Elemental analysis is a cornerstone of pharmaceutical development and manufacturing, ensuring the quality, safety, and efficacy of drug substances and products.
By detecting contaminants and verifying purity, elemental analysis supports regulatory compliance and helps to safeguard public health.
Elemental analysis of pharmaceutical samples with XRF
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.
Discover our range of X-ray fluorescence spectrometers
卓上蛍光X線分析装置 イプシロン1
Epsilon 4
The challenges of ICP for elemental analysis
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
X-ray fluorescence (XRF): an alternative to ICP
EDXRF - エネルギー分散型蛍光X線
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.
What is X-Ray Fluorescence?
XRF - 蛍光X線分析とは?蛍光X線分析の原理について
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.
Key Advantages of XRF
- 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.
XRF instrument overview
Malvern Panalytical provides a range of X-ray fluorescence (XRF) technologies, each designed to meet specific analytical needs. Choosing the right XRF spectrometer for your application depends on factors like sample type, required sensitivity, and precision.
Epsilon 1 | Epsilon 4 | Revontium | |
---|---|---|---|
Overview | Get started | Automate for higher throughput | Automate; prepare your methods for QC and full regulatory compliance |
Sensitivity | ✔ | ✔✔ | ✔✔✔ |
Measurement time per sample | 10 minutes to analyze 5 elements | 45 minutes to analyze 20 elements according to ICH-Q3D | 30 minutes to analyze 20 elements according to ICH-Q3D |
Sample throughput (automation) | 1 | 10 | 32 |
Catalyst residue according to ICH Q3D guideline* | ✔ | ✔ | ✔ |
Detection of toxic elements according to ICH Q3D guideline* | -- | ✔
1 g daily dose* | ✔✔
10 g daily dose |
Detect wear elements (Cr, Mn, V, Ni, Cu) | ✔ | ✔ | ✔ |
Find out more | Discover Epsilon 1 | Discover Epsilon 4 | Discover Revontium |
*e.g. ‘Big 4’: Cd, Pb, As, Hg [big 4 or toxic 7] according to ICH Q3D guideline |
Our expertise
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.