Isoproterenol HCl API | Isoproterenol Hydrochloride API Manufacturer in India

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Isoproterenol HCl API

Isoproterenol Hydrochloride (Isoproterenol HCl) is a synthetic sympathomimetic amine and non-selective beta-adrenergic receptor agonist. It produces pronounced stimulation of β₁ and β₂ adrenergic receptors, resulting in increased cardiac activity and relaxation of bronchial smooth muscle.

It is primarily used as a cardiovascular agent in controlled clinical settings and may be administered as an intravenous infusion or by other parenteral routes depending on the approved formulation.

Isoproterenol HCl API Manufacturer in India

Isoproterenol HCl is a specialized adrenergic pharmaceutical API manufactured through controlled chemical synthesis, purification and salt formation.

Critical quality attributes include identity, assay, related substances, water content, residual solvents, optical purity where applicable, chloride content and stability.

Chemical Information

CAS Number: 51-30-9
Molecular Formula: C11H17NO3·HCl
Molecular Weight: 247.72 g/mol
Drug Class: Adrenergic Agonist
Pharmacological Class: Non-Selective Beta-Adrenergic Agonist
Therapeutic Class: Cardiovascular Agent
Therapeutic Area: Cardiology / Emergency Medicine

Mechanism of Action

Isoproterenol stimulates β₁- and β₂-adrenergic receptors.

β₁-receptor stimulation increases cardiac:

  • Heart rate
  • Myocardial contractility
  • Cardiac conduction

β₂-receptor stimulation promotes:

  • Bronchial smooth-muscle relaxation
  • Peripheral vasodilation

The overall pharmacological effect is therefore predominantly positive chronotropic and inotropic cardiac activity with bronchodilation.

Pharmaceutical Applications

Isoproterenol HCl has clinical applications in selected cardiovascular situations, including:

  • Symptomatic bradycardia in appropriate clinical settings
  • Certain types of heart block
  • Temporary cardiac stimulation
  • Management of selected arrhythmias under specialist supervision
  • Pharmacological cardiac stress/testing applications

Its use depends on the approved formulation and applicable clinical guidelines.

Adrenergic Pharmacology

Isoproterenol differs from selective β₁ agonists because it activates both β₁ and β₂ receptors. Its pharmacological activity can therefore produce substantial increases in heart rate and contractility while also causing peripheral vasodilation.

Manufacturing Process

Typical API manufacturing may involve:

  1. Preparation of the aromatic precursor
  2. Controlled chemical synthesis
  3. Introduction of the amino-alcohol side chain
  4. Purification
  5. Formation of the hydrochloride salt
  6. Crystallization
  7. Filtration
  8. Drying
  9. Milling where required
  10. Final analytical testing
  11. Controlled packaging

Quality and Analytical Testing

Isoproterenol HCl API quality evaluation may include:

  • Identification by IR
  • Identification by HPLC
  • Assay
  • Related substances
  • Optical purity / stereochemical assessment
  • Water content
  • Chloride content
  • Residual solvents
  • Elemental impurities
  • Residue on ignition
  • pH
  • Particle-size distribution where required
  • Stability testing

Storage

Isoproterenol HCl should be stored in a tightly closed container under controlled pharmaceutical conditions, protected from excessive heat, moisture and light. Because catechol-containing compounds can be susceptible to oxidation, appropriate environmental and packaging controls are important.

Pharmaceutical Research and Development

Isoproterenol HCl is relevant to research involving:

  • β-adrenergic receptor pharmacology
  • Cardiovascular pharmacology
  • Sympathomimetic agents
  • Cardiac stimulation
  • Bronchodilation
  • Arrhythmia research
  • Adrenergic signaling
  • Pharmaceutical formulation development

Isoproterenol HCl API Summary

Isoproterenol HCl is a non-selective β-adrenergic receptor agonist with CAS Number 51-30-9, molecular formula C11H17NO3·HCl, and molecular weight 247.72 g/mol. It stimulates β₁ and β₂ receptors and is primarily associated with cardiovascular applications requiring controlled adrenergic stimulation.

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%
Individual Impurity ≤ 0.5%
Total Impurities ≤ 1.5%
Water Content NMT 2.0%
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