Ezetimibe Impurity 91 CAS 851860-29-2
| CAS No. | 851860-29-2 |
| Molecular Formula | C31H27F2NO3 |
| Molecular Weight | 499.55 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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 process- or degradation-related impurity, Ezetimibe Impurity 91 (CAS 851860-29-2, C31H27F2NO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C31H27F2NO3, Ezetimibe Impurity 91 contains a nitrogen-containing heterocyclic scaffold, 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 499.55 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).
As a certified reference material (CRM), Ezetimibe Impurity 91 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 | C31H27F2NO3 |
| Molecular Weight | 499.55 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, 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) | 18.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1987 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Ezetimibe Standards
- Ezetimibe Impurity 79 (CAS 1683564-73-9)
- Ezetimibe Impurity 10 (CAS CATO-C4X-109810)
- Ezetimibe Impurity 14(Intermediate Impurity) (CAS 163222-32-0)
- Ezetimibe Impurity 71 (CAS CATO-C4X-109871)
- Ezetimibe Impurity 9 (CAS 163380-15-2)
- Ezetimibe Impurity 133 (CAS CATO-C4X-1098133)
- Ezetimibe Impurity 12(Intermediate Isomer Impurity) (CAS CATO-C4X-109812)
- Ezetimibe Impurity 8 (CAS CATO-C4X-10988)
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