USP232, USP233 and ICH Q3D - elemental impurities testing

In this masterclass, elemental analysis expert Nancy Lewen shares insights into using X-ray fluorescence (XRF) to streamline elemental impurity screening during pharmaceutical development. With new guidance from USP Chapters <232> and <233> and ICH Q3D, the presentation dives into the role of XRF as a compliant, efficient alternative to ICP spectroscopy.

Overcoming complex regulatory compliance standards

Nancy explains the strict USP Chapters <232> and <233> and ICH Q3D guidelines around elemental impurities, designed to protect patient safety worldwide. Traditionally, ICP-MS and ICP-OES are used, but these methods come with high costs and complex workflows. Nancy states, "When USP first introduced the concept of elemental impurities, we faced major obstacles, especially with ICP-based testing." This led her to explore XRF in pharma as a simpler, more cost-effective alternative that could still meet the industries rigorous compliance standards.

Why consider XRF for Pharmaceutical workflows?

Nancy outlines key advantages that make XRF ideal for pharmaceutical screening:

• Reduced costs: XRF eliminates the need for frequent maintenance and expensive reagents.
• Time efficiency: With minimal sample preparation, XRF delivers results in minutes, unlike the lengthy ICP processes, which takes hours - even days in some cases.
• Accessibility: XRF is user-friendly, enabling non-experts to perform accurate analyses without extensive training.

Integrating XRF in elemental impurities testing

Pharmaceutical companies need reliable methods for monitoring elemental impurities that fit into strict workflows without overwhelming lab resources. According to Nancy, "XRF offers an effective balance, meeting both the practical demands of drug development and stringent compliance requirements."

Real-World Applications of XRF

• Case Study 1: Efficient catalyst removal
  Explore a real-life case study where XRF helped streamline palladium removal in drug synthesis, meeting the permitted daily exposure (PDE) requirements without the delays typical of ICP methods.
  
  
• Case Study 2: Simplifying routine Compliance
  In another example, we learn how XRF was used to verify elemental purity in excipients, avoiding unnecessary retesting and allowing scientists to focus on more critical aspects of drug development.

Advantages of Using XRF Over ICP

So, what are the benefits of incorporating XRF into your workflows? According to our guest speaker they are three-fold:

1. Rapid analysis: Obtain actionable results in minutes.
2. Lower costs: XRF requires less maintenance and fewer consumables than ICP.
3. Ease of use: Minimal training required—making it ideal for both specialists and non-experts.

Conclusion

XRF is a powerful, cost-efficient alternative to ICP methods, delivering rapid and compliant elemental analysis for pharmaceutical teams. As Nancy notes, "With XRF, we’re able to meet regulatory standards efficiently and keep our focus on advancing drug development."

For more on XRF’s role in pharmaceutical compliance, watch the full webinar or explore additional resources in our knowledge center.

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.