Analysis of impurities in pharmaceuticals using ion chromatography

This webinar highlights the importance of impurity testing in pharmaceuticals and how ion chromatography can provide excellent sensitivity and selectivity when testing for ionic impurities.

The management and control of pharmaceutical impurities is a matter of great concern and is an important part of drug development and regulatory assessment.

Current regulations and guidelines demand a comprehensive understanding of the impurity profile of pharmaceutical products, as their safety and quality can be impacted by these impurities.

The ICH quality guidelines ICH Q3A and Q3B address questions related to the regulation of impurities in the drug substance and drug product, whereas other ICH quality guidelines address specific types of impurities, such as residual solvents and mutagenic impurities.

This webinar explores the different kinds of impurities that may be present in pharmaceutical products and how ion chromatography (IC) is the analytical tool of choice to meet regulatory authorities’ requirements and in defining effective control strategies.

Learn how ion chromatography can help to automate impurities analysis workflows. Inline sample preparation techniques will also be discussed.

Key takeaways:

• Understand the origins of impurities in pharmaceuticals and why impurity profiling is important

• Gain insight into the regulations surrounding impurities analysis in pharmaceuticals

• Learn about how ion chromatography makes an ideal technique for the analysis of ionic impurities, offering enhanced sensitivity and selectivity, and helping to automate and simplify workflow.

Presenter: Daniel Pereira (Senior Scientist, Regulatory Affairs, Hovione)

Daniel Pereira has been an analytical scientist at Hovione since 2018 and is currently a Senior Scientist of the chemical characterisation team in the R&D Analytical Development Area. He has extensive expertise in the field of chemical characterisation techniques with focus in several chromatography techniques and in the development and optimisation of analytical methods following AQbD approach. Daniel holds a bachelor´s degree in Pharmacy from University of Rio de Janeiro, Brazil and a MSc in analytical chemistry form Minho University, Portugal.

Presenter: Linx Waclaski (IC Product Manager, Metrohm USA)

Linx Waclaski is the Product Manager for Ion Chromatography at Metrohm USA, in Riverview, Florida. He has years of experience in multiple chromatographic techniques, including ion chromatography, gas chromatography, liquid chromatography, and mass spectrometry, with extensive experience in R&D and applications development. He has an MS in Forensic Science and a BA in Biochemistry from Duquesne University in Pittsburgh, Pennsylvania, US.