Ibrutinib Impurity 92 CAS CATO-C4X-106492

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-106492
Molecular FormulaC25H23ClN6O2
Molecular Weight474.94 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ibrutinib Impurity 92 CAS CATO-C4X-106492 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 92 (CAS CATO-C4X-106492), a pharmacopoeial impurity reference standard (molecular formula C25H23ClN6O2, MW 474.94 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Ibrutinib Impurity 92 (C25H23ClN6O2) contains a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. The molecule exhibits a degree of unsaturation (DBE) of 17.0, corresponding to approximately 17 ring(s) or double-bond equivalent(s). With a molecular weight of 474.94 g/mol, it falls into the moderately-high-molecular-weight range. 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 FormulaC25H23ClN6O2
Molecular Weight474.94 g/mol
AppearancePale yellow to yellow crystalline powder. (slight halide-like odor)
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; Contains ester bond; hydrolyzes under strong alkaline conditions
Degree of Unsaturation (DBE)17.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms6

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