Encorafenib Impurity 16 CAS CATO-C4X-324916

Purity ≥95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-324916
Molecular FormulaC19H29IN8O3
Molecular Weight544.39 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Encorafenib Impurity 16 CAS CATO-C4X-324916 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.

Encorafenib Impurity 16 (CAS CATO-C4X-324916) is a certified pharmaceutical impurity reference standard with the molecular formula C19H29IN8O3 and a molecular weight of 544.39 g/mol.

Based on its molecular formula C19H29IN8O3, Encorafenib Impurity 16 contains a steroid core, an amide group, a hydroxyl group, an ether linkage, iodine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 544.39 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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.

Physical & Chemical Properties

Molecular FormulaC19H29IN8O3
Molecular Weight544.39 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
Purity≥95%
StorageStore in a cool place (≤25°C), protect from light, keep sealed and dry
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 ContentI-containing
Nitrogen Atoms8

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