Application Note: Elemental Impurities

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.

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

This approach should provide clear regulatory guidance on specification limits for elemental impurities worldwide and logically should have an impact on the work of the national regulatory bodies in having transparent and comparable results.