Risperidone EP Impurity H CAS 158697-67-7
| CAS No. | 158697-67-7 |
| Molecular Formula | C23H27F2N3O2 |
| Molecular Weight | 415.48 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a certified reference material (CRM), Risperidone EP Impurity H 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.
As a process- or degradation-related impurity, Risperidone EP Impurity H (CAS 158697-67-7, C23H27F2N3O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Owing to a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution, Risperidone EP Impurity H is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 415.48 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 | C23H27F2N3O2 |
| Molecular Weight | 415.48 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| 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.) | 2002 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 3 |
Related Risperidone Standards
- Risperidone-d4 (CAS 1020719-76-9)
- Risperidone-d6 (CAS 1225444-65-4)
- Risperidone USP Related Compound G (CAS 152542-00-2)
- Methyl Risperidone (CAS 106266-08-4)
- 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)
Recommended Standards
- (3S)-3-(9H-fluoren-9-ylmethoxycarbonylamino)-4-(4-methylphenyl)butanoic acid (3S)-3-(9H-fluoren-9-ylmethoxycarbonylamino)-4-(p-tolyl)butanoic acid (3S)-3-(9H-fluoren-9-ylmethoxycarbonylamino)-4-(p-tolyl)butyric acid (3S)-3-[[9H-fluoren-9-ylmethoxy(oxo)methyl]amino]-4-(4-methylphenyl)butanoic acid 270062-97-0 Fmoc-(S)-3-Amino-4-(4-methylphenyl)-butyric acid (CAS 270062-97-0)
- Atracurium Impurity 75 (CAS CATO-C4X-185075)
- (3R)-3-(9H-fluoren-9-ylmethoxycarbonylamino)-4-(4-methylphenyl)butanoic acid (3R)-3-(9H-fluoren-9-ylmethoxycarbonylamino)-4-(p-tolyl)butanoic acid (3R)-3-(9H-fluoren-9-ylmethoxycarbonylamino)-4-(p-tolyl)butyric acid (3R)-3-[[9H-fluoren-9-ylmethoxy(oxo)methyl]amino]-4-(4-methylphenyl)butanoic acid 269398-86-9 Fmoc-(R)-3-Amino-4-(4-methylphenyl)-butyric acid (CAS 269398-86-9)
- Esmolol Impurity 64 (CAS CATO-C4X-189164)
- Oclacitinib impurity 28 (CAS CATO-C4X-301828)
- Esmolol Impurity 60 (CAS CATO-C4X-189160)
- Hydantoin Impurity 13 (CAS CATO-C4X-214613)
- N-Acetylethyleneimine (CAS 460-07-1)
- 3-methyl-3,9-diazaspiro[5.6]dodecane dihydrochloride (CAS 2060036-93-1)
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- Isoescin IA (CAS 219944-39-5)
- 2-m-Tolylsulfanyl-ethylamine (CAS 104863-93-6)
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