Cibenzoline Impurity (N-(2-aminoethyl-2,2-diphenyl Cyclopropanecarboxamide) CAS 109546-07-8
| CAS No. | 109546-07-8 |
| Molecular Formula | C18H20N2O |
| Molecular Weight | 280.36 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
As a process- or degradation-related impurity, Cibenzoline Impurity (N-(2-aminoethyl-2,2-diphenyl Cyclopropanecarboxamide) (CAS 109546-07-8, C18H20N2O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Cibenzoline Impurity (N-(2-aminoethyl-2,2-diphenyl Cyclopropanecarboxamide) (C18H20N2O) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. 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.
Physical & Chemical Properties
| Molecular Formula | C18H20N2O |
| Molecular Weight | 280.36 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1988 |
| Nitrogen Atoms | 2 |
Related Cibenzoline Standards
Recommended Standards
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- Liraglutide Impurity 25 (CAS CATO-C4X-199225)
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