| CAS No. | CATO-C4X-104876 |
| Molecular Formula | C28H36ClN5O3S |
| Molecular Weight | N/A |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Compared with other compounds in its class, the molecular weight of 672.16 g/mol gives Ceritinib Impurity 76 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.
CATO supplies Ceritinib Impurity 76 (CAS CATO-C4X-104876), a pharmacopoeial impurity reference standard (molecular formula C28H36ClN5O3SC2HF3O2, MW 672.16 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Ceritinib Impurity 76 (C28H36ClN5O3SC2HF3O2) contains a steroid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 13.0, corresponding to approximately 13 ring(s) or double-bond equivalent(s). With a molecular weight of 672.16 g/mol, it falls into the high-molecular-weight range. 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.
| Molecular Formula | C28H36ClN5O3S 2*C2HF3O2 |
| Molecular Weight | 672.16 g/mol |
| 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) | 13.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 5 |
| Sulfur Atoms | 1 |