Join USP to explore the latest approaches to organic impurity analysis and scientific solutions to support pharmaceutical quality, including regulatory expectations and practical applications of the USP Reference Standards.
Organic impurities remain a key challenge throughout the drug development lifecycle, compromising product quality, patient safety, and regulatory compliance. As such, their identification, monitoring and quantification is essential to quality control. Regulatory requirements for impurity analysis demand robust and stringent approaches, with the ICH guidelines providing a key framework for establishing appropriate standards.
To support the identification and control of organic impurities, USP provides Impurity Reference Standards for a wide range of drug products. These standards provide a recognised reference point for impurity assessment and quality control across the product lifecycle.
This webinar will provide a brief introduction and background to organic impurity analysis in drug substances and products, starting with exploring the ICH guidelines and subsequent guidance.
Register today through your free European Pharmaceutical Review membership.
Regulatory expectations will be discussed using publicly available case examples, including Complete Response Letters, which illustrate how insufficient information on organic impurities, including nitrosamines and extractables/leachables, has contributed to FDA requests for application resubmission or other action. These cases will also highlight key considerations when testing impurities and developing and validating analytical methods.
Finally, the webinar will explore solutions for impurities, considering how USP’s standards, reference materials and analytical methods can support robust impurity profiling. This will be followed by a Q&A session at the end of the webinar.
What you will learn:
- The role and importance of organic impurity control.
- ICH guidance for identifying and controlling organic impurities.
- FDA expectations and considerations on impurity testing and qualification.
- Real-world examples of the impacts and limitations of using non-compendial reference materials in impurity analysis.
- Understanding how USP solutions support reliable impurity testing.
Register today through your free European Pharmaceutical Review membership.
Christian Zeine is Senior Scientific Affairs Manager, EMEA, US Pharmacopeia
Christian 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. Christian 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, reference standards characterization 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. Christian earned his Ph.D. degree in Organosilicon Chemistry from the University of Muenster, Germany.
Is the panel discussion free?
Yes – there is no charge to watch the panel discussion, either live or on-demand.
When will the panel discussion take place?
The webinar will be taking place on 23rd September 2026 at 2pm (BST).
Can I watch it later?
The panel discussion will become available to watch on-demand shortly after the live webinar takes place.
What are the benefits of attending live?
You’ll be able to ask the speakers your questions, which will be answered live in the Q&A towards the end of the session.
How long will the panel discussion be?
This panel discussion will last up to an hour.
What do I need to watch this panel discussion?
All you need is a computer with an internet connection. We recommend using headphones if possible if you’re in an office environment.
