Neratinib Impurity 40 CAS 848133-75-5
| CAS No. | 848133-75-5 |
| Molecular Formula | C14H13N3O3 |
| Molecular Weight | 271.27 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Neratinib Impurity 40 (CAS 848133-75-5, C14H13N3O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
The molecular framework of Neratinib Impurity 40 (C14H13N3O3) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. 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.
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.
Physical & Chemical Properties
| Molecular Formula | C14H13N3O3 |
| Molecular Weight | 271.27 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| Purity | 97%+ |
| 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) | 10.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1987 |
| Nitrogen Atoms | 3 |
Related Neratinib Standards
- Neratinib Impurity 27 (CAS CATO-C4X-113427)
- Neratinib Impurity 26 (CAS CATO-C4X-113426)
- Neratinib Impurity 56 (CAS CATO-C4X-113456)
- Neratinib Impurity 38 (CAS 2240142-43-0)
- Neratinib Impurity 42 (CAS 1201080-23-0)
- Neratinib Impurity 24 (CAS 848133-76-6)
- Neratinib Impurity 43 (CAS 1222172-49-7)
- Neratinib Impurity 60 (CAS CATO-C4X-113460)
Recommended Standards
- Sorafenib EP Impurity B (CAS 2004659-84-9)
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- Formoterol Impurity 41 (CAS 51582-41-3)
- Cloxacillin Impurity 9 (CAS CATO-C4X-15979)
- Imatinib Impurity 57 (CAS 581076-64-4)
- Pimecrolimus Impurity 22 (CAS 137712-89-1)
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