Ezetimibe Impurity 48 CAS 1185883-39-9
| CAS No. | 1185883-39-9 |
| Molecular Formula | C40H36F2N2O5 |
| Molecular Weight | 662.72 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Ezetimibe Impurity 48.
CATO supplies Ezetimibe Impurity 48 (CAS 1185883-39-9), a pharmacopoeial impurity reference standard (molecular formula C40H36F2N2O5, MW 662.72 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Ezetimibe Impurity 48 (C40H36F2N2O5) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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 48 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 | C40H36F2N2O5 |
| Molecular Weight | 662.72 g/mol |
| Purity | 97%+ |
| Storage | Store in a cool place (≤25°C), protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 23.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1989 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 2 |
Related Ezetimibe Standards
- Ezetimibe Phenoxy tert-Butyldiphenylsilyl Ether (CAS 1042722-66-6)
- Ezetimibe Hydroxy tert-Butyldiphenylsilyl Ether (CAS 1217748-67-8)
- Ezetimibe Impurity 84 (CAS CATO-C4X-109884)
- Ezetimibe Impurity 85 (CAS CATO-C4X-109885)
- Ezetimibe Impurity 77 (CAS CATO-C4X-109877)
- Ezetimibe Impurity 134 (CAS CATO-C4X-1098134)
- Ezetimibe Impurity 135 (CAS CATO-C4X-1098135)
- Ezetimibe Impurity 136 (CAS CATO-C4X-1098136)
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Why CATO?
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- Technical support: +86 18665070610 / Nicole.chen@cato-chem.com