Gefitinib impurity 71 CAS CATO-C4X-111771

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-111771
Molecular FormulaC14H16N2O4
Molecular Weight276.29 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gefitinib impurity 71 CAS CATO-C4X-111771 chemical structure

Description

CATO manufactures Gefitinib impurity 71 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

CATO supplies Gefitinib impurity 71 (CAS CATO-C4X-111771), a pharmacopoeial impurity reference standard (molecular formula C14H16N2O4, MW 276.29 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C14H16N2O4, Gefitinib impurity 71 contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 276.29 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).

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 FormulaC14H16N2O4
Molecular Weight276.29 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
StorageStore at 2-8°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
Degree of Unsaturation (DBE)8.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms2

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