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| Exploration and Reflection on the strategy of Controlling Elemental Impurities In Chemical Raw Materials |
| Wang Wei |
| Harbin Pharmaceutical Group Pharmaceutical General Factory,Harbin 150086,China |
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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.
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Received: 05 March 2024
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2024, Vol. 44 
