FDA Draft Guidance on Elemental Impurities in Drug Products


FDA issued new draft guidance on elemental impurities in drugs. The guidance is consistent with the ICH Q3D – Guideline for Elemental Impurities. The guidance also addresses USP General Chapters <232> Elemental Impurities – Limits and <233> Elemental Impurities – Procedures standards, which go into effect in 2018.

For more information: https://www.fda.gov/downloads/Drugs/Guidances/UCM509432.pdf