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"Turning Impurity Data Into Development Decisions"

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Impurity characterization is no longer just a regulatory requirement — it is a development decision-maker.

As molecules become more complex and timelines compress, teams are under pressure to rapidly determine whether an impurity represents a manageable risk, a process issue, or a program-level concern. The challenge is not simply detecting impurities, but identifying them with enough confidence to support CMC strategy, regulatory interactions, and development progression.

Access this valuable content on-demand today to examine key approaches being used across small-molecule and API programs to move from detection to confident understanding. We explore:

• Methods for identifying, isolating, and controlling unknown and trace-level impurities in complex API matrices
• Practical purification and HPLC strategies that help analytical and quality teams shorten investigations and reduce rework
• Case-based approaches to managing potential genotoxic impurities during process optimization
• Techniques for characterizing impurities in finished drug products
• How high-resolution 2D NMR supports confident structural confirmation and stronger data packages

These expert discussions provide applicable strategies to de-risk impurity control, strengthen regulatory readiness, and support informed CMC decision-making across development. View the on-demand webinars now!

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