Abstract: OBJECTIVE To analyze the synthetic route of azirsartan, determine the information of starting materials, intermediates, side reaction products and other related compounds, study the mutagenicity of related compounds, determine the limit of related compounds, and provide basis for the establishment of quality standards. METHODS The genotoxicity data of related compounds were determined by searching related databases, and the mutagenicity of impurities was predicted by using two kinds of quantitative structure-activity relationship software. The genotoxicity of related compounds was classified according to ICH M7 guidelines, and the limits of related compounds were determined according to relevant guidelines. RESULTS Among the 18 compounds screened, 11 were non-genotoxic and could be controlled as non-genotoxic impurities, while 7 compounds showed positive mutagenicity prediction results and needed to be controlled as genotoxic impurities. CONCLUSION In order to ensure the safety of drug use, the total impurities in the final product should not >0.5%, the maximum limit of single impurity should not >0.001 875% for related compounds with positive mutagenicity prediction results, and the maximum limit of single impurity for other related compounds should not >0.1%.