Amlodipine Besylate
| 제품명 | Amlodipine Besylate |
|---|---|
| CAS 번호 | 111470-99-6 |
| 동의어 | Amlodipine benzenesulfonate; Norvasc; Istin; Amlor; UK-4834011 |
| 분자식 | C20H25ClN2O5·C6H6O3S |
| 분자량 | 567.05 g/mol (free base: 408.88 g/mol) |
| 외관 | 흰색에서 미백색의 결정성 분말 |
| 분석법 (HPLC) | 98.0%–102.0% (on dried basis) |
| 건조 손실 | ≤0.5% |
| 소각 잔류물 | ≤0.1% |
| 중금속 | ≤10 ppm |
| 용해도 | Slightly soluble in water; freely soluble in methanol, ethanol, and chloroform |
| 패키지 | 25 kg net in fiber drum with double polyethylene bags |
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동의어: 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.
| 매개변수 | 사양 |
|---|---|
| 분석법 (HPLC) | 98.0%–102.0% |
| 식별 | IR, HPLC retention time |
| 건조 손실 | ≤0.5% |
| 소각 잔류물 | ≤0.1% |
| 중금속 | ≤10 ppm |
| Organic Impurities | Meets USP/EP requirements |