Understand how toxicological assessment supports safer, more confident impurity control.
Drug impurities can arise throughout pharmaceutical development, from manufacturing, storage and packaging interactions to residual solvents and elemental contaminants. As regulatory expectations continue to evolve, manufacturers need a clear and scientifically justified way to assess impurity risk, establish acceptable limits and support compliance across the product life cycle.
In this white paper, we explain how toxicological assessment helps translate impurity data into practical safety decisions. We explore key ICH impurity guidelines, outline approaches for evaluating genotoxic and non-genotoxic impurities, and show how risk-based assessment supports extractables and leachables studies, impurity qualification and cleaning validation.
What you will find in our white paper?
- How impurity risk is assessed across pharmaceutical developmentUnderstand the role of toxicological assessment in evaluating organic impurities, inorganic impurities and residual solvents as part of a structured risk-based approach.
- How regulatory guidance informs safety limitsLearn how current ICH guidelines, including Q3A, Q3B, Q3C, Q3D, Q3E and M7, support the derivation of scientifically justified limits for impurities and contaminants.
- How genotoxic and non-genotoxic impurities are evaluatedExplore the methods used to assess impurity risk, including PDE, AI, TTC and QSAR approaches, and how they are applied depending on the available data and toxicological profile.
- How toxicological assessment supports practical development decisionsSee how these approaches are applied in extractables and leachables studies, impurity qualification and cleaning validation to support safer products and stronger regulatory submissions.