Gefitinib Impurity 49 CAS 214472-41-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.214472-41-0
Molecular FormulaC16H24N2O5
Molecular Weight324.37 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Gefitinib Impurity 49 CAS 214472-41-0 chemical structure

Description

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Gefitinib Impurity 49 is typically off-white to pale yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 324.37 g/mol — guide the selection of appropriate sample preparation and analytical techniques. 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).

Gefitinib Impurity 49 (CAS 214472-41-0) is a certified pharmaceutical impurity reference standard with the molecular formula C16H24N2O5 and a molecular weight of 324.37 g/mol.

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 49 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 FormulaC16H24N2O5
Molecular Weight324.37 g/mol
AppearanceOff-white to pale 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)6.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)2018
Nitrogen Atoms2

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