Ibrutinib Impurity 8 CAS CATO-C4X-10648

Purity 97%+In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-10648
Molecular FormulaC25H26N6O2
Molecular Weight442.51 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ibrutinib Impurity 8 CAS CATO-C4X-10648 chemical structure

Description

The occurrence of Ibrutinib Impurity 8 is closely related to a steroid core, an amide group, a hydroxyl group, an ether linkage in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Ibrutinib Impurity 8 (CAS CATO-C4X-10648), a pharmacopoeial impurity reference standard (molecular formula C25H26N6O2, MW 442.51 g/mol) used for the identification and quantification of trace impurities in APIs.

Based on its molecular formula C25H26N6O2, Ibrutinib Impurity 8 contains a steroid core, an amide group, a hydroxyl group, an ether linkage; these features give the compound characteristic absorption bands in UV spectroscopy. The molecular weight of 442.51 g/mol is directly relevant to the identification of the molecular ion in mass spectrometry. 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).

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.

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.

Physical & Chemical Properties

Molecular FormulaC25H26N6O2
Molecular Weight442.51 g/mol
AppearancePale yellow to yellow crystalline powder
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)16.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms6

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