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# Draft Guide on Cadmium Elemental Impurities Q3D
- URL: https://www.fdaweb.com/draft-guide-on-cadmium-elemental-impurities-q3d/
- Published: 2018-07-13T12:00:00.000Z
- Updated: 2026-09-15T00:19:12.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5141861

FDA has posted a [draft guide](https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM613410.pdf?ref=fdaweb.com) from the International Council for Harmonization on “Elemental Impurities Q3D(R1).” The document discusses cadmium and how it has been shown to be genotoxic, but not mutagenic and has been acknowledged as a human carcinogen. Also, positive associations have been observed between exposure to cadmium and cadmium compounds and cancer of the kidney and of the prostate, the guidance says. “A sensitive endpoint for oral exposure to cadmium and cadmium salts is renal toxicity,” it adds. “Skeletal and renal effects are observed at similar exposure levels and are a sensitive marker of cadmium exposure.”