Etilefrine API Manufacturer & Supplier in India

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Etilefrine API Manufacturer & Supplier in India

Etilefrine is a synthetic sympathomimetic agent and active pharmaceutical ingredient (API) with predominantly α-adrenergic activity. It is used as a vasopressor to increase vascular tone and blood pressure in certain forms of hypotension.

Etilefrine acts primarily by stimulating adrenergic receptors, resulting in increased vascular resistance and cardiovascular effects.

What is Etilefrine?

Etilefrine is a phenethylamine derivative with direct and indirect sympathomimetic properties. It is commonly encountered as Etilefrine Hydrochloride in pharmaceutical formulations.

CAS Number: 709-98-8
Molecular Formula: C₁₀H₁₅NO₂
Molecular Weight: 181.23 g/mol

Mechanism of Action

Etilefrine stimulates adrenergic receptors, particularly α-adrenergic receptors, leading to vasoconstriction and increased vascular tone.

Its pharmacological effects include:

  • α-adrenergic receptor stimulation
  • Increased peripheral vascular resistance
  • Increased blood pressure
  • Cardiovascular stimulation
  • Improvement of vascular tone in certain hypotensive conditions

Pharmaceutical Applications

Etilefrine is used in pharmaceutical formulations for:

  • Hypotension
  • Orthostatic hypotension
  • Low blood pressure associated with impaired vascular tone
  • Other clinically appropriate hypotensive conditions according to approved labeling

The exact therapeutic application depends on the formulation, country and applicable regulatory labeling.

Etilefrine API

Etilefrine is a sympathomimetic pharmaceutical ingredient with defined chemical and physicochemical 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
  • Optical rotation, where applicable
  • Melting point
  • Particle-size characteristics, where applicable

Quality & Regulatory Considerations

Pharmaceutical-grade Etilefrine should comply with the applicable approved specification, pharmacopoeial requirements where applicable, and relevant regulatory standards.

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

Storage

Store Etilefrine 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 Conforms to USP identification tests
Assay (HPLC) 98.0% – 102.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 10 ppm
Individual Impurity ≤ 0.5%
Total Impurities NMT 2.0%
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