Flufenamic Acid API Manufacturer in India

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

Flufenamic Acid API Manufacturer in India

Flufenamic Acid API is an anthranilic acid derivative belonging to the fenamate class of non-steroidal anti-inflammatory compounds. Flufenamic Acid has the chemical formula C₁₄H₁₀F₃NO₂, molecular weight 281.23 g/mol, and CAS Number 530-78-9.

Flufenamic Acid is identified chemically as 2-[3-(trifluoromethyl)anilino]benzoic acid. It is supplied as a crystalline solid and commercial analytical-grade specifications commonly report HPLC purity of ≥98.0%. TCI specifies a minimum HPLC purity of 98.0 area% and a melting-point range of 133–137°C.

Flufenamic Acid Chemical Properties

Flufenamic Acid is a crystalline solid with a molecular weight of 281.23 g/mol. Reported melting-point values are approximately 132–137°C, depending on the reference and material specification. It is practically insoluble in water and is soluble in organic solvents including methanol, ethanol, DMSO and DMF.

Flufenamic Acid API Applications

Flufenamic Acid is used as an active pharmaceutical ingredient and as a reference compound in pharmaceutical and analytical research. It belongs to the fenamate/anthranilic acid derivative class of NSAIDs.

Quality and Documentation

For commercial API supply, the applicable specification should be established against the manufacturer's approved specification and batch-specific Certificate of Analysis (CoA). Analytical testing may include identification, HPLC assay, impurity profiling and other quality-control parameters applicable to the intended grade and regulatory market.

Detailed Specifications

Parameter Specification
Appearance White to off-white crystalline powder
Identification IR / HPLC / NMR conforms to structure
Assay (HPLC) NLT 98.0%
Loss on Drying NMT 1.0%
Residue on Ignition NMT 0.5%
Heavy Metals NMT 20 ppm
pH (1% Solution) 2.0 – 4.0
Individual Impurity NMT 0.5%
Total Impurities NMT 1.0%
Melting Point 133–137°C
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