| CAS No. | 2090542-75-7 |
| Molecular Formula | C7H7FN2O3 |
| Molecular Weight | 186.14 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
The occurrence of Osimertinib Impurity 13 is closely related to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.
CATO supplies Osimertinib Impurity 13 (CAS 2090542-75-7), a pharmacopoeial impurity reference standard (molecular formula C7H7FN2O3, MW 186.14 g/mol) used for the identification and quantification of trace impurities in APIs.
The molecular framework of Osimertinib Impurity 13 (C7H7FN2O3) is characterized by an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution, an aromatic ring system. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.
As a certified reference material (CRM), Osimertinib Impurity 13 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.
| Molecular Formula | C7H7FN2O3 |
| Molecular Weight | 186.14 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, water |
| 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 |
| CAS Registry Year (est.) | 1997 |
| Halogen Content | F-containing |
| Nitrogen Atoms | 2 |