Acalabrutinib Impurity 11 CAS CATO-C4X-305511

Purity 95%In StockPharmacopoeial Impurity Standards
CAS No.CATO-C4X-305511
Molecular FormulaC17H17N5O2
Molecular Weight323.35 g/mol
CategoryPharmacopoeial Impurity Standards / EP Impurities
AvailabilityIn Stock

Chemical Structure

Acalabrutinib Impurity 11 CAS CATO-C4X-305511 chemical structure

Description

Compared with other compounds in its class, the molecular weight of 323.35 g/mol gives Acalabrutinib Impurity 11 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

Acalabrutinib Impurity 11 (CAS CATO-C4X-305511) is a certified pharmaceutical impurity reference standard with the molecular formula C17H17N5O2 and a molecular weight of 323.35 g/mol.

Acalabrutinib Impurity 11 (C17H17N5O2) 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. 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.

As a certified reference material (CRM), Acalabrutinib Impurity 11 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 FormulaC17H17N5O2
Molecular Weight323.35 g/mol
AppearancePale yellow to yellow crystalline powder
Purity95%
StorageStore at 2-8°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)12.0
UV AbsorptionUV-absorbing
Structural FeaturesAromatic ring present
Nitrogen Atoms5

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