Ibrutinib Impurity 23 CAS CATO-C4X-106423

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-106423
Molecular FormulaC32H34N12O
Molecular Weight602.69 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ibrutinib Impurity 23 CAS CATO-C4X-106423 chemical structure

Description

The assigned purity is verified by mass-balance and quantitative NMR (qNMR) approaches, with the expanded uncertainty reported at a 95% confidence level (k=2). Batch homogeneity and stability are independently assessed for every lot.

CATO supplies Ibrutinib Impurity 23 (CAS CATO-C4X-106423), a pharmacopoeial impurity reference standard (molecular formula C32H34N12O, MW 602.69 g/mol) used for the identification and quantification of trace impurities in APIs.

Ibrutinib Impurity 23 (C32H34N12O) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. Its physicochemical properties are representative of its class; 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).

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 FormulaC32H34N12O
Molecular Weight602.69 g/mol
Purity>95%
StorageStore at room temperature, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)22.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms12

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