Ezetimibe Impurity 57 CAS CATO-C4X-109857
| CAS No. | CATO-C4X-109857 |
| Molecular Formula | C31H27F2NO2 |
| Molecular Weight | 483.55 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
CATO supplies Ezetimibe Impurity 57 (CAS CATO-C4X-109857), a pharmacopoeial impurity reference standard (molecular formula C31H27F2NO2, MW 483.55 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Ezetimibe Impurity 57 (C31H27F2NO2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 18.0, corresponding to approximately 18 ring(s) or double-bond equivalent(s). With a molecular weight of 483.55 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.
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 | C31H27F2NO2 |
| Molecular Weight | 483.55 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at room temperature, protect from light |
| 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) | 18.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Ezetimibe Standards
- Ezetimibe Impurity C115 (CAS 204589-96-8)
- Ezetimibe Impurity 64 (CAS CATO-C4X-109864)
- Ezetimibe Impurity 65 (CAS CATO-C4X-109865)
- Ezetimibe Impurity 6 (CAS CATO-C4X-10986)
- Ezetimibe Impurity 7 (CAS CATO-C4X-10987)
- Ezetimibe diacetate (CAS 163380-20-9)
- Ezetimibe Impurity 12(Intermediate Isomer Impurity) (CAS CATO-C4X-109812)
- Ezetimibe Impurity 8 (CAS CATO-C4X-10988)
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Why CATO?
- ISO 17034 accredited reference material producer (CNAS + ANAB dual accreditation)
- 130,000+ catalog items in stock, COA supplied with every batch
- Worldwide shipping with full export documentation (HS code guidance available)
- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com