Regorafenib EP Impurity E CAS 2098799-13-2
| CAS No. | 2098799-13-2 |
| Molecular Formula | C35H23Cl2F7N6O5 |
| Molecular Weight | 811.49 g/mol |
| Category | Pharmacopoeial Impurity Standards / EP Impurities |
| Availability | In Stock |
Chemical Structure
Description
Regorafenib EP Impurity E (CAS 2098799-13-2) is a certified pharmaceutical impurity reference standard with the molecular formula C35H23Cl2F7N6O5 and a molecular weight of 811.49 g/mol.
Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution, Regorafenib EP Impurity E is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 811.49 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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 | C35H23Cl2F7N6O5 |
| Molecular Weight | 811.49 g/mol |
| Purity | >95% |
| 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) | 23.0 |
| UV Absorption | UV-absorbing |
| Structural Features | Aromatic ring present |
| CAS Registry Year (est.) | 1997 |
| Halogen Content | F/Cl-containing |
| Nitrogen Atoms | 6 |
Related Regorafenib Standards
- Regorafenib Impurity 11 (CAS CATO-C4X-104711)
- Regorafenib Impurity 59 (CAS CATO-C4X-104759)
- Regorafenib Impurity 57 (CAS CATO-C4X-104757)
- Regorafenib Impurity 12 (CAS CATO-C4X-104712)
- Regorafenib EP Impurity D (CAS 2438857-80-6)
- Regorafenib Impurity 84 (CAS CATO-C4X-104784)
- Regorafenib Impurity 9 (CAS CATO-C4X-10479)
- Regorafenib-13C-d3 N-Oxide (CAS 835621-11-9 (Unlabeled))
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- Indanofan (CAS 133220-30-1)
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