ICH: Final Q3D (R2) Guideline on Elemental Impurities
ICH Q3D (R2) has reached Step 4 of the ICH-Process and will now be distributed to the Member States for implementation. The revision (R2) focused 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.
For more details please refer to the Guideline for elemental impurities Q3D (R2), which was adopted on 26 April 2022 by the Regulatory Members of the ICH.
Source:
ICH: Quality Guidelines
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