Pharmaceutical Masterclass: Applying the Guidance in USP232 USP233 and ICH Q3D for Elemental Analysis

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Safe manufacture and supply of pharmaceutical products requires companies to ensure that patient exposure to toxic elements such as lead (Pb), mercury (Hg), arsenic (As) and cadmium (Cd) is controlled to within safe limits as part of their drug dosing regimens. In response to this need, the International Conference on Harmonization (ICH) issued guidance in ICH Q3D regarding the acceptable exposure limits for 24 potentially toxic elements within drug products designed for oral, parenteral and inhaled administration. Compendial guidance, such that that provided in United States Pharmacopeia (USP) chapters <232>and <233>, supports ICH Q3D and provides additional direction regarding the measurement procedures which can be applied to assess the presence and concentration of elemental impurities. Since 2018, it has been a requirement for all pharmaceutical companies supplying to the US market to comply with USP <232>and USP <233>. 

This webinar will be presented by Nancy Lewen, a recognized expert in element analysis who, over the past 15 years, has worked within with pharmaceutical industry and with groups considering methods standardization to understand how the requirements for elemental impurity detection can be realized. Nancy will explore the harmonization of USP <232>and ICH Q3D, along with the different analytical methods which can be used to measure elemental impurities in pharmaceutical products, intermediates and raw materials as described in USP <233>. Nancy will share her experience of following the ICH and USP requirements, including approaches for assessing the capability and application of the different elemental analysis methodologies. In particular, she will investigate the use of X-Ray Fluorescence (XRF), as compared to ICP and ICP-MS, focusing on its limitations and advantages for different drug products.


Guest Presented by: Nancy Lewen - Elemental Analysis Expert

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Who should attend? 

  • Those interested in the analysis of elemental impurities in pharmaceutical products and ingredients 
  • Those interested in drug safety and toxicology with regard to elemental impurities 
  • Anyone with an interest in method development for XRF as applied for USP <233>
  • Those considering XRF as an alternative to ICP or ICP-MS for the detection and quantitation of elemental impurities in drug products 

What will you learn?

  • Development and harmonization of USP <232>, USP <233>and ICH Q3D. 
  • Analytical methods used to detect and measure elemental impurities. 
  • Alternative analytical methods to ICP and ICP-MS – their limitations, advantages and disadvantages. 
  • Development of a risk-based method for analyzing elemental impurities. 
  • XRF method design. 
  • How XRF has been used for elemental impurity analysis in a pharmaceutical company.