The ICH Q3D guideline is intended to control elemental impurities and establishes PDE (Permitted Daily Exposure) values for 24 elements. These apply to medicinal products that can be ingested orally, parenterally and via inhalation.
In revision Q3D(R2), the newly added Appendix 5 also defines limits for impurities in medicinal products that are absorbed cutaneously or transdermally. A basic approach based on a modifying factor (Cutaneous PDE) is presented.
The PDE values for the following elements in Appendix 2 have been corrected:
This also results in new values for the permitted concentration in µg/g for the respective elements. They are to be used when the content of elemental impurities in medicinal products does not exceed the daily dose of 10 grams per day.
Furthermore, the monographs for gold and silver in Appendix 3 have been adjusted.
The draft document is now available for public consultation. The ICH has focused on extracts of the passages that have been revised:
All proposed changes are marked in red letters.
The ICH has prepared a summarizing presentation for all changes, which provides a good overview.