Sensitive Impurity Quantitation in APIs and Excipients - The Versatile Power of HPLC-CAD

The gold standard for drug quality assessment is HPLC using reversed-phase (RP) column chromatography with aqueous buffers, acetonitrile, and/or methanol, typically combined with UV detection.

Many excipients and active pharmaceutical ingredients (APIs) lack chromophores, making them not suitable for identification and quantification by UV detection. In this situation, the near-universal Charged Aerosol Detector (CAD) is an excellent alternative capable of detecting almost all non-volatile compounds.

A key consideration is that the mobile phase composition, often determined by solid phase chemistry, can influence the CAD response. In addition to RP, chromatographers often apply ion pair chromatography (IPC), mixed mode (MMC), and hydrophilic interaction (HILIC) chromatography methods.

This webinar addresses how these separation modes affect CAD selectivity and sensitivity when analyzing the API purity, including amino acids, vigabatrin, ibandronate, atropine, and gabapentin, as well as excipients, e.g., fatty acids, PEGs, and polysorbates.

Key Learning Objectives:

• Explore on the critical yet increasingly complex challenge of impurity profiling of APIs and excipients in pharmaceutical analysis
• Review on enhancement of sensitivity in detection to uncover low-level impurities
• Discover examples for quality assurance by HPLC-CAD analysis

Who Should Attend

This webinar is ideal for pharmaceutical scientists and laboratory professionals involved in impurity analysis, method development, and quality assurance, including:

• Analytical scientists and chemists
• Pharmaceutical R&D and method development scientists
• Quality Control (QC) and Quality Assurance (QA) professionals
• Scientists working on API and excipient characterization
• Contract development and testing laboratories (CDMOs/CROs)
• HPLC users looking to expand their detection capabilities beyond conventional UV detection

Presenter: Ulrike Holzgrabe (Senior-Professor, Pharmaceutical and Medicinal Chemistry, University of Würzburg)

Ulrike Holzgrabe holds a diploma in Chemistry and an approbation in Pharmacy. After habilitation in Kiel she became a professor of Pharmaceutical Chemistry at the University of Bonn and from 1999 till 2022 she holds a chair of Pharmaceutical and Medicinal Chemistry in Würzburg. She served for some 25 years as an expert of the German pharmacopoeia commission (at BfArM) and for 18 years as an expert and president of two expert groups at the European Directorate of the Quality of Medicines and HealthCare (EDQM). She has published 500+ papers in the field of quality assurance of drugs and medicinal chemistry.

Presenter: Frank Steiner (Senior Scientific Strategy & Market Intelligence Manager, Thermo Fisher Scientific)

Frank Steiner is the Senior Manager of Product Applications and helps coordinate scientific collaborations at Thermo Fisher Scientific. He received his Ph.D. in Analytical Chemistry from Saarland University in Saarbrücken, Germany, and has published 30+ publications in refereed journals and 10+ textbook chapters on HPLC topics.

Presenter: Katherine Lovejoy (Application Chemist, Thermo Fisher Scientific)

Katherine Lovejoy is an Application Chemist at the Thermo Fisher HPLC factory site in Germany and has a PhD in Inorganic Chemistry from the Massachusetts Institute of Technology (MIT, USA). She has experience as a chemist reviewer at the FDA (USA) and a scientist at Los Alamos National Laboratory (USA).