Esaxerenone API Manufacturer & Supplier in India

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Esaxerenone API Manufacturer & Supplier in India

Esaxerenone is a synthetic, non-steroidal mineralocorticoid receptor (MR) antagonist used as an active pharmaceutical ingredient in medicines for cardiovascular and renal conditions. It selectively inhibits the mineralocorticoid receptor and reduces the effects of excessive aldosterone signaling.

Esaxerenone is a small-molecule pharmaceutical compound developed as a selective mineralocorticoid receptor blocker. It is primarily associated with the management of hypertension, particularly in patients with diabetic kidney disease in applicable clinical settings.

What is Esaxerenone?

Esaxerenone is a non-steroidal mineralocorticoid receptor antagonist. Unlike steroidal MR antagonists, it has a non-steroidal chemical structure and is designed to selectively inhibit mineralocorticoid receptor activity.

The molecular formula of Esaxerenone is C₂₂H₂₁ClF₂N₄O₃, with a molecular weight of approximately 462.88 g/mol. The CAS Registry Number is 1636800-77-7.

Mechanism of Action

Esaxerenone selectively binds to and antagonizes the mineralocorticoid receptor (MR).

By blocking aldosterone-mediated MR activation, Esaxerenone can reduce:

  • Sodium reabsorption
  • Aldosterone-mediated fluid retention
  • Mineralocorticoid receptor signaling
  • Cardiovascular and renal effects associated with excessive aldosterone activity

Pharmaceutical Applications

Esaxerenone is primarily associated with:

  • Hypertension
  • Mineralocorticoid receptor antagonist therapy
  • Cardiovascular pharmaceutical research
  • Renal-protective therapeutic research
  • Diabetic kidney disease-related applications in applicable markets

Esaxerenone API

Esaxerenone is a small-molecule pharmaceutical API belonging to the non-steroidal mineralocorticoid receptor antagonist class.

Pharmaceutical-grade Esaxerenone is evaluated using analytical procedures appropriate for identity, assay, related substances, residual solvents, water content and other applicable quality attributes.

Quality & Regulatory Considerations

Esaxerenone API intended for pharmaceutical manufacturing should comply with the applicable approved specification and regulatory requirements.

Typical quality-control parameters include:

  • Identification
  • Assay
  • Related substances
  • Water content
  • Residual solvents
  • Elemental impurities
  • Residue on ignition, where applicable
  • Particle/physical characteristics where applicable

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

Storage

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

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR & HPLC compliant
Assay (HPLC) NLT 98.0% by HPLC
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 20 ppm
pH (1% Solution) 5.5 – 6.5
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Water Content NMT 1.0%
Melting Point 150°C – 154°C
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