Neratinib Impurity 42 CAS 1201080-23-0

Description

Compared with other compounds in its class, the molecular weight of 282.25 g/mol gives Neratinib Impurity 42 distinctive chromatographic separation conditions and mass-spectrometry parameter settings.

CATO supplies Neratinib Impurity 42 (CAS 1201080-23-0), a pharmacopoeial impurity reference standard (molecular formula C12H14N2O6, MW 282.25 g/mol) used for the identification and quantification of trace impurities in APIs.

Structurally, Neratinib Impurity 42 (C12H14N2O6) contains an amino-acid-derived structure, an amide group, a hydroxyl group, an ether linkage. The molecule exhibits a degree of unsaturation (DBE) of 7.0, corresponding to approximately 7 ring(s) or double-bond equivalent(s). With a molecular weight of 282.25 g/mol, it falls into the medium-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), Neratinib Impurity 42 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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