Fenofibrate Impurity N4 CAS 66938-32-7
| CAS No. | 66938-32-7 |
| Molecular Formula | C14H10Cl2O2 |
| Molecular Weight | 281.13 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
Fenofibrate Impurity N4 (CAS 66938-32-7) is a certified pharmaceutical impurity reference standard with the molecular formula C14H10Cl2O2 and a molecular weight of 281.13 g/mol.
Owing to a carboxylic acid group, a hydroxyl group, an ether linkage, chlorine substitution, a polycyclic aromatic system, Fenofibrate Impurity N4 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 281.13 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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 | C14H10Cl2O2 |
| Molecular Weight | 281.13 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in chloroform, dichloromethane, ethyl acetate, DMSO |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1976 |
| Halogen Content | Cl-containing |
Related Fenofibrate Standards
- Fenofibrate Impurity 13 (CAS CATO-C4X-164313)
- Fenofibrate EP Impurity F (CAS 154356-96-4)
- Fenofibrate Impurity 16 (CAS CATO-C4X-164316)
- Fenofibrate Impurity 14 (CAS 60013-02-7)
- Fenofibrate Impurity 15 (CAS 34183-01-2)
- Fenofibrate Impurity 12 (CAS 61002-27-5)
- Fenofibrate EP Impurity C (CAS 217636-47-0)
- Fenofibrate Impurity 19 (CAS 10547-60-1)
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- CAS 1333112-32-5 (CAS 1333112-32-5)
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