| CAS No. | 204589-58-2 |
| Molecular Formula | C24H21F2NO2 |
| Molecular Weight | 393.43 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Compared with other compounds in its class, the molecular weight of 393.43 g/mol gives Ezetimibe Impurity 1 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
CATO supplies Ezetimibe Impurity 1 (CAS 204589-58-2), a pharmacopoeial impurity reference standard (molecular formula C24H21F2NO2, MW 393.43 g/mol) used for the identification and quantification of trace impurities in APIs.
Based on its molecular formula C24H21F2NO2, Ezetimibe Impurity 1 contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 393.43 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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 1 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.
| Molecular Formula | C24H21F2NO2 |
| Molecular Weight | 393.43 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| Storage | Store at 2-8°C, 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) | 14.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2015 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |