Amlodipine Besylate

Amlodipine Besylate

Nom du produit Amlodipine Besylate
Numéro CAS 111470-99-6
Synonymes Amlodipine benzenesulfonate; Norvasc; Istin; Amlor; UK-4834011
Formule moléculaire C20H25ClN2O5·C6H6O3S
Poids moléculaire 567.05 g/mol (free base: 408.88 g/mol)
Apparence Poudre cristalline blanche à blanc cassé
Essai (HPLC) 98.0%–102.0% (on dried basis)
Perte au séchage ≤ 0,51 TP3T
Résidu au feu ≤ 0,11 TP3T
Métaux lourds ≤ 10 ppm
Solubilité Slightly soluble in water; freely soluble in methanol, ethanol, and chloroform
Colis 25 kg net in fiber drum with double polyethylene bags

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Amlodipine Besylate Structure

Synonymes : 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.

Applications

  • 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.

Caractéristiques techniques

Paramètre Spécifications
Essai (HPLC) 98.0%–102.0%
Identification IR, HPLC retention time
Perte au séchage ≤ 0,51 TP3T
Résidu au feu ≤ 0,11 TP3T
Métaux lourds ≤ 10 ppm
Organic Impurities Meets USP/EP requirements

Ordering & Supply

  • Conditionnement : 25 kg fiber drum with double polyethylene bags; custom packaging available.
  • MOQ: 1 kg for pilot batches; 25 kg for commercial orders.
  • Délai de livraison: 3 à 5 jours ouvrés (articles en stock)
  • Documentation : COA, MSDS, TDS, and regulatory support provided.

Demande de devis

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