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Revised ICH Q3D (R2) Guideline on elemental impurities

ICH Harmonised Guideline for elemental impurities Q3D (R2) was adopted on 26th of April 2022 by the Regulatory Members of the ICH and will now be distributed to the Member States for implementation. The revision focuses on the establishment of limits for elemental impurities by the dermal route of exposure, summarized in a new Appendix 5 Limits for elemental impurities by the cutaneous and transcutaneous route and error corrections of the PDEs for Silver (oral), Gold (oral, parenteral and inhalation) and Nickel (inhalation).

The newly established PDEs:

  • the corrected parenteral PDE for Silver is 15 μg/day.
  • the corrected PDE of Gold by oral, parenteral or inhalation routes is identified as 300, 300, 3 μg/day.
  • the corrected PDE of Nickel by inhalation is now listed with 6 μg/day.