From Concept to Medicine - A Comprehensive Drug Development Journey

164 - Strategic Approaches to Impurity Control in Multi-Step Organic Syntheses (S11E14)


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This episode explores the common sources of impurities in complex organic syntheses for drug development. What analytic techniques and process controls are implemented is gone over. There is a deep dive on all the ways impurities can take form. Materials that can cause it and other things that can stop the final solution.

Where they have a focus. Techniques to find and measure them is highlighted, such as ways to keep tabs on everything. Where that's all leading too, different regulatory standards and what happens is explained. A discussion on analytical testing follows in short order.

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From Concept to Medicine - A Comprehensive Drug Development JourneyBy Jim Mitchell

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