Co-Sense for Impurities 液相層析儀應用系統 FDA 準則草案,「藥物物質和產品中的基因毒性和致癌雜質:推薦方法」(Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches) 規定了原料藥中遺傳毒性雜質的允許限值 。