A-Fluralaner (CAS 1215216-63-9) – Chemical Properties & Introduction
Category Description
IUPAC Name：4-[5-(3,5-Dichlorophenyl)-5-(trifluoromethyl)-4H-1,2-oxazol-3-yl]-N-[2-oxo-2-(2,2,2-trifluoroethylamino)ethyl]-1-naphthalenecarboxamide
Molecular Formula:C₂₉H₁₄Cl₂F₆N₃O₃
Molecular Weight:640.34 g/mol
CAS Number:1207041-44-3
Appearance:White to pale yellow crystalline powder
Solubility:Insoluble in water; soluble in DMSO, ethanol, and acetone
Melting Point:150–155°C
Chemical Class:Isoxazoline derivative
Mechanism of Action:GABA/glutamate-gated chloride channel inhibitor (arthropod-specific)
Primary Use:Veterinary ectoparasiticide (fleas, ticks, mites)
Target Animals:Dogs and cats (oral or topical administration)
Regulatory Approvals:FDA (USA), EMA (EU), VICH guidelines
Key Benefits:Long-lasting protection (up to 12 weeks), broad-spectrum efficacy, low mammalian toxicity
| Parameter | Specification | Test Method | Acceptance Criteria |
|---|
| 1. Physical Properties |
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| Appearance | White to pale yellow crystalline powder | Visual inspection | Complies with reference standard |
| Solubility | Insoluble in water; Soluble in DMSO, ethanol | Solubility test (USP) | Clear solution at 10 mg/mL |
| 2. Chemical Identification |
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|
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| HPLC Retention Time | Matches reference standard (±5%) | Reverse-phase HPLC (C18 column) | RT 8.2±0.5 minutes |
| IR Spectrum | Consistent with reference | FT-IR spectroscopy | Major peaks matched |
| 3. Purity & Impurities |
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|
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| Assay (HPLC) | ≥ 98.0% | HPLC (UV 254 nm) | 98.0-102.0% |
| Total Impurities | ≤ 2.0% | HPLC area normalization | NMT 2.0% |
| Any Single Impurity | ≤ 0.5% | HPLC | NMT 0.5% |
| 4. Residual Content |
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|
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| Water Content | ≤ 0.5% w/w | Karl Fischer titration | NMT 0.5% |
| Residual Solvents | MeOH < 3000 ppm; DMSO < 500 ppm | GC-FID | ICH Q3C Class 2 limits |
| Heavy Metals | ≤ 10 ppm (as Pb) | ICP-MS | USP <231> |
| 5. Microbial Control |
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| Total Aerobic Count | ≤ 1000 CFU/g | USP <61> | Complies |
| Yeast/Mold | ≤ 100 CFU/g | USP <61> | Complies |
| Pathogens | Negative | USP <62> | Absent |
| 6. Packaging & Storage |
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| Packaging | Double PE bag + aluminum foil drum | Visual | Sealed, moisture-proof |
| Storage Conditions | 2-8°C, protected from light | Label verification | Controlled environment |
China
