Ibrutinib Impurity 31 CAS CATO-C4X-106431

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-106431
Molecular FormulaC25H25ClN6O2
Molecular Weight476.96 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ibrutinib Impurity 31 CAS CATO-C4X-106431 chemical structure

Description

The occurrence of Ibrutinib Impurity 31 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Ibrutinib Impurity 31 (CAS CATO-C4X-106431) is a certified pharmaceutical impurity reference standard with the molecular formula C25H25ClN6O2 and a molecular weight of 476.96 g/mol.

The molecular framework of Ibrutinib Impurity 31 (C25H25ClN6O2) is characterized by a steroid core, an amide group, a hydroxyl group, an ether linkage, chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. Halogen substitution (F/Cl/Br/I) produces a distinctive isotope pattern in mass spectrometry, a valuable aid for qualitative confirmation.

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 manufactures Ibrutinib Impurity 31 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 FormulaC25H25ClN6O2
Molecular Weight476.96 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)16.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Halogen ContentCl-containing
Nitrogen Atoms6

Related Ibrutinib Standards

Recommended Standards

Why CATO?