Clozapine EP Impurity B CAS 263366-81-0
| CAS No. | 263366-81-0 |
| Molecular Formula | C30H24Cl2N6 |
| Molecular Weight | 539.46 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Clozapine EP Impurity B is closely related to a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
As a process- or degradation-related impurity, Clozapine EP Impurity B (CAS 263366-81-0, C30H24Cl2N6) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C30H24Cl2N6, Clozapine EP Impurity B contains a nitrogen-containing heterocyclic scaffold, a nitrile group, chlorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 539.46 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.
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 | C30H24Cl2N6 |
| Molecular Weight | 539.46 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | >95% |
| Storage | Store at room temperature, protect from light |
| 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) | 21.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 2025 |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 6 |
Related Clozapine Standards
- Clozapine Impurity 25 (CAS CATO-C4X-134025)
- Clozapine-5-N-Glucuronide Sodium Salt (CAS 390651-03-3)
- Clozapine Impurity 21 (CAS CATO-C4X-134021)
- Clozapine Impurity 14 (CAS 1025951-76-1)
- Clozapine Impurity 15 (CAS 156632-03-0)
- Clozapine EP Impuirty C-D8 N-nitroso (CAS CATO-C4X-134018)
- Clozapine EP Impurity D (CAS 65514-71-8)
- Clozapine N-Oxide (CAS 34233-69-7)
Recommended Standards
- Triamcinolone Acetonide Impurity 47 (CAS 25092-29-9)
- 4-Chloro-N-(4-chlorophenyl)-N-[(2,3-diphenyl-1,2-oxazolidin-5-yl)methyl]benzene-1-sulfonamide (CAS 306978-08-5)
- 2-(3-Bromophenyl)-2',6,6'-triphenyl-4,4'-bipyridine (CAS 1956340-64-9)
- Tributyl(5’-hexyl-[2,2’-bithiophen]-5-yl)stannane (CAS 211737-37-0)
- Minoxidil Impurity 24 (CAS CATO-C4X-170024)
- Cefminox Impurity 15 (CAS CATO-C4X-192615)
- Vonoprazan Fumarate Impurity 28 (CAS CATO-C4X-102028)
- 1-Methyl-6,7-dimethoxy-3,4-dihydroisoquinoline, 99+% (CAS 4721-98-6)
- 2-(4-Hydroxy-6-(phenylthio)isoquinoline-3-carboxamido)acetic acid (CAS 808116-39-4)
- 4-(3,4-Dimethylphenyl)-5-methyl-4H-1,2,4-triazole-3-thiol (CAS 663181-78-0)
- 2,2-Difluoro-1,3-diphenylpropane-1,3-dione (CAS 365-00-4)
- Methyl 5-(N-methyl-N-(p-tolyl)sulfamoyl)-1H-pyrazole-4-carboxylate (CAS 1260995-46-7)
- Baricitinib Impurity 127 (CAS CATO-C4X-2260127)
- Palmitoyl Tripeptide-8 TFA salt (CAS 936544-53-5)
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