Dacomitinib Impurity N4 CAS 2190490-31-2
| CAS No. | 2190490-31-2 |
| Molecular Formula | C19H16ClFN4O3 |
| Molecular Weight | 402.81 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Dacomitinib Impurity N4.
As a process- or degradation-related impurity, Dacomitinib Impurity N4 (CAS 2190490-31-2, C19H16ClFN4O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Dacomitinib Impurity N4 (C19H16ClFN4O3) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. 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).
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.
As a certified reference material (CRM), Dacomitinib Impurity N4 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.
Physical & Chemical Properties
| Molecular Formula | C19H16ClFN4O3 |
| Molecular Weight | 402.81 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) | 13.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1998 |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 4 |
Related Dacomitinib Standards
- Dacomitinib Impurity 2 (CAS CATO-C4X-20862)
- Dacomitinib Impurity 33 (CAS CATO-C4X-208633)
- Dacomitinib Impurity 24 (CAS CATO-C4X-208624)
- Dacomitinib Impurity 11 (CAS CATO-C4X-208611)
- Dacomitinib Impurity 27 (CAS CATO-C4X-208627)
- Dacomitinib Impurity 34 (CAS CATO-C4X-208634)
- Dacomitinib Impurity 41 (CAS CATO-C4X-208641)
- Dacomitinib Impurity 12 (CAS CATO-C4X-208612)
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