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Outlook for the Development and Management of Drug Impurities

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Impurity research is an important part of drug development. It includes selecting appropriate analytical methods, accurately distinguishing and measuring the content of impurities, and comprehensively determining the reasonable limits of impurities based on the results of pharmaceutical, toxicological and clinical research. This research runs through the entire process of drug development.

Since the large-scale recall of sartan drugs due to nitrosamine impurity contamination occurred in 2018, the regulatory authorities have significantly increased the control of potential carcinogens of nitrosamines. EMA and CMDh are also constantly updating the regulatory policy of nitrosamine impurities on the “What’s New” page of their official website, providing guidance on the latest regulatory policies to pharmaceutical manufacturers and CDMOs, reflecting the latest knowledge and policy adjustments.

China has gone through a process from extensive to strict management of pharmaceutical impurities, and the research has also risen to a very high level. Some experts, such as Mr. Xie Mufeng, even believe that there is a general situation of excessive research on impurities in the industry in my country today, thinking that the deeper the research , the more the number of impurities (the list of impurities is even full of 26 English letters; chiral isomer impurities are as high as more than 10, etc.) and the higher the requirements for quality standards, the better.