Ketoprofen is a non-steroidal anti-inflammatory drug (NSAID) and active pharmaceutical ingredient used for the management of pain and inflammation. It belongs to the propionic-acid derivative class of NSAIDs and produces analgesic and anti-inflammatory effects primarily through inhibition of cyclooxygenase enzymes involved in prostaglandin synthesis.
Ketoprofen is a racemic compound and is chemically identified as (RS)-2-(3-benzoylphenyl)propanoic acid. It is supplied as a pharmaceutical-grade active ingredient for the manufacture of appropriate pharmaceutical formulations.
Ketoprofen has the molecular formula C₁₆H₁₄O₃, molecular weight 254.28 g/mol, and CAS Number 22071-15-4. It occurs as a white crystalline powder and is practically insoluble in water while being soluble in several organic solvents.
Ketoprofen inhibits cyclooxygenase enzymes, reducing the formation of prostaglandins and other inflammatory mediators. This results in analgesic and anti-inflammatory activity and helps reduce pain, swelling and inflammation.
Ketoprofen is used in pharmaceutical formulations for the management of pain and inflammatory conditions, including musculoskeletal and joint-related disorders, according to the applicable formulation, regulatory approval and prescribing information.
Ketoprofen API can be evaluated using validated analytical procedures for identification, assay, related substances, loss on drying, residual solvents and other applicable quality attributes. The Japanese Pharmacopoeia monograph describes Ketoprofen as a white crystalline powder and specifies an assay of not less than 98.5% on the dried basis.
Ketoprofen should be stored in a tightly closed pharmaceutical-grade container under appropriate controlled conditions and protected from excessive heat, moisture and direct light. The applicable manufacturer's specification should be followed.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.0% – 102.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 4.0 – 7.0 |
| Individual Impurity | NMT 0.5% |
| Total Impurities | ≤ 1.5% |
| Water Content | NMT 1.0% |