Safinamide Impurity 28 CAS CATO-C4X-159028
| CAS No. | CATO-C4X-159028 |
| Molecular Formula | C19H22FNO3 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Safinamide Impurity 28 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
Safinamide Impurity 28 (CAS CATO-C4X-159028) is a certified pharmaceutical impurity reference standard with the molecular formula C19H22FNO3HCl and a molecular weight of 367.84 g/mol.
Safinamide Impurity 28 (C19H22FNO3HCl) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. 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 presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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 | C19H22FNO3 HCl |
| Molecular Weight | 367.84 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| 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) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 1 |
Related Safinamide Standards
- Safinamide Impurity 16 (CAS 1000370-24-0)
- Safinamide Impurity 37 (CAS 1000370-27-3)
- Safinamide Impurity 47 (CAS 1000370-28-4)
- Safinamide Impurity 22 (CAS 1000370-31-9)
- Safinamide impurity 52 (CAS 100370-27-3)
- Safinamide-D4 (CAS 1147299-69-1)
- Safinamide Impurity 2 (CAS 1160513-60-9)
- Safinamide Impurity 17 (CAS 1205608-96-3)
Recommended Standards
- Everolimus Impurity 33 (CAS 908340-97-6)
- Mianserin Impurity 105 (CAS CATO-C4X-1369105)
- Omarigliptin Impurity 16 (CAS 1819364-01-6)
- (3-Chloro-4-((4-fluorophenyl)carbamoyl)phenyl)boronic acid (CAS 2096333-08-1)
- 2-(2-Azabicyclo[2.1.1]Hexan-1-yl)acetic acid (CAS 721394-81-6)
- 2-(3,6-Dihydro-2h-pyran-4-yl)ethan-1-amine hydrochloride (CAS 1423026-21-4)
- 5-Cyano-6-methyl-N-propylpicolinamide (CAS 1147666-53-2)
- 4H,6H,7H-thiopyrano[4,3-d][1,3]thiazol-2-amine (CAS 61764-33-8)
- Hydrocortisone EP Impurity E (CAS 7753-60-8)
- Anti-Inflammatory Peptide 1 (CAS 118850-71-8)
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