F-Fluralaner - Chemical Properties & Introduction
Category Specification
IUPAC Name：(Not fully published - Typically a fluorinated derivative of Fluralaner)
Common Name：F-Fluralaner (or Fluorinated Fluralaner)
Molecular Formula：C₂₉H₁₄Cl₂F₇N₃O₃ (Predicted*, based on Fluralaner structure with added fluorine)
Molecular Weight：~658.33 g/mol (Calculated*)
CAS Number：1122021-93-5
Appearance：White to off-white crystalline powder
Solubility：Insoluble in water; soluble in organic solvents (DMSO, ethanol)
Melting Point：150-160°C (Estimated)
Chemical Class：Fluorinated Isoxazoline derivative
Mechanism of Action：GABA/glutamate-gated chloride channel inhibitor (Enhanced arthropod selectivity)
Primary Use：Veterinary ectoparasiticide (Fleas, ticks, mites - Improved efficacy)
Target Animals：Dogs, cats (Oral/topical formulations)
Regulatory Status：Under development (Non-commercialized as of 2024)
Advantages：Potential for longer duration & lower dosage vs. Fluralaner
Quality Control Specifications
| Parameter | Specification | Test Method |
|---|
| Purity (HPLC) | ≥ 97.0% (Developmental grade) | Reverse-phase HPLC |
| Fluorine Content | ≥ 99% isotopic purity | NMR/MS |
| Related Substances | Total impurities ≤ 3.0% | HPLC/LC-MS |
| Storage | -20°C (Protect from moisture) | Stability studies |
| Category | Parameter | Specification | Test Method | Notes |
|---|
| Identity | Appearance | White to off-white crystalline powder | Visual inspection |
|
| HPLC Retention Time | Matches reference standard (±2%) | RP-HPLC (C18 column) | UV detection: 254 nm |
| IR Spectrum | Consistent with reference | FT-IR | Major functional groups matched |
| Purity | Assay (HPLC) | ≥ 97.0% (developmental grade) | HPLC (area normalization) | Mobile phase: ACN/water |
| Total Impurities | ≤ 3.0% | HPLC |
|
| Single Unknown Impurity | ≤ 0.5% | HPLC/LC-MS |
|
| Fluorine Content | Isotopic Purity (¹⁹F) | ≥ 98.5% | ¹⁹F NMR/MS | Critical for fluorinated analogs |
| Residuals | Water Content | ≤ 0.5% w/w | Karl Fischer titration |
|
| Residual Solvents | MeOH < 3000 ppm; DMSO < 500 ppm | GC-FID | ICH Q3C limits |
| Heavy Metals | ≤ 10 ppm (as Pb) | ICP-MS | USP <231> |
| Microbial | Total Aerobic Count | ≤ 1000 CFU/g | USP <61> |
|
| Yeast/Mold | ≤ 100 CFU/g | USP <61> |
|
| Pathogens | Absent | USP <62> |
|
| Stability | Storage Conditions | -20°C, protected from light/moisture | Long-term stability studies | Developmental phase |
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