Regorafenib Impurity 35 CAS CATO-C4X-104735

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-104735
Molecular FormulaC13H11FN2O2
Molecular Weight246.24 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Regorafenib Impurity 35 CAS CATO-C4X-104735 chemical structure

Description

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.

Regorafenib Impurity 35 (CAS CATO-C4X-104735) is a certified pharmaceutical impurity reference standard with the molecular formula C13H11FN2O2 and a molecular weight of 246.24 g/mol.

Structurally, Regorafenib Impurity 35 (C13H11FN2O2) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 9.0, corresponding to approximately 9 ring(s) or double-bond equivalent(s). With a molecular weight of 246.24 g/mol, it falls into the medium-molecular-weight range. The high carbon-to-hydrogen ratio imparts good lipophilicity, allowing liquid-liquid extraction with non-polar solvents such as n-hexane or ethyl acetate.

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.

Physical & Chemical Properties

Molecular FormulaC13H11FN2O2
Molecular Weight246.24 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityMay 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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF-containing
Nitrogen Atoms2

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