Risperidone EP Impurity L (HCl) CAS 93076-03-0
| CAS No. | 93076-03-0 |
| Molecular Formula | C11H16Cl2N2 |
| Molecular Weight | 263.16 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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 process- or degradation-related impurity, Risperidone EP Impurity L (HCl) (CAS 93076-03-0, C11H16Cl2N2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine substitution, Risperidone EP Impurity L (HCl) is typically off-white to pale yellow low-melting solid. Its solid-state physicochemical attributes — including a molecular weight of 263.16 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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).
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 | C11H16Cl2N2 |
| Molecular Weight | 263.16 g/mol |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in DMSO, DMF, methanol |
| Stability | May oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light |
| Degree of Unsaturation (DBE) | 4.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1983 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 2 |
Related Risperidone Standards
- Risperidone RC 2 (CAS 25519-77-1)
- Risperidone Impurity 19 (CAS 84162-82-3)
- 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 Impurity 9 (CAS 158697-68-8)
- Risperidone EP Impurity L (CAS 63234-80-0)
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