Amlodipine Besylate

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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Amlodipine Besylate Structure

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.

Product Highlights

  • High Purity: Assay 98.0%–102.0% (HPLC), meeting USP/EP/BP specifications.
  • Regulatory Support: Full documentation including COA, MSDS, and TDS for regulatory filings.
  • Stable Supply: Commercial-scale production with consistent batch-to-batch quality.
  • Custom Packaging: Available in 25 kg drums, with options for smaller quantities.
  • Technical Service: Dedicated support for formulation and compliance inquiries.

응용 분야

  • Hypertension management in adults and pediatric patients.
  • Chronic stable angina and vasospastic angina.
  • Fixed-dose combination products with ARBs, ACE inhibitors, or statins.
  • Research on calcium channel modulation and cardiovascular therapies.

사양

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

Ordering & Supply

  • 포장: 25 kg fiber drum with double polyethylene bags; custom packaging available.
  • 최소 주문 수량: 1 kg for pilot batches; 25 kg for commercial orders.
  • 리드 타임: 3-5 business days (stock items)
  • 문서: COA, MSDS, TDS, and regulatory support provided.

견적 요청

연락 유지

견적 요청

주소

Room,5-0203, Unit 5, Beiyuanmen Street,Xi'an,Shaanxi,China

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