Safinamide Impurity 2 CAS 1160513-60-9
| CAS No. | 1160513-60-9 |
| Molecular Formula | C17H18FNO3 |
| Molecular Weight | 303.33 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The molecular framework of Safinamide Impurity 2 (C17H18FNO3) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
As a process- or degradation-related impurity, Safinamide Impurity 2 (CAS 1160513-60-9, C17H18FNO3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
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), Safinamide Impurity 2 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 | C17H18FNO3 |
| Molecular Weight | 303.33 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| Storage | Store at 2-8°C, 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) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1989 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Safinamide Standards
- Safinamide Impurity N1 (CAS 861398-52-9)
- Safinamide (CAS 133865-89-1)
- Safinamide Impurity 31 (CAS 202825-43-2)
- Safinamide Impurity 32 (CAS 133865-88-0)
- Safinamide impurity 54 (CAS CATO-C4X-159054)
- Safinamide Impurity 55 (CAS CATO-C4X-159055)
- Safinamide impurity 6 (CAS 174756-44-6)
- Safinamide Impurity 22 (CAS 1000370-31-9)
Recommended Standards
- Retigabine impurity 12 (CAS CATO-C4X-13152)
- Epalrestat Impurity 3 (CAS 794510-29-5)
- Retigabine impurity 9 (CAS CATO-C4X-13149)
- Dotinurad Impurity 50 (CAS CATO-C4X-249450)
- Insulin Degludec Impurity 13 (CAS CATO-C4X-215713)
- Ethacridine Lactate Impurity 26 (CAS CATO-C4X-260926)
- Avatrombopag Impurity 96 (CAS CATO-C4X-223496)
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- trans-tert-Butyl 4-(aminomethyl)cyclohexanecarboxylate hydrochloride (CAS 38698-16-7)
- 3-(3-Bromophenyl)-1h-pyrazole-4-carbaldehyde (CAS 696646-49-8)
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