How XRF can transform elemental analysis in pharma

Elemental analysis is a crucial step in pharmaceutical development. Get it wrong, and you risk a failed regulatory submission, a costly product recall, or even lost business.

But the most conventional elemental analysis method, inductively coupled plasma (ICP), comes with friction: lengthy sample preparation and complex, costly workflows that slow decision-making.

X-ray fluorescence (XRF) spectrometry offers a faster, simpler alternative that’s changing how pharmaceutical labs approach elemental analysis. Learn what it could do for your pharmaceutical workflow below.

XRF vs ICP: Same confidence, less friction

The appeal of XRF is speed without compromise. Compared with ICP, XRF delivers a more rapid and straightforward workflow:

• Sample preparation and measurement can be completed in under 30 minutes.
• Because XRF requires no acid digestion, it removes much of the hazardous chemistry that ICP relies on.
• A laboratory technician can perform XRF analysis with minimal training, which frees up specialist time and lowers day-to-day costs.

By removing much of the complexity and time delay associated with conventional methods, XRF lets teams improve lab productivity, make decisions faster, and shorten time-to-market.

None of these benefits come at the expense of analytical confidence, making XRF a credible option alongside, or in place of, ICP.

What are XRF’s real-world pharmaceutical applications?

XRF supports several pharmaceutical applications, including catalyst residue monitoring and wear metal detection, alongside broader elemental impurity screening. Its advantages hold up to the demands found across these applications.

Matrix-matching for trace nickel quantification

Take a difficult single-element measurement example: quantifying trace nickel in a starting material used in API synthesis containing 14.1 wt% chlorine, which would normally skew the result.

A matrix-matching method using the Epsilon 4 XRF spectrometer measured nickel down to 2.8 ppm: comfortably within International Council for Harmonisation’s Q3D guideline (ICH Q3D) limits. This demonstrates that XRF can resolve genuinely difficult matrix interference without the acid digestion or lengthy sample preparation ICP requires.

Full-panel screening of ICH Q3D-restricted elements

Then scaling up to a full panel: on the Revontium spectrometer, 20 regulated heavy metals – including cadmium, lead, arsenic, and mercury – were screened in a single 22-minute workflow.

Each metal’s detection limit fell comfortably below the concentration threshold ICH Q3D sets for a 10 g daily dose. The results agreed closely with ICP mass spectrometry reference values, and repeated 20 times over, the variation remained below 1% for nearly every element.

These examples show that XRF can manage precise measurements in challenging circumstances, delivering fast and reliable screenings across a range of metals.

How XRF could improve your lab’s efficiency: Join the discussion

If you want to see how XRF could fit into your own pharma workflow, our upcoming webinar is the place to start.

Register now: XRF in Pharma: Faster Elemental Analysis for Accelerated Drug Development and Manufacturing

Join us on October 20 at 16:00 CEST to hear our experts, Anoek Nijhuis-Nollen and Dr. Natalia Dadivanyan, discuss real-world pharmaceutical applications of XRF and where it fits alongside established methods.

Don’t let ICP bottlenecks slow your drug development. Join us to discover what XRF can do for you.