| CAS No. | 1222172-50-0 |
| Molecular Formula | C15H17N3O4 |
| Molecular Weight | 303.31 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
As a certified reference material (CRM), Neratinib Impurity 44 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.
CATO supplies Neratinib Impurity 44 (CAS 1222172-50-0), a pharmacopoeial impurity reference standard (molecular formula C15H17N3O4, MW 303.31 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, Neratinib Impurity 44 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 303.31 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).
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.
| Molecular Formula | C15H17N3O4 |
| Molecular Weight | 303.31 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | >95% |
| Storage | Store at 2-8°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 |
| Degree of Unsaturation (DBE) | 9.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1990 |
| Nitrogen Atoms | 3 |