| CAS No. | CATO-C4X-100676 |
| Molecular Formula | C14H22F3NO4 |
| Molecular Weight | 325.32 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
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 supplies Afatinib Impurity 76 (CAS CATO-C4X-100676), a pharmacopoeial impurity reference standard (molecular formula C14H22F3NO4, MW 325.32 g/mol) used for the identification and quantification of trace impurities in APIs.
Based on its molecular formula C14H22F3NO4, Afatinib Impurity 76 contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 325.32 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).
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 | C14H22F3NO4 |
| Molecular Weight | 325.32 g/mol |
| Appearance | White to pale yellow crystalline powder. (slight halide-like odor, low volatility) |
| Purity | 97%+ |
| Storage | Store at 2-8°C, protect from light, keep sealed and dry |
| Solubility (reference) | Soluble in methanol, acetonitrile, DMSO, water (slightly soluble) |
| 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) | 3.0 |
| UV Absorption | UV-absorbing |
| Halogen Content | F-containing |
| Nitrogen Atoms | 1 |