Risperidone EP Impurity B CAS 132961-05-8
| CAS No. | 132961-05-8 |
| Molecular Formula | C23H28F2N4O2 |
| Molecular Weight | 430.49 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The molecular framework of Risperidone EP Impurity B (C23H28F2N4O2) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
Risperidone EP Impurity B (CAS 132961-05-8) is a certified pharmaceutical impurity reference standard with the molecular formula C23H28F2N4O2 and a molecular weight of 430.49 g/mol.
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 certified reference material (CRM), Risperidone EP Impurity B meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.
Physical & Chemical Properties
| Molecular Formula | C23H28F2N4O2 |
| Molecular Weight | 430.49 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| 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) | 11.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1994 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 4 |
Related Risperidone Standards
- Risperidone EP Impurity A and B(Mixture of E and Z Isomers) (CAS 158697-66-6)
- Risperidone EP Impurity A (CAS 691007-09-7)
- 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
- Lansoprazole impurity 63 (CAS 763899-08-7)
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- Cefamandole Impurity 10 (CAS CATO-C4X-122110)
- Canagliflozin Impurity 52 (CAS CATO-C4X-112352)
- Urapidil Impurity 57 (CAS CATO-C4X-192457)
- 4-Chloro-2-(4-fluorophenyl)-6-nitroquinoline (CAS 1416440-17-9)
- 5,6-Dimethyl-4,5,6,7-tetrahydroisoxazolo[4,3-c]pyridine (CAS 63501-02-0)
- Perfluoro(1,3-diethylcyclohexane) (CAS 335-23-9)
- 1,1-Bis(2-bromoethyl)cyclopropane (CAS 1232431-84-3)
- 3-(((2-Methylbenzyl)oxy)methyl)piperidine hydrochloride (CAS 1185303-83-6)
- Pimobendan Impurity 6 (CAS CATO-C4X-24616)
- D-Ile12-Tirzepatide (CAS CATO-CPTD788921)
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