Etofenamate
CAS: 30544-47-9
Category: NSAIDs
| Purity | Reagent Grade ≥95%, Standard Grade ≥98%, High-Purity Grade ≥99%, Pharmaceutical Grade ≥98.0–102.0% |
| Molecular Formula | C18H18F3NO4 |
| Molecular Weight | 369.34 |
| Appearance | Pale yellow viscous oil or low-melting solid |
| Packaging | 25 mg/glass vial, 100 mg/glass vial, 250 mg/glass vial, 1 g/glass vial, 5 g/glass vial, 25 g/HDPE bottle, 100 g/HDPE bottle, or 1 kg/aluminum foil bag |
| Testing Indicators | Appearance — Visual inspection (pale yellow viscous oil or low-melting solid); Melting point — Capillary method (~25°C, literature; mp 25°C, hzbp.cn); Boiling point — Distillation (bp0.001 130–135°C, literature; bp760 451.1±45.0°C, predicted); Density — Hydrometer (d25 1.233–1.317 g/cm³, literature; 1.3±0.1 g/cm³, predicted); Refractive index — Abbe refractometer (nD25 1.564, literature; 1.552, predicted); Purity — HPLC-UV or GC-FID (≥95–99.5%, C18 column for HPLC or non-polar column for GC, λ=220–286 nm); Related substances — HPLC or GC (impurity profiling including flufenamic acid (Imp.A EP), butyl flufenamate (Imp.B EP), N-phenyl-3-(trifluoromethyl)aniline (Imp.C EP), and other ester hydrolysis products); Assay — RP-HPLC or GC-FID (linearity validated, recovery 98.0–102.0%); Loss on drying — Gravimetric (≤0.5%); Residue on ignition — Gravimetric (≤0.1%); Heavy metals — Colorimetric/ICP-MS (≤20 ppm); Identification — FTIR (characteristic peaks: N–H (aniline) ~3300–3500 cm⁻¹, O–H (alcohol) ~3200–3400 cm⁻¹, aromatic C–H ~3000–3100 cm⁻¹, aliphatic C–H ~2850–2950 cm⁻¹, ester C=O ~1720–1740 cm⁻¹, aromatic C=C ~1600 cm⁻¹, C–F ~1100–1300 cm⁻¹, C–O–C ~1100–1250 cm⁻¹); UV spectrophotometry (λmax 286 nm in methanol, E1%1cm 423); ¹H NMR (CDCl₃: δ 3.50–4.20 ppm multiplet CH₂O (ethoxyethanol), δ 4.30 ppm triplet CH₂OC=O, δ 6.50–7.80 ppm multiplet aromatic protons, δ 8.20 ppm broad singlet N–H); ¹³C NMR (CDCl₃: δ 60–70 ppm CH₂O, δ 115–150 ppm aromatic carbons, δ 165 ppm ester C=O); Mass spectrometry — EI-MS (m/z 369 [M]⁺, m/z 244 [M–CF₃C₆H₄]⁺, m/z 196 [flufenamic acid]⁺); Water content — Karl Fischer titration (GB/T 6283/EP 2.5.12); pH — Not applicable (practically insoluble in water); Specific optical rotation — Not applicable (achiral compound); Solubility — DMSO (≥50 mg/mL), ethanol (≥120 mg/mL), practically insoluble in water. |
| Storage Notes | Store in a cool, dry, well-ventilated area at 2–8°C. Protect from light, moisture, and air. Keep container tightly sealed. Store at -20°C for long-term stability (up to 3 years); at 4°C for 2 years. Light-sensitive and thermolabile material; avoid prolonged exposure to light, heat, and humid conditions. The compound is a pale yellow viscous oil at room temperature (melting point ~25°C) and is thermolabile at 180°C. Store away from strong oxidizing agents and incompatible substances. Use inert atmosphere (nitrogen or argon) for long-term storage if available. |
| Lead Time | 10 days |
Etofenamate (INN, also known as TVX-485, WHR-5020, Bayrogel, Rheumon, or Traumon) is a non-steroidal anti-inflammatory drug (NSAID) of the fenamic acid class and a non-selective cyclooxygenase (COX) inhibitor. It functions by inhibiting both cyclooxygenase and esteroxidase, thereby reducing prostaglandin synthesis and other inflammatory mediators to exert anti-inflammatory, analgesic, antipyretic, and anti-rheumatic effects. It is particularly effective as a percutaneously active antiphlogistic agent for topical application. Used as a pharmaceutical intermediate and active pharmaceutical ingredient (API) for the development and quality control of topical gel, cream, and ointment formulations (e.g., Rheumon gel, Traumon Gel, Bayrogel). Approved for clinical use in the treatment of muscle and joint pain, osteoarthritis, arthritis, and other inflammatory conditions. Also employed in analytical method development, pharmacokinetic studies, forced degradation studies, and quality control applications. ATC code: M02AA06.