Escitalopram API Manufacturer & Supplier in India

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

Escitalopram API Manufacturer & Supplier in India

Escitalopram is a selective serotonin reuptake inhibitor (SSRI) and the therapeutically active S-enantiomer of citalopram. It is an active pharmaceutical ingredient used in medicines for the treatment of major depressive disorder and generalized anxiety disorder.

Escitalopram selectively inhibits the serotonin transporter (SERT), reducing the reuptake of serotonin into presynaptic neurons and increasing serotonergic activity in the central nervous system.

What is Escitalopram?

Escitalopram is a synthetic small-molecule antidepressant belonging to the SSRI class. It is the S-enantiomer of citalopram and is commonly supplied as escitalopram oxalate in pharmaceutical products.

The molecular formula of Escitalopram is C₂₀H₂₁FN₂O₂, with a molecular weight of approximately 324.39 g/mol. The CAS Registry Number is 128196-01-0.

Mechanism of Action

Escitalopram selectively inhibits the serotonin transporter (SERT), preventing the reuptake of serotonin from the synaptic cleft.

This results in:

  • Increased serotonin availability
  • Enhanced serotonergic neurotransmission
  • Modulation of mood-related neural pathways
  • Antidepressant and anxiolytic effects

Pharmaceutical Applications

Escitalopram is primarily used in pharmaceutical formulations for:

  • Major depressive disorder
  • Generalized anxiety disorder
  • SSRI-based antidepressant formulations
  • Pharmaceutical research involving serotonergic pathways

The exact approved indications depend on the applicable regulatory product labeling.

Escitalopram API

Escitalopram is a small-molecule pharmaceutical API belonging to the SSRI antidepressant class. For commercial pharmaceutical products, it is frequently formulated as escitalopram oxalate.

Pharmaceutical-grade Escitalopram is evaluated for identity, assay, related substances, residual solvents, water content and other applicable quality parameters.

Quality & Regulatory Considerations

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

Typical quality-control parameters include:

  • Identification
  • Assay
  • Related substances
  • Enantiomeric purity
  • Water content
  • Residual solvents
  • Residue on ignition
  • Elemental impurities
  • Physical characteristics

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

Storage

Escitalopram 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) NLT 98.0% by HPLC
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%
Melting Point 150°C – 154°C
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