Neratinib Impurity 54 CAS CATO-C4X-113454
| CAS No. | CATO-C4X-113454 |
| Molecular Formula | C30H30N6O3 |
| Molecular Weight | 522.60 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
As a process- or degradation-related impurity, Neratinib Impurity 54 (CAS CATO-C4X-113454, C30H30N6O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.
Based on its molecular formula C30H30N6O3, Neratinib Impurity 54 contains a steroid core, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 522.60 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).
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 | C30H30N6O3 |
| Molecular Weight | 522.60 g/mol |
| Appearance | Pale yellow to yellow crystalline powder |
| 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 |
| Degree of Unsaturation (DBE) | 19.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Nitrogen Atoms | 6 |
Related Neratinib Standards
- Neratinib Impurity 13 (CAS 1144516-21-1)
- Neratinib Impurity 10 (CAS 1144516-13-1)
- Neratinib Impurity 14 (CAS 1144516-14-2)
- Neratinib Impurity 21 (CAS 1144516-15-3)
- Neratinib Impurity 62 (CAS CATO-C4X-113462)
- Neratinib Impurity 5 (CAS CATO-C4X-11345)
- Neratinib Impurity 7 (CAS 915788-27-1)
- Neratinib Impurity 17 (CAS 1144516-19-7)
Recommended Standards
- Imatinib Impurity 78 (CAS CATO-C4X-106878)
- Mupirocin EP Impurity D Sodium Salt (CAS 116182-43-5)
- Imatinib Impurity 72 (CAS CATO-C4X-106872)
- Ethyl 20-(tosyloxy)-3,6,9,12,15,18-hexaoxaicosanoate (CAS 1254951-77-3)
- Valganciclovir EP Impurity Q Isomer (CAS CATO-C4X-177430)
- Trelagliptin impurity 87 (CAS 2270843-82-6)
- Desmopressin Impurity 44 (CAS CATO-C4X-221544)
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- 2-{N-[3-(trifluoromethyl)phenyl]4-chlorobenzenesulfonamido}acetic acid (CAS 478260-84-3)
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