Risperidone EP Impurity E CAS 1346602-28-5
| CAS No. | 1346602-28-5 |
| Molecular Formula | C24H29FN4O2 |
| Molecular Weight | 424.51 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Risperidone EP Impurity E 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.
CATO supplies Risperidone EP Impurity E (CAS 1346602-28-5), a pharmacopoeial impurity reference standard (molecular formula C24H29FN4O2, MW 424.51 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Risperidone EP Impurity E is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 424.51 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 | C24H29FN4O2 |
| Molecular Weight | 424.51 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor) |
| Purity | >95% |
| 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 12.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1991 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 4 |
Related Risperidone Standards
- 9-Methyl Risperidone (CAS 138271-01-9)
- Risperidone RC 23 (CAS 84163-48-4)
- Risperidone Impurity 29 (CAS 832747-55-4)
- Risperidone Impurity 30 (CAS 1894509-66-0)
- Risperidone Impurity 39 (CAS CATO-C4X-111139)
- Risperidone Pyrimidinone-N-oxide (CAS 1301724-91-3)
- Risperidone EP Impurity C (CAS 130049-85-3)
- Risperidone EP Impurity C ((S)-Isomer) (CAS 147663-01-2)
Recommended Standards
- tert-Butyl 3-((1-(4-fluorobenzyl)-1H-benzo[d]imidazol-2-yl)amino)piperidine-1-carboxylate (CAS 885270-89-3)
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- N-(4-methylpyrimidin-2-yl)-4-(2,6,6-trimethyl-4-oxo-4,5,6,7-tetrahydro-1H-indol-1-yl)benzenesulfonamide (CAS 1024333-97-8)
- Clopidogrel Impurity 114 (CAS CATO-C4X-1029114)
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- Ethyl 2-(5-bromo-2-oxoindolin-1-yl)acetate (CAS 881608-39-5)
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Why CATO?
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