Finafloxacin is a synthetic fluoroquinolone antibacterial active pharmaceutical ingredient (API). It belongs to the quinolone class of antimicrobial agents and is chemically identified by the molecular formula C20H19FN4O4 and molecular weight 398.4 g/mol. Its CAS Number is 209342-40-5.
Finafloxacin is a stereochemically defined compound containing two chiral centers. The drug substance is described in FDA regulatory documentation as the (S,S)-finafloxacin form. It is reported as a white to yellow powder or crystals and is non-hygroscopic.
Finafloxacin is a fluoroquinolone antibacterial used in pharmaceutical development and formulation. The FDA-approved otic formulation, XTORO (finafloxacin otic suspension) 0.3%, is indicated for the treatment of acute otitis externa caused by susceptible strains of Pseudomonas aeruginosa and Staphylococcus aureus.
Finafloxacin exerts antibacterial activity through inhibition of bacterial DNA gyrase and topoisomerase IV, enzymes required for bacterial DNA replication and maintenance.
Finafloxacin API quality can be assessed using analytical methods including IR, HPLC and chiral HPLC. Identification, assay, related substances, water content, residual solvents and other quality attributes should be controlled according to the applicable approved specification and Certificate of Analysis (CoA).
Quality Note: Numerical acceptance limits for assay, impurities, water content, residual solvents and other QC parameters should be taken from the current approved specification or batch-specific CoA rather than using unsupported generic values.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | NLT 98.0% by HPLC |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.2% |
| Heavy Metals | NMT 10 ppm |
| pH (1% Solution) | 5.5 – 6.5 |
| Individual Impurity | ≤ 0.5% |
| Total Impurities | ≤ 1.5% |