This proposal is based on the version of the chapter official as of December 1, 2020. Furthermore, revisions to the PDEs for nickel (inhalation), gold (oral, parenteral, inhalation), and silver (parenteral) have been made to correct calculation errors. The revisions are proposed to add permitted daily exposures (PDEs) for the cutaneous and transcutaneous route.
The chapter is being revised to align with ICH Q3D (R2) from the ICH Q3D Expert Working Group. Original Posting: 20–Jul–2010 Last Update: 17–Jan–2023 General Chapters and Related Information In the News: Read about the impact of Elemental Impurities on drug quality at our Quality Matters blog.
