Dr. Christian Zeine
Ph.D, Senior Manager, Scientific Affairs EMEA
United States Pharmacopoeia
Switzerland
The presentation will give an overview about controlling impurities in chemically defined APIs and their dosage forms. The origin and classification of impurities will be discussed. Corresponding ICH/FDA guidelines like Q3A/B, Q6A and M7 will be touched as well, as will be methods helping to identify impurities. The USP approach to monitor impurities is described, including a discussion of existing USP standards and standards under development to support impurity testing. Finally, the Pharmaceutical Analytical Impurities will be introduced, a product line of impurities that together with official USP Reference Standards provide a comprehensive solution for research and analytical needs.
About the speaker:
Dr. Christian Zeine is senior manager in the Scientific Affairs Group for the EMEA region, with a focus on Small Molecules, USPs General Chapters and biologics. Dr. Zeine 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, Dr. Zeine 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, reference standards characterization and adjacent fields. Dr. Zeine 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.