Risperidone impurity 46 CAS 106266-11-9
| CAS No. | 106266-11-9 |
| Molecular Formula | C23H28N4O3 |
| Molecular Weight | 408.49 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
As a process- or degradation-related impurity, Risperidone impurity 46 (CAS 106266-11-9, C23H28N4O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Structurally, Risperidone impurity 46 (C23H28N4O3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 12.0, corresponding to approximately 12 ring(s) or double-bond equivalent(s). With a molecular weight of 408.49 g/mol, it falls into the moderately-high-molecular-weight range. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
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.
Physical & Chemical Properties
| Molecular Formula | C23H28N4O3 |
| Molecular Weight | 408.49 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >90% |
| Storage | Store in a cool place (≤25°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 |
| Degree of Unsaturation (DBE) | 12.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1987 |
| Nitrogen Atoms | 4 |
Related Risperidone Standards
- Risperidone EP Impurity D (CAS 1199589-74-6)
- Risperidone Impurity 27 (CAS 1005191-81-0)
- Risperidone Impurity 42 (CAS CATO-C4X-111142)
- Risperidone Impurity (CAS CATO-C4X-111144)
- Risperidone Impurity (CAS CATO-C4X-111145)
- Risperidone (CAS 106266-06-2)
- Risperidone Impurity 32 (CAS 108855-18-1)
- Risperidone USP Related Compound G (CAS 152542-00-2)
Recommended Standards
- Tert-butyl (S)-3-((((9H-fluoren-9-yl)methoxy)carbonyl)amino)pyrrolidine-1-carboxylate (CAS 307531-88-0)
- Terbutaline impurity 96 (CAS CATO-C4X-118396)
- Tert-butyl (R)-3-((((9H-fluoren-9-yl)methoxy)carbonyl)amino)pyrrolidine-1-carboxylate (CAS 352530-40-6)
- Loxoprofen impurity 122 (CAS CATO-C4X-1488122)
- Regadenoson Impurity 37 (CAS 50427-65-1)
- Sorafenib Impurity 21 (CAS CATO-C4X-112421)
- Dotinurad Impurity 102 (CAS CATO-C4X-2494102)
- 1-(2-Nitro-4-(trifluoromethyl)phenyl)-1h-pyrazole-4-carboxylic acid (CAS 1006952-22-2)
- 6-(4-bromophenyl)-2H,3H,5H,6H-imidazo[2,1-b][1,3]thiazole (CAS 6646-46-4)
- 2,3',4,4',5-Pentachlorodiphenyl ether (CAS 60123-65-1)
- 2,6-Dichloro-n'-hydroxybenzene-1-carboximidamide (CAS 23505-21-7)
- 4-(Difluoromethyl)-3-methoxy-6-(trifluoromethyl)picolinonitrile (CAS 1804374-70-6)
- Ethyl 1-carbamoylcyclopropane-1-carboxylate (CAS 6914-75-6)
- Semaglutide impurity 258 (CAS CATO-C4X-2226258)
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