Neratinib Impurity 44 CAS 1222172-50-0

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.1222172-50-0
Molecular FormulaC15H17N3O4
Molecular Weight303.31 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Neratinib Impurity 44 CAS 1222172-50-0 chemical structure

Description

As a certified reference material (CRM), Neratinib Impurity 44 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.

CATO supplies Neratinib Impurity 44 (CAS 1222172-50-0), a pharmacopoeial impurity reference standard (molecular formula C15H17N3O4, MW 303.31 g/mol) used for the identification and quantification of trace impurities in APIs.

Owing to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, Neratinib Impurity 44 is typically pale yellow to yellow crystalline powder. Its solid-state physicochemical attributes — including a molecular weight of 303.31 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

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 FormulaC15H17N3O4
Molecular Weight303.31 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)9.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1990
Nitrogen Atoms3

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