Macitentan: An overview of its degradation products, process-related impurities, and in silico toxicity.

•The assessment of the toxicity of impurities is an essential regulatory requirement.•Thirty-five compounds related to macitentan were found reported in the literature.•The drug was found to be more susceptible to degradation in acidic media.•The types of process-related impurities were dependent on the synthesis route.•Five compounds have potential risk for mutagenicity and carcinogenicity.