Article: Elemental impurities: certified reference materials for ICH Q3D, USP<232> & <2232> and Ph.Eur. 5.20

Metallic contamination in drug products, referred to as elemental impurities, may arise from several sources.

They may be added intentionally in synthesis, or may be present as contaminants, (e.g., through interactions with processing equipment or by being present in components of the drug product) and are consequently detectable in the drug product. Since elemental impurities pose a risk to patient health due to toxicological effects, element impurity levels should be controlled within acceptable limits in the drug product.

Evolution of ICH Q3D guidelines

In 2009 the International Conference on Harmonization (ICH) proposed the development of a new harmonized guideline to provide a global policy for limiting metal impurities in drug products and ingredients.

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