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From Concept to Medicine – A Comprehensive Drug Development Journey

129 - Case Study: Tackling Complex Impurities (S9E9)

13 min • 10 maj 2025

Delve into a case study that walks through identifying, characterizing, and mitigating complex impurities with advanced analytical tools. Take a look at collaborative methods, and the importance of this collaborative work to ensure effectiveness. Hear how teams use chemistry, data, analysis, and more to understand exactly what is happening and what, if any, dangers they may pose to a consumer. Explore the processes used by analytical chemists to be impurity detectives as they test new medicines.

Gain perspective into analytical techniques and technologies such as mass spectrometry, NMR and much more, and how new products rely on the methods. Gain knowledge of what needs to occur during analysis and where regulatory processes fit into helping find and discover the impurities. See what takes place once a decision is ultimately made to find what is sent to the FDA to be reviewed and all that comes with it. Explore the importance of always trying to get a better end result.

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