pesados | ≤10 ppm |
| Solubilidad | Slightly soluble in water; freely soluble in methanol, ethanol, and chloroform |
| Paquete | 25 kg net in fiber drum with double polyethylene bags |
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Sinónimos: Amlodipine benzenesulfonate, Norvasc, Istin, Amlor, UK-4834011
Amlodipine Besylate is the besylate salt of amlodipine, a dihydropyridine calcium channel blocker. It is a white to off-white crystalline powder, practically insoluble in water but freely soluble in organic solvents such as methanol and chloroform. The compound is manufactured under cGMP conditions and is available in pharmacopeial grades (USP/EP/BP) suitable for oral solid dosage forms.
As a long-acting antihypertensive, amlodipine besylate is a cornerstone in the management of hypertension and angina. Its high protein binding and slow hepatic metabolism allow for once-daily dosing, making it a preferred choice for both monotherapy and fixed-dose combinations. The API is widely used in tablet formulations, often co-formulated with agents like valsartan, olmesartan, or atorvastatin to enhance therapeutic outcomes.
| Parámetro | Especificaciones |
|---|---|
| Ensayo (HPLC) | 98.0%–102.0% |
| Identificación | IR, HPLC retention time |
| Pérdida por secado | ≤0,51 TP3T |
| Residuo tras la combustión | ≤0,11 TP3T |
| Metales pesados | ≤10 ppm |
| Organic Impurities | Meets USP/EP requirements |
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