Esmolol Hydrochloride API Manufacturer & Supplier in India

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Esmolol Hydrochloride API Manufacturer & Supplier in India

Esmolol Hydrochloride is a short-acting, cardioselective beta-1 adrenergic receptor blocker used as an active pharmaceutical ingredient in cardiovascular medicines. Its rapid onset and short duration of action make it suitable for situations where temporary and precisely controlled beta-blockade is required.

Esmolol Hydrochloride is the hydrochloride salt of esmolol and is primarily used in intravenous pharmaceutical formulations for short-term control of heart rate and certain cardiovascular conditions.

What is Esmolol Hydrochloride?

Esmolol Hydrochloride is a synthetic ultra-short-acting beta-adrenergic blocker with preferential activity at beta-1 receptors in cardiac tissue.

CAS Number: 81147-84-2
Molecular Formula: C₁₆H₂₆ClNO₄
Molecular Weight: 331.84 g/mol

Mechanism of Action

Esmolol Hydrochloride competitively blocks beta-1 adrenergic receptors, reducing the effects of catecholamines on the heart.

This produces:

  • Reduction in heart rate
  • Reduction in myocardial contractility
  • Slowing of cardiac conduction
  • Reduction in myocardial oxygen demand
  • Rapidly titratable beta-blockade

Esmolol is rapidly hydrolyzed by esterases in red blood cells, contributing to its very short duration of action.

Pharmaceutical Applications

Esmolol Hydrochloride is used in pharmaceutical formulations for:

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

The exact approved indications depend on the applicable regulatory labeling.

Esmolol Hydrochloride API

Esmolol Hydrochloride is a small-molecule cardiovascular API belonging to the beta-blocker class. It is particularly suited to injectable pharmaceutical formulations requiring rapid onset and rapid adjustment of beta-adrenergic blockade.

Quality testing generally includes identification, assay, related substances, water content, residual solvents and other applicable physicochemical parameters.

Quality & Regulatory Considerations

Pharmaceutical-grade Esmolol Hydrochloride 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
  • 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 Hydrochloride 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 10 ppm
pH (1% Solution) 5.5 – 6.5
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
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