Safinamide impurity 54 CAS CATO-C4X-159054
| CAS No. | CATO-C4X-159054 |
| Molecular Formula | C17H19FN2O2 |
| Molecular Weight | 302.34 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Safinamide impurity 54 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
Safinamide impurity 54 (CAS CATO-C4X-159054) is a certified pharmaceutical impurity reference standard with the molecular formula C17H19FN2O2 and a molecular weight of 302.34 g/mol.
Structurally, Safinamide impurity 54 (C17H19FN2O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 9.0, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 302.34 g/mol, it falls into the moderately-high-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
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 | C17H19FN2O2 |
| Molecular Weight | 302.34 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 sealed and dry |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Hygroscopic; reseal immediately after opening; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 2 |
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 55 (CAS CATO-C4X-159055)
- Safinamide impurity 6 (CAS 174756-44-6)
- Safinamide Impurity 2 (CAS 1160513-60-9)
- Safinamide Impurity 22 (CAS 1000370-31-9)
Recommended Standards
- Salicylic Acid Impurity 22 (CAS CATO-C4X-190222)
- Propofol Impurity 51 (CAS CATO-C4X-147351)
- Salicylic acid impurity 32 (CAS CATO-C4X-190232)
- Azathioprine Impurity 14 (CAS 49808-20-0)
- Pranoprofen Impurity 43 (CAS CATO-C4X-181143)
- Ezetimibe Impurity 86 (CAS 1650568-82-3)
- Aripiprazole EP Impurity B DiHCl (CAS 864512-47-0)
- N-Acetylcysteine-d3 (CAS 131685-11-5)
- 1-(4-Chloro-pyridin-2-yl)-1-methyl-ethylamine dihydrochloride (CAS 1373223-72-3)
- 5-(Aminomethyl)-3-(difluoromethyl)-6-methoxypyridin-2-amine (CAS 1806898-65-6)
- Cefmetazole Impurity 70 (CAS CATO-C4X-150770)
- 7-Fluoroquinazoline (CAS 16499-45-9)
- (S)-2-(tert-Butoxycarbonyl)-2-azaspiro[4.4]nonane-3-carboxylic acid (CAS 1608495-27-7)
- Semaglutide Impurity 177 (CAS CATO-C4X-2226177)
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