Watch these on-demand webinars to learn more.
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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