Impurities in pharmaceutical products are facts of life, and efforts to understand their origins and safety thresholds take place at every step of the product development and commercial lifecycle. From degradants in drug substance, to matrix-related impurities in drug product, to contaminants introduced in manufacturing or packaging; impurities find their way into products by many means. Identifying their source, class, structure, analytical response, potential for toxicity, requires every tool the analytical chemist can bring to bear. In addition, recent regulatory changes have placed renewed focus on extractable and leachable impurities, stability studies, and elemental impurities – and these have created even more technical challenges for the industry.

Recent ICH/FDA guidance (e.g. Q11 for drug manufacture, or Q3D for elemental impurities) as well as upcoming USP/NF chapters on extractable and leachable impurities and elemental impurities shows that the regulatory landscape continues to change, and the burden of impurity control on drug manufacturers continues to grow. Newer technologies such as accurate mass measurement, tandem mass spectrometry, µHPLC and ICP-MS increase our capabilities; but they also increase our ability to observe (and thus our task to characterize) previously invisible components in products.

In this one day workshop conference you will learn the basic strategies and requirements for impurity identification, characterization, and control at different stages of product development, from R&D phase to commercialization. Related substance impurities and their characterization, drug substance and drug product stability, excipient-related impurities, extractable and leachable exogenous impurities, and elemental impurities will all be discussed in specific topic sections. Moreover, the techniques and basic methods discussed are applicable to non-pharma products that are also subject to quality standards; such as agricultural products, cosmetic treatments, natural plant therapeutics such as cannabis, and nutraceuticals.

Participants in this seminar will:

  • Understand the ICH guidance and USP regulations associated with product manufacture and impurities

  • Understand basic methodology for identifying related substance vs. exogenous impurities

  • Associate impurity characterization with the product development timeline in a phase-appropriate way

  • Learn how the development of a drug product from a drug substance can impact impurity profile and change the burden on the sponsor

  • Learn about newer analytical technologies and their impact on impurity study

  • Develop a holistic understanding of impurity management across the product development life cycle


Jeffrey P. Kiplinger, PhD, Founder and General Manager, Averica & VP Science and Innovation, Neopharm Labs


Diego A. Zurbriggen, Supervisor, Analytical Laboratory, West Pharmaceutical Services, Inc.


Steven Baertschi PhD, President, Baertschi Consulting, LLC


Kenneth C. Waterman, Ph.D. President, FreeThink Technologies, Inc.


Mathieu Fournier, MSc, Supervisor, Analytical R&D, Neopharm Labs


Conference Chair
Natasha Demberg, BSc, MSc , Vice President of Pharmaceutical Solutions, Neopharm Labs

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