Ezetimibe Impurity 42 CAS 189028-95-3
| CAS No. | 189028-95-3 |
| Molecular Formula | C20H20FNO4 |
| Molecular Weight | 357.38 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Ezetimibe Impurity 42 (CAS 189028-95-3, C20H20FNO4) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Ezetimibe Impurity 42 (C20H20FNO4) contains a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 11.0, corresponding to approximately 11 ring(s) or double-bond equivalent(s). With a molecular weight of 357.38 g/mol, it falls into the moderately-high-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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), Ezetimibe Impurity 42 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 | C20H20FNO4 |
| Molecular Weight | 357.38 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 methanol, acetonitrile, DMSO, water (slightly soluble) |
| 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) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2011 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Ezetimibe Standards
- Ezetimibe Impurity 125 (CAS 439080-96-3)
- Ezetimibe Impurity 139 (CAS CATO-C4X-1098139)
- Ezetimibe Impurity 24 (CAS 528565-93-7)
- Ezetimibe Impurity 25 (CAS 404874-94-8)
- Ezetimibe Impurity 26 (CAS 1612153-32-8)
- Ezetimibe Impurity 93 (CAS CATO-C4X-109893)
- Ezetimibe Impurity 36 (CAS 189028-93-1)
- Ezetimibe Impurity 38 (CAS 404874-93-7)
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