Isradipine API | Calcium Channel Blocker API Manufacturer in India

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Isradipine API

Isradipine is a dihydropyridine calcium channel blocker (CCB) used primarily as an antihypertensive agent. It selectively inhibits L-type calcium channels in vascular smooth muscle, producing arterial vasodilation and a reduction in peripheral vascular resistance.

Isradipine is administered orally and is primarily associated with the treatment of hypertension.

Isradipine API Manufacturer in India

Isradipine is a specialized cardiovascular pharmaceutical API manufactured through controlled chemical synthesis, purification and crystallization.

Important quality attributes include identity, assay, related substances, water content, residual solvents, elemental impurities, dissolution-related properties and stability.

Chemical Information

CAS Number: 75695-93-1
Molecular Formula: C23H21N3O5
Molecular Weight: 419.44 g/mol
Drug Class: Calcium Channel Blocker
Pharmacological Class: Dihydropyridine Calcium Channel Blocker
Therapeutic Class: Antihypertensive
Therapeutic Area: Cardiology

Mechanism of Action

Isradipine inhibits the influx of calcium ions through L-type voltage-dependent calcium channels, particularly in vascular smooth muscle.

This produces:

  • Arterial vasodilation
  • Reduced systemic vascular resistance
  • Reduced blood pressure
  • Increased coronary blood flow

Its vascular selectivity is responsible for its principal antihypertensive effect.

Pharmaceutical Applications

Isradipine is primarily used for:

  • Hypertension
  • Blood-pressure control
  • Cardiovascular pharmacology research
  • Calcium-channel blocker formulation development

Its approved indications can vary according to the regulatory jurisdiction and formulation.

Dihydropyridine Characteristics

Isradipine belongs to the 1,4-dihydropyridine class of calcium channel blockers. Like other members of this class, its principal pharmacological effect is relaxation of arterial vascular smooth muscle.

The reduction in peripheral vascular resistance contributes to its antihypertensive activity.

Manufacturing Process

Typical API manufacturing may involve:

  1. Preparation of substituted aromatic intermediates
  2. Controlled chemical synthesis
  3. Formation of the dihydropyridine structure
  4. Purification
  5. Crystallization
  6. Filtration
  7. Drying
  8. Milling where required
  9. Final analytical testing
  10. Controlled packaging

Quality and Analytical Testing

Isradipine API quality evaluation may include:

  • Identification by IR
  • Identification by HPLC
  • Assay
  • Related substances
  • Organic impurities
  • Water content
  • Residual solvents
  • Elemental impurities
  • Residue on ignition
  • Melting range
  • Particle-size distribution where required
  • Polymorphic characterization
  • Stability testing

Storage

Isradipine should be stored in a tightly closed container under controlled pharmaceutical conditions, protected from excessive heat, moisture and direct light. Final storage conditions should be established from validated stability studies.

Pharmaceutical Research and Development

Isradipine is relevant to research involving:

  • Calcium channel blockers
  • L-type calcium channels
  • Dihydropyridine pharmacology
  • Hypertension
  • Cardiovascular drug development
  • Vascular smooth-muscle pharmacology
  • Antihypertensive formulations

Isradipine API Summary

Isradipine is a dihydropyridine L-type calcium channel blocker with CAS Number 75695-93-1, molecular formula C23H21N3O5, and molecular weight 419.44 g/mol. It produces arterial vasodilation by inhibiting L-type calcium channels and is primarily used as an antihypertensive agent.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 10 ppm
pH (1% Solution) 4.0 – 7.0
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
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