Ibrutinib Impurity 15 CAS 2213398-75-3

Purity >95%In StockPharmacopoeial Impurity Standards
CAS No.2213398-75-3
Molecular FormulaC18H15N5O
Molecular Weight317.34 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Ibrutinib Impurity 15 CAS 2213398-75-3 chemical structure

Description

As a certified reference material (CRM), Ibrutinib Impurity 15 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.

As a process- or degradation-related impurity, Ibrutinib Impurity 15 (CAS 2213398-75-3, C18H15N5O) is essential for impurity profiling, related-substances testing, and forced-degradation studies in pharmaceutical development.

Ibrutinib Impurity 15 (C18H15N5O) contains a steroid core, an amide group, a hydroxyl group, an ether linkage. Its physicochemical properties are representative of its class; these physicochemical properties determine the optimal preparation and storage of its standard solutions. 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 FormulaC18H15N5O
Molecular Weight317.34 g/mol
AppearancePale yellow to yellow crystalline powder
Purity>95%
StorageStore at 2-8°C, protect from light
Solubility (reference)Soluble in DMSO, DMF, methanol
StabilityLight-sensitive; avoid direct strong light
Degree of Unsaturation (DBE)14.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
CAS Registry Year (est.)1998
Nitrogen Atoms5

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