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ICH Guidance on Elemental Impurities for Drugs


Federal Register Notice: FDA is making available a guidance entitled Q3D Elemental Impurities, prepared under the auspices of the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use. It establishes permitted daily exposures for 24 elements in drug products based on evaluation of toxicity data. Permitted daily exposures are provided for each element by three routes of administration — oral, parenteral and inhalation. The guidance also provides for a risk-based approach to assessing the likelihood that elemental impurities with established permitted daily exposures will be present in a pharmaceutical product. To download this guidance, click here. To view this notice, click here.