Flecainide EP Impurity D CAS 35480-52-5
| CAS No. | 35480-52-5 |
| Molecular Formula | C11H8F6O4 |
| Molecular Weight | 318.17 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Structurally, Flecainide EP Impurity D (C11H8F6O4) contains a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, an aromatic ring system. The molecule exhibits a degree of unsaturation (DBE) of 5.0, corresponding to approximately 5 ring(s) or double-bond equivalent(s). With a molecular weight of 318.17 g/mol, it falls into the moderately-high-molecular-weight range. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
As a process- or degradation-related impurity, Flecainide EP Impurity D (CAS 35480-52-5, C11H8F6O4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
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.
As a certified reference material (CRM), Flecainide EP Impurity D meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Physical & Chemical Properties
| Molecular Formula | C11H8F6O4 |
| Molecular Weight | 318.17 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| Storage | Store in a cool place (≤25°C), keep sealed and dry |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1967 |
| Halogen Content | F-containing |
Related Flecainide Standards
Recommended Standards
- Crisaborole lmpurity 95 (CAS CATO-C4X-202195)
- 4-(3,4-Dichlorophenoxy)benzenesulfonamide (CAS 1032507-37-1)
- Tert-butyl (S)-(3-bromo-6,7-dihydro-5H-pyrazolo[5,1-b][1,3]oxazin-6-yl)carbamate (CAS 2409128-69-2)
- 5-(Morpholine-4-carbonyl)pyridine-3-boronic acid, pinacol ester (CAS 1073371-92-2)
- Sulindac impurity 13 (CAS CATO-C4X-293013)
- Oryzanol Impurity 18 (CAS 1236211-55-4)
- Atrasentan Impurity 76 (CAS 1058551-13-5)
- N-[2-(Phenethyloxy)benzyl]-4-(3-phenylpropoxy)-aniline (CAS 1040686-93-8)
- 4-benzyl-3-chloro-5-phenyl-4H-1,2,4-triazole (CAS 1020043-28-0)
- 4-[4-[5-(Aminomethyl)-2-oxo-3-oxazolidinyl]-2-fluorophenyl]-1-piperazinecarboxylic acid tert-butyl ester (CAS 154590-42-8)
- 2-Chloro-3-cyclopropoxy-5-methoxypyridine (CAS 1243466-68-3)
- 4-(4-Chlorophenyl)-3-(nitromethyl)-5-(trifluoromethyl)-4H-1,2,4-triazole (CAS 338394-01-7)
- Oryzanol Impurity 16 (CAS 286011-30-1)
- Palmitoyl Tetrapeptide-7 (CAS 221227-05-0)
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