How Reliable Are Your Impurity Results? Impurity Testing: Build Confidence and Reduce Risk with USP Standards.

Why impurity testing matters

Impurities may be introduced during formulation, manufacturing, packaging, or storage. They can compromise product quality, patient safety, regulatory approval and compliance, and time to market. Understanding, identifying, and controlling impurities is therefore more important than ever.

This webinar will cover:

• The evolving landscape of impurities – different types of organic impurities and their sources
• Key guidelines, quality considerations, and the USP framework
• Challenges and limitations of impurity reference materials available in the market
• Nitrosamines, extractables and leachables (E&L), and USP's impurities solutions developed to deliver accuracy, efficiency and compliance
• Learn more about USP science-based standards and resources for controlling impurities

Who should attend 

Professionals working in method development, analytical sciences, quality control, or regulatory support.

Explore USP resources

Learn more about USP science-based standards and resources for controlling impurities.

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Speakers

Dr. Christian Zeine, Senior Manager Scientific Affairs, EMEA, United States Pharmacopeia

Christian Zeine joined USP in 2019 as Senior Manager in the Scientific Affairs Group for the EMEA region, with a focus on Small Molecules, USP’s General Chapters and Impurities. In his job, he collaborates with scientific experts and stakeholders and is responsible for protecting and growing USP’s scientific reputation in the region and globally. Before joining USP, Christian worked for seventeen years in the field of pharmaceutical reference standards with a focus on impurities, and before that in the IVD (In Vitro Diagnostic) industry. His scientific expertise includes impurity testing, characterization of reference standards and adjacent fields. Christian has published several articles and white papers on topics such as impurities, overview of (certified) reference materials and the use of reference standards in method development and validation. He earned his Ph.D. degree in Organosilicon Chemistry from the University of Muenster, Germany.

Dr. Freddi Philippart, Head of BioPharma Sales, Eurofins BioPharma Product Testing Germany

Freddi Philippart has more than 15 years of experience in the pharmaceutical industry. After completing his Ph.D. in Organic Chemistry at the University of Louvain, he worked for five years as a scientist at RWTH Aachen University within the Excellence Program “From Small to Large Molecules.” In 2013, he joined Eurofins BPT (formerly PHAST GmbH) as a Project Manager, including responsibility for dissolution testing activities. As PHAST became part of the Eurofins network, the organisation continuously expanded its analytical services and capabilities within a growing international laboratory network. Throughout his career at Eurofins, Freddi has held various leadership roles and has served as Head of Sales since 2018. He has extensive experience in supporting pharmaceutical clients with stability studies and analytical challenges related to drug product quality control. In his presentation, he will highlight the importance of dissolution testing and demonstrate the advantages of partnering with Eurofins for the development and execution of robust dissolution strategies.