Safinamide Impurity 18 CAS 56442-17-2
| CAS No. | 56442-17-2 |
| Molecular Formula | C14H11FO2 |
| Molecular Weight | 230.23 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, Safinamide Impurity 18 (CAS 56442-17-2, C14H11FO2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Safinamide Impurity 18 (C14H11FO2) contains a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, a polycyclic aromatic system. Halogen substitution raises its density and boiling point, 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.
Physical & Chemical Properties
| Molecular Formula | C14H11FO2 |
| Molecular Weight | 230.23 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| 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) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1973 |
| Halogen Content | F-containing |
Related Safinamide Standards
- Safinamide impurity 01 (CAS 1443302-79-1)
- Safinamide Impurity 19 (CAS 70627-20-2)
- Safinamide Impurity 21 (CAS 590353-54-1)
- Safinamide Impurity 44 (CAS 172685-67-5)
- Safinamide Impurity 5 (CAS 690969-16-5)
- Safinamide Impurity 17 (CAS 1205608-96-3)
- Safinamide Impurity 33 (CAS 405-85-6)
- Safinamide Impurity 20 (CAS 4397-53-9)
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