Ethacrynic Acid API Manufacturer & Supplier in India

Swapnroop Pharma · WHO-GMP Certified · +91 87670 62101

Ethacrynic Acid API Manufacturer & Supplier in India

Ethacrynic Acid is a potent loop diuretic and an active pharmaceutical ingredient (API) used in pharmaceutical formulations for the management of edema associated with various medical conditions. It acts primarily on the Na⁺-K⁺-2Cl⁻ cotransporter (NKCC2) in the thick ascending limb of the loop of Henle, increasing the excretion of sodium, chloride and water.

Ethacrynic Acid is a non-sulfonamide loop diuretic, making it chemically distinct from several other commonly used loop diuretics.

What is Ethacrynic Acid?

Ethacrynic Acid is a phenoxyacetic acid derivative with potent diuretic activity. It inhibits electrolyte reabsorption in the renal tubules and produces a rapid increase in urine formation.

CAS Number: 58-54-8
Molecular Formula: C₁₃H₁₂Cl₂O₄
Molecular Weight: 303.14 g/mol

Mechanism of Action

Ethacrynic Acid inhibits the Na⁺-K⁺-2Cl⁻ cotransporter (NKCC2) in the thick ascending limb of the loop of Henle.

This results in:

  • Increased sodium excretion
  • Increased chloride excretion
  • Increased potassium and water excretion
  • Increased urine output
  • Reduction of extracellular fluid volume
  • Reduction of edema

Ethacrynic Acid is also known for its non-sulfonamide chemical structure.

Pharmaceutical Applications

Ethacrynic Acid is used in pharmaceutical formulations for:

  • Edema associated with congestive heart failure
  • Edema associated with renal disorders
  • Edema associated with hepatic disorders
  • Fluid retention requiring loop-diuretic therapy
  • Other clinically appropriate fluid-overload conditions

The exact indication depends on the final pharmaceutical formulation and applicable regulatory labeling.

Ethacrynic Acid API

Ethacrynic Acid is a loop diuretic API with defined chemical and physical characteristics. Pharmaceutical-grade material requires appropriate control of identity, assay, related substances and other quality attributes.

Typical quality evaluation may include:

  • Identification
  • Assay
  • Related substances
  • Water content
  • Residual solvents
  • Elemental impurities
  • Particle-size characteristics, where applicable
  • Other applicable pharmacopoeial tests

Quality & Regulatory Considerations

Pharmaceutical-grade Ethacrynic Acid should comply with the applicable approved specification and relevant pharmacopoeial and regulatory requirements.

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

Storage

Store Ethacrynic Acid in a tightly closed container, protected from excessive moisture, heat and direct light, according to the manufacturer's 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
Water Content NMT 1.0%
Melting Point 150°C – 154°C
Get Bulk Quote via WhatsApp