Ebastine EP Impurity C HCl CAS 65214-86-0
| CAS No. | 65214-86-0 |
| Molecular Formula | C18H21NO |
| Molecular Weight | N/A |
| 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 Ebastine EP Impurity C HCl.
Ebastine EP Impurity C HCl (CAS 65214-86-0) is a certified pharmaceutical impurity reference standard with the molecular formula C18H21NOHCl and a molecular weight of 303.83 g/mol.
Ebastine EP Impurity C HCl (C18H21NOHCl) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. Halogen substitution raises its density and boiling point, its high carbon-to-hydrogen ratio confers good lipid solubility; 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.
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 | C18H21NO HCl |
| Molecular Weight | 303.83 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| 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 |
| Degree of Unsaturation (DBE) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1975 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Ebastine Standards
- Ebastine Impurity 11 (CAS 1229622-28-9)
- Ebastine N-Oxide (CAS 1256285-71-8)
- Ebastine EP Impurity E (CAS 1312211-93-0)
- Ebastine EP Impurity E Fumarate (CAS 1312211-93-0(Free Base))
- Ebastine EP Impurity F (CAS 1429071-63-5)
- Ebastine EP Impurity G (CAS 1429071-65-7)
- Ebastine Impurity N2 (CAS 43076-61-5)
- Ebastine EP Impurity C (CAS 58258-01-8)
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- Ethyl 2-bromo-1-methyl-1H-imidazole-5-carboxylate (CAS 1936202-74-2)
- Propanoic acid, 2-[(1,3-dihydro-1,3-dioxo-2H-isoindol-2-yl)oxy]-2-methyl- (CAS 115761-50-7)
- Liraglutide Impurity 26 (CAS CATO-C4X-199226)
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