Esflurbiprofen API Manufacturer & Supplier in India

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Esflurbiprofen API Manufacturer & Supplier in India

Esflurbiprofen is a non-steroidal anti-inflammatory drug (NSAID) and the S-enantiomer of flurbiprofen. It belongs to the propionic acid derivative class of NSAIDs and produces analgesic and anti-inflammatory effects primarily through inhibition of cyclooxygenase (COX) enzymes.

Esflurbiprofen is used as an active pharmaceutical ingredient in formulations intended for the management of pain and inflammation. It is also used in ophthalmic pharmaceutical applications in certain markets.

What is Esflurbiprofen?

Esflurbiprofen is the pharmacologically active S-enantiomer of flurbiprofen. It inhibits prostaglandin synthesis by reducing cyclooxygenase-mediated conversion of arachidonic acid to prostaglandins.

The molecular formula of Esflurbiprofen is C₁₅H₁₃FO₂, with a molecular weight of approximately 244.26 g/mol. The CAS Registry Number is 51543-39-6.

Mechanism of Action

Esflurbiprofen inhibits cyclooxygenase (COX) enzymes, reducing the formation of prostaglandins involved in pain and inflammation.

This results in:

  • Reduced prostaglandin synthesis
  • Reduction of inflammatory responses
  • Analgesic activity
  • Anti-inflammatory activity

Pharmaceutical Applications

Esflurbiprofen is associated with pharmaceutical formulations for:

  • Pain management
  • Inflammatory conditions
  • Musculoskeletal pain
  • Analgesic formulations
  • Ophthalmic anti-inflammatory formulations, depending on the specific product and market

Esflurbiprofen API

Esflurbiprofen is a small-molecule NSAID API and the active S-enantiomer of flurbiprofen.

For pharmaceutical manufacturing, Esflurbiprofen is evaluated using analytical methods for identity, assay, stereochemical purity, related substances, residual solvents, water content and other applicable quality attributes.

Because Esflurbiprofen is a chiral API, control of enantiomeric purity is an important quality consideration.

Quality & Regulatory Considerations

Pharmaceutical-grade Esflurbiprofen intended for 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
  • Optical rotation, where applicable

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

Storage

Esflurbiprofen 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 20 ppm
pH (1% Solution) 5.5 – 6.5
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Melting Point 168°C – 172°C
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