ICH Q3E

ICH Q3E

Why Leachables Assessment May Need to Continue Through Pharmaceutical Stability Studies

Why Leachables Assessment May Need to Continue Through Pharmaceutical Stability Studies

A container-closure system may appear chemically compatible with a drug product at the beginning of shelf life. That does not necessarily mean the leachables profile will remain unchanged months or years later. Leachables can migrate from packaging, delivery systems, manufacturing-contact materials, or other product-contact components into a pharmaceutical product over time. Their formation and accumulation […]
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Understanding Analytical Evaluation Thresholds in Extractables and Leachables Studies

Understanding Analytical Evaluation Thresholds in Extractables and Leachables Studies

Extractables and leachables (E&L) studies can generate dozens—or even hundreds—of chromatographic peaks. But not every detected compound presents the same potential safety concern, and attempting to identify and quantify every analytical signal regardless of exposure would make many E&L programs unnecessarily complex. This is where the Analytical Evaluation Threshold (AET) becomes important. The AET provides […]
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