Tucatinib Impurity 34 CAS CATO-C4X-260534

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-260534
Molecular FormulaC26H22N8O2
Molecular Weight478.51 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Tucatinib Impurity 34 CAS CATO-C4X-260534 chemical structure

Description

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 supplies Tucatinib Impurity 34 (CAS CATO-C4X-260534), a pharmacopoeial impurity reference standard (molecular formula C26H22N8O2, MW 478.51 g/mol) used for the identification and quantification of trace impurities in APIs.

Tucatinib Impurity 34 (C26H22N8O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. The aromatic system may exhibit native fluorescence, enabling detection with a fluorescence detector (FLD).

CATO manufactures Tucatinib Impurity 34 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 FormulaC26H22N8O2
Molecular Weight478.51 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
StorageStore in a cool place (≤25°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)20.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms8

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