Regorafenib Impurity 45 CAS CATO-C4X-104745
| CAS No. | CATO-C4X-104745 |
| Molecular Formula | C18H13F2N3O3 |
| Molecular Weight | 357.31 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
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.
CATO supplies Regorafenib Impurity 45 (CAS CATO-C4X-104745), a pharmacopoeial impurity reference standard (molecular formula C18H13F2N3O3, MW 357.31 g/mol) used for the identification and quantification of trace impurities in APIs.
Structurally, Regorafenib Impurity 45 (C18H13F2N3O3) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 13.0, corresponding to approximately 13 ring(s) or double-bond equivalent(s). With a molecular weight of 357.31 g/mol, it falls into the moderately-high-molecular-weight range. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.
As a certified reference material (CRM), Regorafenib Impurity 45 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 | C18H13F2N3O3 |
| Molecular Weight | 357.31 g/mol |
| Appearance | Pale yellow to yellow crystalline powder. (slight halide-like odor, low volatility) |
| 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; Contains ester bond; hydrolyzes under strong alkaline conditions |
| Degree of Unsaturation (DBE) | 13.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| Halogen Content | F-containing |
| Nitrogen Atoms | 3 |
Related Regorafenib Standards
- Regorafenib Impurity 82 (CAS CATO-C4X-104782)
- Regorafenib Impurity 81 (CAS CATO-C4X-104781)
- Regorafenib Impurity 37 (CAS CATO-C4X-104737)
- Regorafenib Impurity 18 (CAS CATO-C4X-104718)
- Regorafenib Impurity N2 (CAS 1333390-56-9)
- Regorafenib Impurity 19 (CAS 2098799-12-1)
- Regorafenib Impurity 83 (CAS CATO-C4X-104783)
- Regorafenib Impurity 23 (CAS CATO-C4X-104723)
Recommended Standards
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- D-Melphalan (CAS 13045-94-8)
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