Ceritinib Impurity 53 CAS CATO-C4X-104853
| CAS No. | CATO-C4X-104853 |
| Molecular Formula | C22H26N2O3 |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
The occurrence of Ceritinib Impurity 53 is closely related to a flavonoid 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.
As a process- or degradation-related impurity, Ceritinib Impurity 53 (CAS CATO-C4X-104853, C22H26N2O3C2HF3O2) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Ceritinib Impurity 53 (C22H26N2O3C2HF3O2) is characterized by a flavonoid 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. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.
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), Ceritinib Impurity 53 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 | C22H26N2O3 C2HF3O2 |
| Molecular Weight | 480.48 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 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 2 |
Related Ceritinib Standards
- Ceritinib Impurity 86 (CAS /)
- Ceritinib (CAS 1032900-25-6)
- Ceritinib dihydrochloride (CAS 1380575-43-8)
- Ceritinib Impurity 88 (CAS 1823331-67-4)
- Ceritinib Impurity 87 (CAS 2976-70-7（free base))
- Ceritinib Impurity 85 (CAS 761440-17-9)
- Ceritinib Impurity 19 (CAS 771555-72-7)
- Ceritinib Impurity 2 (CAS 861343-73-9)
Recommended Standards
- Cefazolin Impurity 38 (CAS CATO-C4X-157738)
- Fenofibrate Impurity 15 (CAS 34183-01-2)
- Edoxaban Impurity 22 (CAS 1255529-26-0)
- 3-Amino-4-fluoropicolinamide (CAS 1805741-35-8)
- 6-Bromo-2-(4-bromophenyl)-5-methyl-2H-indazole-4,7-dione (CAS 112664-92-3)
- 2-(4-(Methylthio)phenoxy)benzaldehyde (CAS 364323-64-8)
- 2-(4-((E)-2-(5-((E)-2-(Benzyloxy)-4-(dibutylamino)styryl)thiophen-2-yl)vinyl)-3-cyano-5-phenyl-5-(trifluoromethyl)furan-2(5H)-ylidene)malononitrile (CAS 1267603-73-5)
- N-(5-Amino-2-methylphenyl)-2-(2-methoxyphenoxy)-propanamide (CAS 1020723-35-6)
- N-Boc-PEG10-alcohol (CAS 2238844-74-9)
- Semaglutide Impurity 3 (CAS CATO-C4X-22263)
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