Abstract：Elemental impurities affect the safety and efficacy of drugs, and the International Council for Harmonization of Drugs for Human Use (ICH) released the final version of Q3D(R2): Guiding Principles for Elemental Impurities in April 2022. In this paper, we analyze the elemental impurities in chemical APIs with reference to Q3D(R2), identify the possible elemental impurities from various potential sources, and discuss the control strategies of elemental impurities in each link from the production perspective, which provides new research ideas for the follow-up research on drug R&D, production, quality control and marketing changes.
王威. 化学原料药元素杂质控制策略探索与思考[J]. 哈尔滨医药, 2024, 44(3): 44-46.
Wang Wei. Exploration and Reflection on the strategy of Controlling Elemental Impurities In Chemical Raw Materials. journal1, 2024, 44(3): 44-46.
2024, Vol. 44 
