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This week Mike & Ashley review the standardized methods for elemental impurity analysis in pharmaceuticals: ICH Q3D, USP <232>, and USP <233>. ICH Q3D provides guidelines for testing up to 24 elements and emphasizes risk assessment but not detailed testing calculations; USP <232> sets elemental impurity limits; and USP <233> addresses sample preparation and analysis and relies on ICH Q3D concepts such as “J” concentrations (to be covered next week). They explain risk assessment factors (element, route of administration, intentional addition, and screened materials) and outline element classes. They also discuss sample types (APIs, drug products, excipients) and how early screening can reduce final testing needs.
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