Esmolol API Manufacturer & Supplier in India

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Esmolol API Manufacturer & Supplier in India

Esmolol is a short-acting, cardioselective beta-1 adrenergic receptor blocker used as an active pharmaceutical ingredient in medicines for the rapid control of heart rate and certain cardiovascular conditions. Its very short duration of action makes it suitable when rapid titration of beta-blockade is required.

Esmolol is commonly supplied pharmaceutically as esmolol hydrochloride, a water-soluble hydrochloride salt used in intravenous formulations.

What is Esmolol?

Esmolol is a synthetic beta-adrenergic blocking agent belonging to the cardioselective beta-1 blocker class. It preferentially blocks beta-1 adrenergic receptors in cardiac tissue and reduces sympathetic stimulation of the heart.

The molecular formula of Esmolol is C₁₆H₂₅NO₄, with a molecular weight of approximately 295.38 g/mol. Esmolol hydrochloride has a molecular weight of approximately 331.84 g/mol.

CAS Number: 103598-03-4 for esmolol; 81147-84-2 for esmolol hydrochloride.

Mechanism of Action

Esmolol competitively blocks beta-1 adrenergic receptors, reducing the effects of catecholamines such as epinephrine and norepinephrine on the heart.

This produces:

  • Reduced heart rate
  • Reduced myocardial contractility
  • Reduced cardiac conduction
  • Reduced myocardial oxygen demand
  • Rapidly controllable beta-blockade

Esmolol has an exceptionally short duration of action because it is rapidly metabolized by esterases in red blood cells.

Pharmaceutical Applications

Esmolol is primarily used in pharmaceutical formulations for:

  • Rapid control of ventricular rate in atrial fibrillation or atrial flutter
  • Perioperative tachycardia and hypertension
  • Supraventricular tachycardia
  • Short-term heart-rate control
  • Situations requiring rapidly titratable beta-1 blockade

The exact approved indications depend on the applicable regulatory product labeling.

Esmolol API

Esmolol is a small-molecule cardiovascular API belonging to the beta-blocker class. Pharmaceutical products are generally formulated using esmolol hydrochloride for intravenous administration.

Quality evaluation may include identity, assay, related substances, water content, residual solvents, optical purity where applicable and other physicochemical parameters.

Quality & Regulatory Considerations

Pharmaceutical-grade Esmolol/Esmolol Hydrochloride intended for manufacturing should comply with the applicable approved specification and relevant pharmacopoeial and regulatory requirements.

Typical quality-control parameters include:

  • Identification
  • Assay
  • Related substances
  • Water content
  • Residual solvents
  • Residue on ignition
  • Enantiomeric/optical purity where applicable
  • Elemental impurities
  • Microbial quality where applicable

A qualified supplier should provide Certificate of Analysis (CoA), specification sheet, SDS/MSDS, batch traceability and applicable regulatory documentation.

Storage

Esmolol API should be stored in a tightly closed container, protected from excessive moisture, heat and direct light, according to the applicable approved storage and stability requirements.

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 20 ppm
pH (1% Solution) 2.0 – 4.0
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
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