Etretinate API Manufacturer & Supplier in India

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Etretinate API Manufacturer & Supplier in India

Etretinate is a synthetic retinoid and active pharmaceutical ingredient (API) derived from vitamin A. It belongs to the first-generation retinoid class and has been used in the treatment of severe disorders of keratinization and certain forms of psoriasis.

Etretinate is a lipophilic retinoid and is metabolized to acitretin, another systemic retinoid with retinoid activity.

What is Etretinate?

Etretinate is an aromatic retinoid ester with activity on nuclear retinoid receptors. It influences cellular differentiation and proliferation in epithelial tissues and has historically been used as a systemic treatment for severe keratinization disorders.

CAS Number: 54350-48-0
Molecular Formula: C₂₃H₃₀O₃
Molecular Weight: 354.49 g/mol

Mechanism of Action

Etretinate and its active retinoid metabolites influence gene transcription through nuclear retinoid receptors, affecting epithelial cell differentiation and proliferation.

Its pharmacological effects include:

  • Modulation of retinoid receptor signaling
  • Regulation of epithelial cell differentiation
  • Influence on keratinocyte proliferation
  • Reduction of abnormal keratinization
  • Modulation of inflammatory and epidermal processes

Pharmaceutical Applications

Etretinate has historically been used for:

  • Severe psoriasis
  • Disorders of keratinization
  • Severe congenital ichthyosis
  • Other severe dermatological conditions associated with abnormal keratinization

Important: Etretinate has significant regulatory and safety restrictions and is not marketed in many countries. Its use should be considered only where specifically approved by the applicable regulatory authority.

Etretinate API

Etretinate is a lipophilic retinoid API with defined chemical and physicochemical characteristics. Pharmaceutical-grade material requires appropriate control of identity, assay, related substances, stereochemical composition and other quality attributes.

Typical quality evaluation may include:

  • Identification
  • Assay
  • Related substances
  • Isomeric purity
  • Water content
  • Residual solvents
  • Elemental impurities
  • Specific optical rotation, where applicable
  • Melting point
  • Particle-size characteristics, where applicable

Quality & Regulatory Considerations

Pharmaceutical-grade Etretinate should comply with the applicable approved specification and relevant regulatory requirements.

Because systemic retinoids can have important safety and reproductive risks, manufacture, distribution and use of Etretinate are subject to applicable regulatory controls.

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

Storage

Store Etretinate 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 0.2%
Heavy Metals NMT 10 ppm
pH (1% Solution) 2.0 – 4.0
Individual Impurity ≤ 0.5%
Total Impurities ≤ 1.5%
Water Content NMT 0.5%
Melting Point 150°C – 154°C
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