XRF for pharmaceutical development

Offering a blend of speed, accuracy, and efficiency, XRF analysis is helping pharmaceutical companies BIG and small to enhance processes, optimize workflows, reach their sustainability goals, and get their products to market faster. 

Currently, ICP-OES and ICP-MS are the go-to solutions for elemental analysis in the pharmaceutical industry. However, there are many challenges associated with ICP:

• The lead time from sample preparation to result can be days or even weeks
• Sample preparation is time consuming, taking up to 48 hours in some cases
• Powder samples must be digested into liquids, which can require strong acids and microwaves, creating health and environmental risks
• It’s a labor-intensive technique: daily re-calibration is required for the elements of interest and requires highly specialized staff dedicated to method development and running the machine
• It requires dedicated infrastructure, such as fume hoods and extraction systems

Introducing energy-dispersive X-ray fluorescence (ED XRF) into your workflow will allow you to accelerate your drug development process and shorten route to market significantly. 

It’s fast and non-destructive, making it a robust screening solution for the elemental purity of drug substances, pharmaceutical intermediates, and final drug products. 

In fact, the versatility of ED XRF and its ease of use make it suitable for a wide range of drug development and manufacturing applications.

XRF is an atomic emission method, similar in this respect to optical emission spectroscopy (OES), ICP and neutron activation analysis (gamma spectroscopy). 

Such methods measure the wavelength and intensity of ‘light’ (X-rays in this case) emitted by energized atoms in the sample. 

In XRF, irradiation by a primary X-ray beam from an X-ray tube causes the emission of fluorescent X-rays with discrete energies characteristic of the elements present in the sample.

Speed and Efficiency

• Non-destructive: Analyzes samples without altering or destroying them, so you can comprehensively test the same sample, multiple times and using multiple techniques if necessary, saving both time and resources.
• Rapid results: XRF delivers accurate results fast, accelerating the development timeline and reducing costs. Samples can be prepared in as little as little as 2 minutes with high quality data delivered in under 30-minutes.

Accuracy and Sensitivity

• High precision: Detects trace amounts of elements with high accuracy. XRF achieves very low limits of quantification (LoQ) below the limits set in the ICH Q3D
• Broad elemental range: Capable of analyzing a wide range of elements, from sodium to uranium.

Ease-of-Use

• Minimal sample preparation: With XRF sample preparation is quick and easy, saving time, reducing the margin for operator error and simplifying analysis processes.
• User-Friendly: Operated with user-friendly software, XRF is accessible to both experts and non-experts alike.

With decades of experience in the field of pharmaceuticals, Malvern Panalytical has built a reputation for excellence. Our extensive portfolio of innovative instruments and technologies is designed to meet the complex needs of pharmaceutical research, development, and manufacturing.

We are committed to continuous innovation and maintaining the highest standards of quality. By investing in research and development, Malvern Panalytical consistently introduces cutting-edge solutions that address the evolving challenges in pharmaceuticals, including dissolution testing.

Find out more about how Revontium and Epsilon XRF Spectrometers can enhance your drug development workflow. To explore ED XRF applications in more details, contact us today. Our experts are ready to provide you with detailed information, demonstrations, and tailored solutions to meet your needs.