> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# ICH Guide on Elemental Impurities
- URL: https://www.fdaweb.com/ich-guide-on-elemental-impurities/
- Published: 2022-09-16T12:00:00.000Z
- Updated: 2026-09-14T17:59:37.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5152762

*Federal Register* notice: FDA is making available a final guidance entitled “Q3D(R2) Guideline for Elemental Impurities.” The International Council for Harmonization document provides recommendations for acceptable amounts of the listed elemental impurities for pharmaceutical products, and conducting risk assessments. To view the notice, click [here](https://www.govinfo.gov/content/pkg/FR-2022-09-15/pdf/2022-19997.pdf?ref=fdaweb.com).