Ebastine EP Impurity E CAS 1312211-93-0
| CAS No. | 1312211-93-0 |
| Molecular Formula | C33H41NO2 |
| Molecular Weight | 483.68 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Compared with other compounds in its class, the molecular weight of 483.68 g/mol gives Ebastine EP Impurity E distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
CATO supplies Ebastine EP Impurity E (CAS 1312211-93-0), a pharmacopoeial impurity reference standard (molecular formula C33H41NO2, MW 483.68 g/mol) used for the identification and quantification of trace impurities in APIs.
Ebastine EP Impurity E (C33H41NO2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. Its high carbon-to-hydrogen ratio confers good lipid solubility, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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), Ebastine EP Impurity E 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 | C33H41NO2 |
| Molecular Weight | 483.68 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >95% |
| 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 |
| Degree of Unsaturation (DBE) | 14.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1990 |
| Nitrogen Atoms | 1 |
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