Amlodipine API (IP, BP, JP)

Amlodipine is a long-acting calcium channel blocker (CCB) belonging to the dihydropyridine class, used primarily in the treatment of high blood pressure (hypertension) and chest pain (angina). It works by relaxing blood vessels and improving blood flow, reducing the workload on the heart.

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Description

Amlodipine works by inhibiting the influx of calcium ions into vascular smooth muscle and cardiac muscle. This leads to vasodilation, reduced peripheral resistance, and subsequently lower blood pressure.

  • IUPAC Name: 3-Ethyl 5-methyl 2-[(2-aminoethoxy)methyl]-4-(2-chlorophenyl)-6-methyl-1,4-dihydropyridine-3,5-dicarboxylate
  • Molecular Formula: C20H25ClN2O5
  • Molecular Weight: 408.88 g/mol
  • Therapeutic Class: Calcium channel blocker (dihydropyridine class)
  • Usage: Primarily used to treat hypertension (high blood pressure) and angina (chest pain).
  • Appearance: White to off-white crystalline powder
  • Solubility: Sparingly soluble in water; soluble in methanol and ethanol
  • Melting Point: 199–201°C
  • Optical Rotation: Slightly optically active (due to chirality in the molecule)
  • Stability: Stable under recommended storage conditions (cool, dry place, protected from light)
  • Packaging and Storage:
    • Packaging: HDPE drums or fiber drums with double PE liners

    • Standard Pack Sizes: 5kg / 10 kg/ 25kg

    • Storage Conditions: Store below 25°C, in a dry place, away from light and moisture