Fenofibrate EP Impurity C CAS 217636-47-0
| CAS No. | 217636-47-0 |
| Molecular Formula | C17H15ClO3 |
| Molecular Weight | 302.75 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Fenofibrate EP Impurity C 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.
As a process- or degradation-related impurity, Fenofibrate EP Impurity C (CAS 217636-47-0, C17H15ClO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Fenofibrate EP Impurity C (C17H15ClO3) contains a steroid core, a hydroxyl group, an ether linkage, chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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.
Physical & Chemical Properties
| Molecular Formula | C17H15ClO3 |
| Molecular Weight | 302.75 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2019 |
| Halogen Content | Cl-containing |
Related Fenofibrate Standards
- Fenofibrate Impurity 12 (CAS 61002-27-5)
- Fenofibrate Impurity 16 (CAS CATO-C4X-164316)
- Fenofibrate Impurity 17 (CAS CATO-C4X-164317)
- Fenofibrate Impurity N113 (CAS 60012-96-6)
- Fenofibrate Impurity 2 (CAS 62809-66-9)
- Fenofibrate Impurity 13 (CAS CATO-C4X-164313)
- Fenofibrate Impurity N4 (CAS 66938-32-7)
- Fenofibrate EP Impurity B-d6 (Fenofibric Acid-d6) (CAS 1092484-69-9)
Recommended Standards
- Windorphen (CAS 19881-70-0)
- Empagliflozin Impurity 154 (CAS 2452301-22-1)
- Methyl 2-(3-chlorophenyl)-4-oxo-4-phenylbutanoate (CAS 344280-08-6)
- Erlotinib Impurity 62 (CAS CATO-C4X-106962)
- Afoxolaner Impurity 31 (CAS CATO-C4X-313731)
- Flunarizine Impurity 17 (CAS 17730-78-8)
- Glycyrrhizic Acid Impurity 19 (CAS CATO-C4X-253719)
- 5-((Trimethylsilyl)ethynyl)quinoline (CAS 1255952-63-6)
- tert-Butyl (4-aminophenyl)(ethyl)carbamate (CAS 885057-41-0)
- 2-Chloro-6-((4,6-dimethoxypyrimidin-2-yl)thio)benzoic acid (CAS 123342-93-8)
- 1-(dimethylamino)cyclobutane-1-carboxylic acid (CAS 1248314-84-2)
- Methyl({[1-methyl-3-(trifluoromethyl)-1h-pyrazol-4-yl]methyl})amine hydrochloride (CAS 1423024-17-2)
- [6-(morpholin-4-yl)pyridin-2-yl]methanamine (CAS 868755-52-6)
- Fibrinogen Related Peptide (CAS 80755-86-8)
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