Ibrutinib Impurity 60 CAS CATO-C4X-106460

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-106460
Molecular FormulaC34H42N8O3
Molecular WeightN/A
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ibrutinib Impurity 60 CAS CATO-C4X-106460 chemical structure

Description

Owing to a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage, Ibrutinib Impurity 60 is typically pale yellow to yellow amorphous powder. Its solid-state physicochemical attributes — including a molecular weight of 610.76 g/mol — guide the selection of appropriate sample preparation and analytical techniques. The presence of an aromatic ring or conjugated system gives the compound characteristic absorption bands in the UV-Vis region, making it well suited to UV or diode-array detection (DAD).

As a process- or degradation-related impurity, Ibrutinib Impurity 60 (CAS CATO-C4X-106460, C34H42N8O3) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

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.

As a certified reference material (CRM), Ibrutinib Impurity 60 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.

Physical & Chemical Properties

Molecular FormulaC34H42N8O3
Molecular Weight610.76 g/mol
Purity97%+
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)18.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms8

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