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

Live Webinar July 23rd, 2020

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.

You can register for free to all our webinars and you will automatically receive the On-Demand version

More information

Details

Malvern WR14 1XZ, UK

Malvern Panalytical

Associated Trend items

Structure-based drug design: Selective WEE1 inhibitors

Despite many tremendous advances in cancer research over the last few decades, new treatments that further improve clinical outcomes and quality of life for patients are still highly sought after.

One class of small molecules that lead to many treatments now providing standard of care for cancer patients are kinase inhibitors. This target class contains over 500 members, many of which are undrugged. Protein kinase inhibitors are anticipated to deliver many more therapies to treat cancer and other diseases, such as fibrosis and rheumatoid arthritis. Small molecule...

More information

Biologics masterclass: immunotherapy discovery & development

Live webinar 28 June 2022

Immunotherapy is a powerful tool in the targeted treatment of a wide range of disease pathologies and the number of immunotherapy drugs in the discovery pipeline continues to grow. Immunotherapy approaches include switching off or restoring balance to aberrant immune responses (such as those seen in autoimmune disease or allergy) or switching on beneficial immune respons...

More information

Ask an Expert! Hints and tips for customizing your thin film analysis using XRD

Whether you have questions about samples or sample prep, setting up an experiment, or performing analysis, feel free to submit them so that we can deliver the information you require.

There’s always more to learn, whether it’s setting up your measurements for quick batch processing, gaining confidence in the quality of your results, or presenting your data in the best format. For this webinar, we’ll assume you’ve watched the previous one on the same topic. Don't worry if you missed it or can't remember it – you can watch it back here. Don’t forget ...

More information

Products associated

XRF spectrometer

Epsilon 1 pharma

XRF spectrometer

Zetium

Compare

Remove all

Compare up to 10 products