Niflumic Acid is a synthetic non-steroidal anti-inflammatory drug (NSAID) belonging to the fenamate class of anti-inflammatory compounds. It is chemically identified as 2-[[3-(trifluoromethyl)phenyl]amino]pyridine-3-carboxylic acid and is used as a pharmaceutical active ingredient in anti-inflammatory and analgesic applications.
Niflumic Acid has been investigated for its anti-inflammatory, analgesic and cyclooxygenase-inhibitory properties and is also used in biochemical and pharmacological research.
Niflumic Acid is an established pharmaceutical API relevant to anti-inflammatory drug development, pharmaceutical formulation research and analytical applications.
The BP 2025 / Ph. Eur. monograph specifies Niflumic Acid at 98.5% to 101.5% on the dried substance. The monograph also defines requirements for related substances, chlorides, phosphates, loss on drying and sulfated ash.
CAS Number: 4394-00-7
Molecular Formula: C₁₃H₉F₃N₂O₂
Molecular Weight: 282.22 g/mol
Chemical Name: 2-[[3-(Trifluoromethyl)phenyl]amino]pyridine-3-carboxylic acid
IUPAC Name: 2-{[3-(Trifluoromethyl)phenyl]amino}pyridine-3-carboxylic acid
Drug Class: Fenamate NSAID
Therapeutic Class: Non-Steroidal Anti-Inflammatory Drug
Therapeutic Area: Inflammation / Pain
Molecule Type: Synthetic Small Molecule
NIST confirms the CAS number, molecular formula and molecular weight of Niflumic Acid.
Niflumic Acid exhibits anti-inflammatory activity primarily through inhibition of cyclooxygenase-related prostaglandin synthesis.
Its pharmacological properties include:
Experimental data have also characterized Niflumic Acid as a relatively selective COX-2 inhibitor, although its pharmacological profile extends to several ion-channel systems in experimental research.
Niflumic Acid API is relevant to:
Niflumic Acid has historically been associated with pharmaceutical applications involving inflammatory and painful musculoskeletal conditions.
Its pharmacological activity is associated with inhibition of cyclooxygenase pathways and reduction of inflammatory mediator production.
Niflumic Acid has been investigated as an inhibitor of cyclooxygenase enzymes, particularly COX-2.
Research data from FUJIFILM Wako report IC₅₀ values of approximately 16 μM for human recombinant COX-1 and 0.1 μM for COX-2, demonstrating substantially greater experimental inhibition of COX-2 under those assay conditions.
The BP 2025 / Ph. Eur. monograph describes Niflumic Acid as a pale yellow, crystalline powder.
It is reported as:
The pharmacopoeial melting point is approximately 204°C.
According to the BP 2025 / Ph. Eur. monograph, Niflumic Acid is:
Practically insoluble in water; freely soluble in acetone; soluble in ethanol (96%) and methanol.
A controlled Niflumic Acid API manufacturing process may involve:
Typical Niflumic Acid API testing may include:
The BP 2025 / Ph. Eur. monograph specifically establishes tests for impurity A/B/C, chlorides, phosphates, loss on drying and sulfated ash.
Store Niflumic Acid API in a tightly closed container under controlled pharmaceutical storage conditions, protected from excessive moisture, heat and direct light.
Storage conditions for a commercial API should be established according to validated stability data and the applicable approved specification.
| Parameter | Specification |
|---|---|
| Appearance | White crystalline powder or crystals |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | 98.5% – 101.5% |
| Loss on Drying | NMT 0.3% |
| Residue on Ignition | NMT 0.1% |
| Individual Impurity | NMT 0.1% |
| Total Impurities | NMT 0.30% |
| Water Content | NMT 0.3% |
| Melting Point | About 204°C |