Gefitinib Impurity 46 CAS 2106-49-2

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.2106-49-2
Molecular FormulaC6H3ClFNO2
Molecular Weight175.54 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gefitinib Impurity 46 CAS 2106-49-2 chemical structure

Description

The occurrence of Gefitinib Impurity 46 is closely related to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution, an aromatic ring system in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Gefitinib Impurity 46 (CAS 2106-49-2), a pharmacopoeial impurity reference standard (molecular formula C6H3ClFNO2, MW 175.54 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to an amide group, a carboxylic acid group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution, an aromatic ring system, Gefitinib Impurity 46 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 175.54 g/mol — guide the selection of appropriate sample preparation and analytical techniques. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 manufactures Gefitinib Impurity 46 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.

Physical & Chemical Properties

Molecular FormulaC6H3ClFNO2
Molecular Weight175.54 g/mol
AppearanceOff-white to pale yellow crystalline powder. (slight halide-like odor, faint amine-like odor, low volatility)
Purity>95%
StorageStore at 2-8°C, protect from light, keep tightly closed to prevent evaporation
Solubility (reference)Soluble in methanol, acetonitrile, DMSO, water (slightly soluble)
StabilityMay oxidize slowly on prolonged air exposure; Light-sensitive; avoid direct strong light; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)5.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1957
Halogen ContentF/Cl-containing
Nitrogen Atoms1

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