Ceritinib Impurity 50 CAS CATO-C4X-104850
| CAS No. | CATO-C4X-104850 |
| Molecular Formula | C10H12ClNO3 |
| Molecular Weight | 229.66 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Ceritinib Impurity 50 (CAS CATO-C4X-104850) is a certified pharmaceutical impurity reference standard with the molecular formula C10H12ClNO3 and a molecular weight of 229.66 g/mol.
Structurally, Ceritinib Impurity 50 (C10H12ClNO3) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 5.0, corresponding to approximately 5 ring(s) or double-bond equivalent(s). With a molecular weight of 229.66 g/mol, it falls into the medium-molecular-weight range. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.
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 | C10H12ClNO3 |
| Molecular Weight | 229.66 g/mol |
| Appearance | Off-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation |
| Solubility (reference) | Soluble in methanol, ethanol, DMSO |
| 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) | 5.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | Cl-containing |
| Nitrogen Atoms | 1 |
Related Ceritinib Standards
- Ceritinib Impurity 36 (CAS CATO-C4X-104836)
- Ceritinib Impurity 40 (CAS CATO-C4X-104840)
- Ceritinib Impurity 20 (CAS CATO-C4X-104820)
- Ceritinib Impurity 28 (CAS CATO-C4X-104828)
- Ceritinib Impurity 15 (CAS CATO-C4X-104815)
- Ceritinib Impurity 49 (CAS CATO-C4X-104849)
- Ceritinib Impurity 88 (CAS 1823331-67-4)
- Ceritinib Impurity 30 (CAS CATO-C4X-104830)
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