Afatinib Impurity 76 CAS CATO-C4X-100676

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-100676
Molecular FormulaC14H22F3NO4
Molecular Weight325.32 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Afatinib Impurity 76 CAS CATO-C4X-100676 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 Afatinib Impurity 76 (CAS CATO-C4X-100676), a pharmacopoeial impurity reference standard (molecular formula C14H22F3NO4, MW 325.32 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C14H22F3NO4, Afatinib Impurity 76 contains an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine substitution; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 325.32 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).

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 FormulaC14H22F3NO4
Molecular Weight325.32 g/mol
AppearanceWhite to pale yellow crystalline powder. (slight halide-like odor, low volatility)
Purity97%+
StorageStore at 2-8°C, protect from light, keep sealed and dry
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
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)3.0
UV AbsorptionUV-absorbing
Halogen ContentF-containing
Nitrogen Atoms1

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