Trace impurities in Pharmaceutical Products: Nitrosamines and beyond

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Webinar Date/Time: Monday, November 28 2022 at 11 am EDT

An informative presentation on the source and type of impurities seen in the pharmaceutical industry, how they are tracked and controlled. Regulatory and analytical aspects of determining mutagenic impurities, including nitrosamines, will also be consider.

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Event Overview:

Impurities, impurity profiling and analytical challenges of detection and quantification of trace level impurities in pharmaceutical products including mutagenic nitrosamine impurities will be presented. Risk assessment of mutagenic impurities and the difficulties in analysis from sample preparation through to detection will be considered. Current technologies used for trace impurity detection and quantification will be discussed and consideration given to new and emerging technologies. Topics include:

  • Impurities, potential impurities, and how they occur
  • Mutagenic impurities, regulations, and assessment of risk
  • Analytical challenges, selecting methods, and importance of sample preparation
  • New analytical technology for trace and ultratrace analysis

Key Learning Objectives:

  • What are impurities and where do they come from?
  • Alleviating the risk of impurity formation by better understanding of the active pharmaceutical ingredients, its source, and manufacturing process
  • The different types of technologies available for trace impurity analysis including the potential of vacuum UV

Who Should Attend:

  • Analytical and process chemists within the pharmaceutical industry


Richard Ladd
RML Consulting

Richard is a senior Leader and owner and Director of RML Consulting. An independent consultant to the pharmaceutical industry specialising in pharmaceutical development, manufacture, and new technology innovation. With more than 35 years Pharmaceutical industrial experience of all stages of new drug discovery, development, scale-up, manufacture, supply, and commercialisation.

Richard has an extensive track record of delivering in scientific, line, and project leadership roles across Pharmaceutical R&D, regulatory CMC, the analytical instrument industry and at the Interface of academia and the public sector. He has extensive expertise in analytical, pharmaceutical development and regulatory CMC authoring and reviewing regulatory submissions from first-in-human to NDA/MAA as well as defending regulatory submissions and conducting prep-approval audit inspections of both manufacturing and analytical facilities. In addition, he has a passion for new technology development and adoption and is an impeccable technical problem solver with a proven track record of solving many commercially significant problems.
Richard has extensive experience of the EU, US, China, Japan, India, and other emerging markets. He is highly active, networked and influential across an extensive portfolio of academic, industrial, healthcare, public sector, and policy related matters.

Richard is a lucid communicator who provides clarity on strategic direction and is tenacious and delivery-focused while challenging the status quo, affecting change, and driving improvement.

Richard regularly presents at international meetings most recently on the subjects supporting quality by design strategies with technology solutions in pharmaceuticals, technology adoption for technical trouble shooting and driving efficiency and productivity to shorten development times by utilizing novel technological solutions.

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