Issue Date: September 14, 2022
Issued by: Center for Drug Evaluation and Research
Topic(s): ICH-Quality
Status: Final
Q3D(R2) – Guideline for Elemental Impurities: International Council for Harmonisation; Draft Guidance for Industry
Elemental impurities in drug products may arise from several sources; they may be residual catalysts that were added intentionally in synthesis or may be present as impurities (e.g., through interactions with processing equipment or container/closure systems or by being present in components of the drug product). Because elemental impurities do not provide any therapeutic benefit to the patient, their levels in the drug product should be controlled within acceptable limits.
Download the Guidance Document
