Ceritinib Impurity 36 CAS CATO-C4X-104836
| CAS No. | CATO-C4X-104836 |
| Molecular Formula | C10H12ClNO3 |
| Molecular Weight | 229.66 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Ceritinib Impurity 36.
Ceritinib Impurity 36 (CAS CATO-C4X-104836) is a certified pharmaceutical impurity reference standard with the molecular formula C10H12ClNO3 and a molecular weight of 229.66 g/mol.
The molecular framework of Ceritinib Impurity 36 (C10H12ClNO3) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by its high hydrophobicity (logP), 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.
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 36 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 | 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 40 (CAS CATO-C4X-104840)
- Ceritinib Impurity 50 (CAS CATO-C4X-104850)
- 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)
Recommended Standards
- Mosapride Impurity 2 (CAS CATO-C4X-10442)
- Baclofen Impurity 53 (CAS CATO-C4X-101253)
- Baclofen Impurity 46 (CAS CATO-C4X-101246)
- Cetilistat Impurity 8 (CAS 62072-62-2)
- Dextromethorphan Impurity 37 (CAS 2382909-24-0)
- Tirofiban Impurity 44 (CAS CATO-C4X-125444)
- Lorazepam EP Impurity C (CAS 2955-37-5)
- Ethyl 2-(1-aminocyclopropyl)acetate hydrochloride (CAS 1554076-31-1)
- Hamaudol (CAS 735-46-6)
- 1-Chloro-3-fluoro-4-methyl-2-(trifluoromethyl)benzene (CAS 1099597-48-4)
- Pb And Cd In Water (CAS CATO-CCRM106005)
- 3-(Dimethylamino)oxetane-3-carbonitrile (CAS 1414513-73-7)
- 3-(Cyanomethyl)-5-methoxy-1H-pyrrolo[2,3-c]pyridine-2-carboxylic acid (CAS 22772-37-8)
- Insulin Degludec Impurity 18 (CAS CATO-C4X-215718)
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