Fluralaner impurity 44 CAS 1655515-91-5
| CAS No. | 1655515-91-5 |
| Molecular Formula | C8H3BrClF3O |
| Molecular Weight | 287.46 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Fluralaner impurity 44.
As a process- or degradation-related impurity, Fluralaner impurity 44 (CAS 1655515-91-5, C8H3BrClF3O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Fluralaner impurity 44 (C8H3BrClF3O) is characterized by a hydroxyl group, an ether linkage, fluorine/chlorine/bromine substitution, an aromatic ring system. In reversed-phase chromatography, its retention is governed primarily by the polarity and ionization state of its functional groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
This reference standard supports related-substances testing and method development in line with ICH Q3A/Q3B guidance on impurity control, and is suitable for system suitability testing and forced-degradation studies.
The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.
Physical & Chemical Properties
| Molecular Formula | C8H3BrClF3O |
| Molecular Weight | 287.46 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at room temperature, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| Stability | May oxidize slowly on prolonged air exposure |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1993 |
| Halogen Content | F/Cl/Br-containing |
Related Fluralaner Standards
- Fluralaner Impurity 20 (CAS CATO-C4X-218020)
- Fluralaner Impurity 19 (CAS CATO-C4X-218019)
- Fluralaner impurity 45 (CAS CATO-C4X-218045)
- Fluralaner impurity 40 (CAS CATO-C4X-218040)
- Fluralaner Impurity 4 (mix TBC as stabilizer) (CAS 864725-22-4)
- Fluralaner Impurity 52 (CAS 1248658-92-5)
- Fluralaner Impurity 18 (CAS CATO-C4X-218018)
- Fluralaner Impurity 48 (CAS CATO-C4X-218048)
Recommended Standards
- 4-Bromo-3-(trifluoromethyl)benzoyl chloride (CAS 914636-26-3)
- (3aR,4R,6aS)-4-{[(tert-Butyldimethylsilyl)oxy]methyl}-2,2-dimethyl-hexahydro-[1,3]dioxolo[4,5-c]pyrrole (CAS 153172-31-7)
- 3-Bromo-5-(trifluoromethyl)benzoyl chloride (CAS 958258-15-6)
- ((Tert-butyldimethylsilyl)imino)(fluoromethyl)(phenyl)-λ6-sulfanone (CAS 825638-25-3)
- Milbemycin Oxime EP Impurity E (CAS 86691-97-6)
- Venlafaxine EP Impurity B HCl (CAS 2174001-92-2)
- Cefpirome Impurity 20 (CAS CATO-C4X-120720)
- 2-(3,5-Dibromo-4-((2,4-dichloroquinolin-6-yl)oxy)phenoxy)acetic acid (CAS 918945-91-2)
- (1S,2S)-2-(4-bromobenzoyl)cyclopentanecarboxylic acid (CAS 959123-24-1)
- Difluprednate Impurity 3 (CAS 1234557-20-0)
- methyl 1,3-dithiane-2-carboxylate (CAS 56579-84-1)
- (Methyl-d3)hydrazine Monosulfate (Methyl-d3)hydrazinium Sulfate 70609-01-7 MHS-d3 Methyl Hydrazine-d3 Sulfate NSC 3802-d3 (CAS 70609-01-7)
- 1-Aminonaphthalen-2-ol (CAS 2834-92-6)
- Semaglutide impurity 195 (CAS CATO-C4X-2226195)
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