Macitentan Impurity 35 CAS 441798-36-3

Description

The occurrence of Macitentan Impurity 35 is closely related to a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine/bromine substitution in its molecular formula, which determines its behaviour during synthesis, purification, or degradation.

Macitentan Impurity 35 (CAS 441798-36-3) is a certified pharmaceutical impurity reference standard with the molecular formula C19H20BrClN6O4S and a molecular weight of 543.82 g/mol.

The molecular framework of Macitentan Impurity 35 (C19H20BrClN6O4S) is characterized by a flavonoid core, an amide group, a sulfone group, a hydroxyl group, an ether linkage, chlorine/bromine 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 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.

CATO manufactures Macitentan Impurity 35 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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