Gefitinib Impurity 23 HCl CAS CATO-C4X-111723

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-111723
Molecular FormulaC16H13ClFN3O2
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gefitinib Impurity 23 HCl CAS CATO-C4X-111723 chemical structure

Description

CATO supplies Gefitinib Impurity 23 HCl (CAS CATO-C4X-111723), a pharmacopoeial impurity reference standard (molecular formula C16H13ClFN3O2HCl, MW 370.20 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Gefitinib Impurity 23 HCl (C16H13ClFN3O2HCl) is characterized by a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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.

As a certified reference material (CRM), Gefitinib Impurity 23 HCl meets the metrological traceability requirements of ISO/IEC 17025 laboratories. Batch-to-batch consistency is monitored via control charts to guarantee comparable assigned values across lots.

Physical & Chemical Properties

Molecular FormulaC16H13ClFN3O2 HCl
Molecular Weight370.20 g/mol
AppearancePale yellow to 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 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)10.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentF/Cl-containing
Nitrogen Atoms3

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