| CAS No. | CATO-C4X-102535 |
| Molecular Formula | C13H9Br2Cl2FN2O |
| Molecular Weight | 458.94 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
The occurrence of Crizotinib impurity 35 is closely related to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine/bromine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
Crizotinib impurity 35 (CAS CATO-C4X-102535) is a certified pharmaceutical impurity reference standard with the molecular formula C13H9Br2Cl2FN2O and a molecular weight of 458.94 g/mol.
Based on its molecular formula C13H9Br2Cl2FN2O, Crizotinib impurity 35 contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine/bromine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 458.94 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.
CATO manufactures Crizotinib impurity 35 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.
| Molecular Formula | C13H9Br2Cl2FN2O |
| Molecular Weight | 458.94 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| 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) | 8.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F/Cl/Br-containing |
| Nitrogen Atoms | 2 |