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# Guide on Drug Product Elemental Impurities
- URL: https://www.fdaweb.com/guide-on-drug-product-elemental-impurities/
- Published: 2018-08-08T12:00:00.000Z
- Updated: 2026-09-15T00:24:39.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5142067

*Federal Register* notice: FDA has made available a final guidance entitled “Elemental Impurities in Drug Products.” The document provides recommendations on controlling elemental impurities consistent with recommendations in an International Council for Harmonization guidance for industry entitled “Q3D Elemental Impurities.” It is also intended to assist manufacturers on complying with U.S. Pharmacopeia-related impurity requirements. To view the notice, click [here](https://www.gpo.gov/fdsys/pkg/FR-2018-08-08/pdf/2018-16984.pdf?ref=fdaweb.com).