Impurity Testing: Definitions, Guidelines, Analytical Reference Materials and Technologies, and Other Considerations

Join Our Experts from the USP and Waters on a live webinar!

Discover the latest strategies for managing API impurities with insights from USP and Waters experts. Learn how USP approaches organic impurities in small molecules then explore how Waters modernizes impurity methods using advanced LC technologies combined with Empower Software.  Don’t miss this opportunity to combine regulatory guidance with cutting-edge solutions that drive compliance and innovation.

Key learning objectives

• Understand impurity fundamentals and regulatory expectations: Gain a high-level overview of impurity definitions, classifications, and global guidelines for small molecule APIs.
• Explore USP approaches to impurity analysis: Learn how USP Reference Standards (RS) and Potential Applicable Impurities (PAIs) support qualitative and quantitative assessments, illustrated through real-world case studies.
• Discover modern tools for impurity method optimization: See how Waters’ LC technologies, column chemistries, and Empower™ software enable modernization of USP impurity methods with enhanced data intelligence and compliance.

Who should attend

Pharmaceutical R&D and QC laboratory staff, Contract research and manufacturing organizations (CROs/CMOs), Regulatory affairs professionals

Presenter: Christian Zeine, Ph.D. (Sr Manager, Scientific Affairs, 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.

Presenter: Stephanie N. Harden, Ph.D. (Senior Manager, Small Molecule Core Solutions – LC/MS, Waters Corporation)

Stephanie Harden leads the Product Marketing and Scientific teams for Waters’ small molecule HPLC portfolio. With over 25 years of experience in product and segment marketing, she has a proven track record in strategic program development, cross-functional leadership, and market-driven innovation. Her work connects scientific insight with commercial strategy to drive customer-focused solutions and sustained business growth. Stephanie holds a PhD in Chemistry from the University of Bristol, UK.

Moderated by: Samuel Seal (Biopharma Market Development Manager, Waters Corporation)

Samuel Seal is a market development manager specializing in the biologics space. He loves LC and MS – especially on how this technology provides benefit and value.

Sam joined Waters in January of 2014 as a Sales Technical Support Specialist in the Irvine office/lab. As a TSS he performed demonstrations on various instruments, provided training for customers, often presented on technical information at varying events, and assisted with troubleshooting from Colorado to Los Angeles.

He previously worked at Pyxant Labs in Colorado Springs, CO where he gained extensive experience developing and validating methods for small/large molecules in bioanalytical assays, agricultural commodities, registration of pesticides, and worker exposure studies. He also has experience in column chromatography, sample extraction, sample clean-up, reporting and data management. Sam has hands on experience with running and maintaining various manufacturers' LC/MS/MS systems. Prior to Pyxant, Sam was a Laboratory Instructor at the University of Colorado at Colorado Springs where he earned his Bachelor of Arts in Biology and Bachelor of Arts in Chemistry.