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Insights into Elemental Impurities

Elemental impurities in drug products are impurities that either are or contain certain chemical elements – most notably those elements identified as metals and transition metals. The ICH Harmonized Guideline Q3D, Guideline for Elemental Impurities (1), notes in its introduction that “because elemental impurities do not provide any therapeutic benefit to the patient, their levels in the drug product should be controlled within acceptable limits”. This is a logical observation, and the guideline (which applies to both new finished drug products and new drug products containing existing drug substances) presents a process for assessing and controlling elemental impurities. A related document, United States Pharmacopeia (USP) Monograph <232> Elemental Impurities – Limits (2), also specifies limits for the amounts of elemental impurities in drug products. Both have been aligned to provide a consistent position on safety requirements for elemental impurities.

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About the Author

Dennis Jenke

Dennis Jenke is Distinguished Scientist at Baxter Healthcare Corporation, USA.

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