Cabazitaxel Impurity 32 CAS CATO-C4X-111532

Description

Under current pharmacopoeial and regulatory frameworks, quality-control requirements for this class of reference material explicitly involve the control of targets including Cabazitaxel Impurity 32.

CATO supplies Cabazitaxel Impurity 32 (CAS CATO-C4X-111532), a pharmacopoeial impurity reference standard (molecular formula C45H56N2O15, MW 864.93 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Cabazitaxel Impurity 32 (C45H56N2O15) contains a nitrogen-containing heterocyclic scaffold, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 19.0, corresponding to approximately 19 ring(s) or double-bond equivalent(s). With a molecular weight of 864.93 g/mol, it falls into the high-molecular-weight range. 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.

As a certified reference material (CRM), Cabazitaxel Impurity 32 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

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