Fleroxacin is a synthetic fluoroquinolone antibacterial compound belonging to the quinolone class of antimicrobial agents. It is chemically identified as 6,8-difluoro-1-(2-fluoroethyl)-7-(4-methylpiperazin-1-yl)-4-oxoquinoline-3-carboxylic acid. Fleroxacin has the molecular formula C17H18F3N3O3 and a molecular weight of 369.34 g/mol. Its CAS Registry Number is 79660-72-3.
Fleroxacin acts as a fluoroquinolone antibacterial agent and is associated with inhibition of bacterial DNA gyrase and topoisomerase IV, enzymes required for bacterial DNA replication and maintenance.
Fleroxacin API is used as an active pharmaceutical ingredient for pharmaceutical research and formulation applications involving fluoroquinolone antibacterial compounds. It is generally described as a crystalline solid or powder with a white to off-white appearance. Commercial analytical references report purity values of ≥98% by HPLC.
Fleroxacin is a fluoroquinolone antibacterial compound with activity against a range of Gram-positive and Gram-negative bacteria. Its antibacterial activity is associated with interference with bacterial DNA replication through inhibition of DNA gyrase and topoisomerase IV.
For pharmaceutical API applications, Fleroxacin should be handled according to applicable regulatory requirements, quality specifications and intended-use controls.
Fleroxacin inhibits bacterial enzymes involved in DNA replication, particularly DNA gyrase and topoisomerase IV. Inhibition of these enzymes interferes with bacterial DNA replication, transcription, repair and recombination, resulting in antibacterial activity.
Fleroxacin API can be considered for pharmaceutical development and analytical applications requiring a fluoroquinolone antibacterial active ingredient. API quality should be evaluated using appropriate identity, assay, impurity and physicochemical testing procedures.
Important quality documentation may include:
Published commercial specifications for Fleroxacin include ≥98% HPLC purity, while supplier information describes the material as a solid or powder with white to off-white appearance.
For pharmaceutical manufacturing, the final acceptance criteria should be based on the applicable approved specification and validated analytical method. FDA guidance recognizes specific identification procedures and stability-indicating assays as important elements of drug-substance specifications.
Fleroxacin should be stored in a tightly closed container under controlled conditions appropriate for the material and its approved specification. Published supplier information lists ambient storage for one research-grade product, while another supplier recommends storage at 4 °C; therefore, storage conditions should follow the specific manufacturer's approved documentation for the supplied grade.
Fleroxacin API may be packaged in suitable pharmaceutical or laboratory-grade containers according to the intended application, batch quantity and transportation requirements. Packaging should protect the material from contamination and unsuitable environmental exposure.
Fleroxacin provides a defined fluoroquinolone API profile with established chemical identification and publicly documented physicochemical characteristics. Reliable sourcing should focus on identity, purity, batch consistency, analytical documentation and compliance with the applicable quality requirements.
| Parameter | Specification |
|---|---|
| Appearance | White to off-white crystalline powder |
| Identification | IR & HPLC compliant |
| Assay (HPLC) | ≥98.0% |
| Loss on Drying | NMT 1.0% |
| Residue on Ignition | NMT 0.5% |
| Heavy Metals | NMT 20 ppm |
| pH (1% Solution) | 2.0 – 4.0 |
| Melting Point | 264–266 °C |