Risperidone Impurity 9 CAS 158697-68-8
| CAS No. | 158697-68-8 |
| Molecular Formula | C15H17F2NO3 |
| Molecular Weight | 297.30 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Risperidone Impurity 9 (C15H17F2NO3) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine 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. 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, Risperidone Impurity 9 (CAS 158697-68-8, C15H17F2NO3) 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.
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 | C15H17F2NO3 |
| Molecular Weight | 297.30 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry, 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) | 7.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2002 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |
Related Risperidone Standards
- Risperidone RC 2 (CAS 25519-77-1)
- Risperidone Impurity 19 (CAS 84162-82-3)
- Risperidone EP Impurity L (HCl) (CAS 93076-03-0)
- Risperidone Impurity 3 (CAS 84162-80-1)
- Risperidone Impurity N1 (CAS 1797131-18-0)
- Risperidone Impurity 24 (CAS CATO-C4X-111124)
- Risperidone RC 24 (Base) (CAS 64671-19-8)
- Risperidone EP Impurity L (CAS 63234-80-0)
Recommended Standards
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