USP-Compliant Sample Preparation: Best Microwave Digestion Practices to Prepare Samples for ICP Analysis

Elemental impurities pose risks to pharmaceutical quality and efficacy, necessitating accurate and precise analysis within drug development and control. Since 2018, ICH Q3D guideline and USP <232> have imposed stringent limits for toxic elements like Cd, Pb, As, and Hg. USP <233> also requires robust sample preparation prior to ICP-OES or ICP-MS analysis. This webinar will discuss microwave-assisted closed vessel digestion as the ideal sample preparation method for compliant elemental analysis.

This webinar focuses on sample preparation for elemental impurity analysis in pharmaceuticals, including a survey of the regulatory background of ICH Q3D and USP <232>/<233>. It will provide an overview of sample preparation basics, with a particular emphasis on microwave-assisted acid digestion techniques.

Additionally, the session will discuss application examples covering a range of samples, from simpler to more complex substances such as tricyclic and tetracyclic compounds. 

Essential topics in relation to sample preparation of pharmaceutical products and raw materials for elemental impurity analysis:

• Regulatory framework overview, with a focus on ICH Q3D and USP <232>/<233> guidelines.
• Fundamentals of sample preparation, emphasizing microwave-assisted acid digestion techniques.
• Practical application examples ranging from simpler samples to highly challenging substances such as tricyclic and tetracyclic APIs.
• Analysis of elements including the "big four" (Hg, As, Cd, Pb) and how to achieve acceptable recovery rates, even for Os.

Who should attend?

• Lab chemists doing trace metal analysis of pharmaceuticals (raw materials and finished products) in R&D, QC or analytical contract labs
• Analytical chemists in state or municipal laboratories
• Laboratory managers of ICP and trace metal labs
• Academic chemists