| CAS No. | CATO-C4X-100663 |
| Molecular Formula | C24H24ClFN4O4 |
| Molecular Weight | 486.92 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Afatinib Impurity 63.
CATO supplies Afatinib Impurity 63 (CAS CATO-C4X-100663), a pharmacopoeial impurity reference standard (molecular formula C24H24ClFN4O4, MW 486.92 g/mol) used for the identification and quantification of trace impurities in APIs.
Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution, Afatinib Impurity 63 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 486.92 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).
Recommended for quantitative analysis by HPLC, GC, LC-MS/MS, or GC-MS as an external calibration standard; it can also be used for spiked-recovery experiments, LOD/LOQ determination, and LC-MS/MS multiple-reaction-monitoring (MRM) calibration.
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 | C24H24ClFN4O4 |
| Molecular Weight | 486.92 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) | 14.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 4 |