Sorafenib Impurity 16 CAS 1012058-78-4

Description

The occurrence of Sorafenib Impurity 16 is closely related to a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

CATO supplies Sorafenib Impurity 16 (CAS 1012058-78-4), a pharmacopoeial impurity reference standard (molecular formula C20H13ClF3N3O4, MW 451.78 g/mol) used for the identification and quantification of trace impurities in APIs.

The molecular framework of Sorafenib Impurity 16 (C20H13ClF3N3O4) is characterized by a flavonoid core, an amide group, a hydroxyl group, an ether linkage, fluorine/chlorine substitution. In reversed-phase chromatography, its retention is governed primarily by the protonation state of its nitrogen-containing groups, which provides a practical basis for HPLC-UV/DAD or LC-MS method development. 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.

CATO manufactures Sorafenib Impurity 16 under ISO 17034:2016 accreditation with dual CNAS and ANAB accreditation. Each batch is characterized by orthogonal methods and supplied with a full Certificate of Analysis (COA), ensuring metrological traceability.

Physical & Chemical Properties

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