Impurity Profile Characterization

Solving Problems That Matter - a Waters webinar series featuring USP speakers

Episode 5: Impurity Profile Characterization

Summary

Characterizing of a product’s impurity profile refers to the process of establishing the impurities and degradation products (both actual and potential) that are most likely to arise during the synthesis, purification, and storage of a drug substance and additionally during the manufacturing and storage of a drug product. This session will explore how LC with optical and mass detection can be employed for impurity profiling.

Key learning objectives:

• Understand the analytical challenges related to organic impurity profile characterization
• Learn about the benefits of adding mass detection

Who should attend:

GMP laboratory analysts and managers involved with organic impurity profile characterization

Presenter: Christian Zeine (US Pharmacopeia)

Presenter: Henry Foddy (Associate Scientist, Waters Corporation)

Henry is a Scientist in the Routine Mass Detection Team at Waters, working on applications to support Waters’ single quadrupole portfolio that span a variety of market segments. He has almost 3 years of experience with Waters, working previously in a food and environmental role support regulatory testing of Pesticides, PFAS, and Pyrrolizidine Alkaloids. Prior to joining Waters, Henry obtained an MSc in Neuroscience from King’s College London.

Moderated by: Isabelle Vu Trieu (Pharmaceutical Market Development Manager, Americas, Waters Corporation)

Isabelle is a business development professional dedicated to delivering benefits to analytical scientists in the life sciences industry. With over 20 years of experience in providing chromatography and mass spectrometry solutions, Isabelle is particularly interested in helping pharmaceutical scientists achieve the data quality and integrity needed to drive decisions for drug quality, safety and efficacy. Isabelle joined Waters in 2009 and currently manages the development of the pharmaceutical market in the Americas. She holds Masters’ degrees in Chemistry from Columbia University and the University Claude Bernard in Lyon, France as well as a Chemical Engineering degree from Ecole Supérieure de Chimie Physique Electronique in Lyon, France.