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Mefenamic acid
1. Basic Information
Name: Mefenamic acid
Alias: 2-(2,3-Dimethylphenyl)aminobenzoic acid
CAS No.: 61-68-7
Molecular Formula: C15H15NO2
Molecular Weight: 241.29
Category: Nonsteroidal anti-inflammatory API, analgesic raw material, antipyretic pharmaceutical intermediate, pharmacopoeia reference standard
2. Physical and Chemical Properties
Physical Properties
- Appearance: White to pale yellow crystalline powder
- Odor: Slight characteristic odor
- Solubility: Soluble in ethanol, chloroform, dilute alkaline solution; slightly soluble in hot methanol; practically insoluble in water
- Melting Point: 230–232 °C (decomposes slightly)
- Predicted Density: 1.18 g/cm3
- Hygroscopy: Non-hygroscopic under sealed normal storage
- Aqueous property: Weakly acidic aromatic carboxylic acid; dissolves in alkali to form soluble mefenamate salt
Chemical Properties
- Molecular structure: Benzoic acid skeleton linked with 2,3-dimethylaniline via amino bridge, contains carboxyl and secondary aromatic amine structure
- Pharmacological characteristic: Inhibits cyclooxygenase (COX), reduces prostaglandin synthesis to relieve pain, inflammation and fever
- Salt formation & esterification: Carboxyl group reacts with alkalis to make soluble salts; esterifies with alcohols under acid catalysis
- Photostability: Light-sensitive; long-term illumination gradually turns yellow and generates related impurities
- Thermal stability: Stable below 200 °C; over melting point heating decomposes to release irritating organic fumes
- Compatibility: Compatible with weak acidic auxiliary materials; incompatible with strong alkali, heavy metal ions and strong oxidants
3. Main Application Fields
1. Anti-inflammatory Analgesic API (Core Application)
Raw material for oral tablets, capsules, suspensions; used for dysmenorrhea, rheumatoid arthritis, postoperative pain, fever relief
2. Pharmaceutical Compound Preparation Intermediate
Compound pain relief formulations combined with other antipyretic analgesics
3. Pharmacopoeia Reference Standard
HPLC reference substance for related substance inspection of mefenamic acid bulk drugs and preparations
4. Organic Synthetic Research Reagent
Model diphenylamine carboxylic acid substrate for aromatic amine derivative research
4. Quality Specification Table
| Test Item | Standard Specification |
| CAS Number | 61-68-7 |
| Molecular Formula | C15H15NO2 |
| Appearance | Uniform off-white crystalline powder without deep yellow discoloration |
| HPLC Assay | Pharma API Grade 98.5%–101.5%, Reference Standard ≥99.8% |
| Water Content (KF) | ≤0.50% |
| Single Unknown Impurity | ≤0.10% |
| Total Related Substances | ≤0.30% |
| Heavy Metals (Pb) | ≤10 ppm |
| Packaging | Light-proof aluminum foil vacuum bag; bulk 25kg PE lined sealed fiber drum |
| Storage Condition | Hermetically sealed cool dry warehouse below 25 °C, full light shielding, isolated from alkaline and oxidizing chemicals |
| Transportation Requirement | Stable pharmaceutical crystalline powder, general medical chemical transport standard, avoid damp and sunlight |
| Shelf Life | 36 months under intact sealed packaging |
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