Ibrutinib Impurity 65 CAS CATO-C4X-106465

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-106465
Molecular FormulaC29H30N6O4
Molecular Weight526.59 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ibrutinib Impurity 65 CAS CATO-C4X-106465 chemical structure

Description

The occurrence of Ibrutinib Impurity 65 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.

Ibrutinib Impurity 65 (CAS CATO-C4X-106465) is a certified pharmaceutical impurity reference standard with the molecular formula C29H30N6O4 and a molecular weight of 526.59 g/mol.

Ibrutinib Impurity 65 (C29H30N6O4) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. It is notably hygroscopic, the carboxyl group imparts weak acidity; these physicochemical properties determine the optimal preparation and storage of its standard solutions. Nitrogen-containing functional groups confer excellent ionization efficiency in positive-ion electrospray (ESI) mode, making the compound well suited to LC-MS/MS analysis.

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 FormulaC29H30N6O4
Molecular Weight526.59 g/mol
AppearancePale yellow to yellow crystalline powder
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
Degree of Unsaturation (DBE)18.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms6

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