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# ICH Elemental Impurities Guideline Revisions
- URL: https://www.fdaweb.com/ich-elemental-impurities-guideline-revisions/
- Published: 2021-05-11T12:00:00.000Z
- Updated: 2026-09-14T16:58:18.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5149296

FDA has released for public comment changes proposed to Appendix 2 of the International Council for Harmonization Q3D(R2) *Guideline for Elemental Impurities*. The [document](https://www.fda.gov/regulatory-information/search-fda-guidance-documents/q3dr2-guideline-elemental-impurities?ref=fdaweb.com) says there are four extracts from the guideline appendices with proposed revisions.