Introduction
What is X-ray Fluorescence (XRF), and how does it work?
XRF in pharmaceutical elemental analysis
Applications of XRF in pharmaceuticals
Advantages over traditional elemental analysis techniques
Challenges and considerations in XRF for pharmaceuticals
Future of XRF in pharmaceutical analysis
In summary
References
X-ray fluorescence (XRF) is a powerful analytical technique that provides benefits for several industries. This technique is used to analyze materials such as powders, solids, and liquids and can be used for both the quantitative and qualitative analysis of a material’s composition.1
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Introduction
Elemental analysis plays a crucial role in the pharmaceutical industry, allowing scientists to understand a material or compound’s elemental composition. It also provides key information on any impurities in a sample. Elemental analysis provides benefits for quality control, regulatory compliance, and safety.
The pharmaceutical industry needs robust elemental analysis techniques, and among the different approaches in the modern laboratory, X-ray fluorescence stands out as a particularly suitable advanced method. In short, XRF can satisfy the demands of the pharmaceutical industry for this purpose. This article will explore the advantages of X-ray fluorescence in pharmaceutical elemental analysis.
What is X-ray Fluorescence (XRF), and how does it work?
X-ray fluorescence uses X-rays to determine the elemental composition of a sample. In most cases, it is non-destructive, making it ideal for the study of materials in several industries and giving it distinct advantages over traditionally destructive analytical techniques. It is a widely-used fast characterization technique in laboratories worldwide and is particularly relevant for the pharma industry.2
X-rays are “fired” at a sample, with some passing through while the substance absorbs others under analysis. Low-energy electrons are “knocked out” and replaced by higher-energy level electrons, which are detected as fluorescent X-rays.
Wavelength Dispersive XRF and Energy Dispersive XRF are the two main methods used. While many sophisticated XRF instruments have been since the inception of XRF, all instruments have the same basic components, which are an X-ray tube, detector, and sample holder.
What Is XRF?
XRF in pharmaceutical elemental analysis
Many different analytical techniques can be employed in the lab to provide information on a sample’s elemental analysis, but not all methods are suitable for the pharmaceutical industry due to the specific needs of scientists developing new drugs and therapies.
XRF analysis has several strategic advantages for pharmaceutical elemental analysis. Firstly, samples require minimal preparation with no need for harsh chemicals and reagents and can be prepared in a fraction of the time needed by other analytical techniques. Moreover, operators require less extensive training to employ this technique in the lab.
XRF is also more affordable than other techniques, such as inductively coupled plasma (ICP) spectroscopy. Furthermore, XRF possesses high sensitivity and accuracy, making it an ideal, cost-effective choice for regulatory compliance needs. Rapid results can be produced, which is suitable for quality control in high-throughput pharma labs.
One of the main advantages of XRF lies in its (commonly) non-destructive nature. Sample integrity can be preserved after elemental analysis as they are not altered or destroyed by XRF instruments.3
Applications of XRF in pharmaceuticals
XRF is ideal for the rapid and safe analysis of pharmaceutical compounds, playing a key role in quality control and ensuring that drugs are safe and productive. It also helps pharma companies meet stringent regulatory compliance standards.
XRF is used for a few key applications in drug development and quality control testing in the pharma industry. Firstly, it is used for elemental impurity testing as it can detect and quantify trace elemental impurities in drugs.
Contamination is a serious issue in drug development, and detecting any impurities before a drug is sold to the public ensures safety and helps meet standards such as ICH Q3D.
It also helps scientists verify the elemental composition of raw materials, ensuring the purity and quality of ingredients.
Another key application of XRF in drug development is packaging and container analysis. Along with the drugs themselves, packaging and containers must meet stringent quality and safety standards, such as the lack of harmful toxic materials such as heavy metals.
By analyzing the elemental composition of packaging and containers, XRF gives pharma companies and the public confidence in their safety.
Advantages over traditional elemental analysis techniques
Traditional elemental analysis techniques, such as the aforementioned ICP spectroscopy and atomic absorption spectroscopy (AAS), are still commonly used in laboratories worldwide, including in the pharma industry.
However, these techniques suffer from some distinct drawbacks, which make XRF more suitable for the needs of elemental analysis in pharmaceutical development. One of the main drawbacks of both ICP and AAS spectroscopy is in sample preparation. These techniques require sample dissolution and large dilutions.
Both these methodologies are destructive. Additionally, sample preparation in these techniques can cause inaccuracies. XRF avoids both these issues with minimal sample preparation and high sensitivity and accuracy.
This produces reliable results. Additionally, XRF is more rapid than these techniques and makes “at-line” analysis (analysis at the production site) more feasible.
Moreover, XRF requires less re-calibration than traditional elemental analysis techniques, and operators require less training to use XRF equipment. These advantages make XRF a robust, reliable, and efficient option for pharma laboratories.4
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Challenges and considerations in XRF for pharmaceuticals
While X-ray fluorescence (XRF) is a powerful and reliable elemental analysis technique, it has some limitations. Its detection limits, while sensitive, may not be adequate for analyzing certain low-abundance elements compared to methods like ICP-MS. Additionally, XRF instruments have a high initial cost, which can make them less accessible to smaller labs or facilities with budget constraints.
Regulatory compliance and certification also present challenges, as the pharmaceutical industry is highly regulated, and XRF is not yet as widely adopted as more established analytical techniques.
Future of XRF in pharmaceutical analysis
XRF is gaining traction as a widely used technology for elemental analysis in the pharmaceutical industry. Advances in sensitivity, miniaturization, and software integration are enhancing its capabilities, and the availability of handheld, portable XRF instruments is making the technology more accessible than ever.
New regulations around quality control and safety are also shaping the tools used in pharmaceutical production. Additionally, the growing focus on green chemistry and sustainability makes XRF an ideal choice for pharma labs, thanks to its minimal sample preparation and reduced reliance on toxic reagents.4
In summary
X-ray fluorescence (XRF) is a powerful, non-destructive, rapid, and safe technique for elemental analysis in the pharmaceutical industry. It is widely used for quality control, detecting impurities, analyzing excipients and active pharmaceutical ingredients, and assessing packaging and containers.
Compared to traditional methods like ICP and AAS, XRF offers significant advantages, making it particularly well-suited for pharmaceutical applications. With advancements in technology and increasing emphasis on green chemistry, XRF is becoming an increasingly common analytical tool in pharmaceutical labs globally.
References
- Koul, A (2023) The Power of Analytical Technologies in Pharma and Biopharma Manufacturing [online] ThermoFisher Scientific. Available at: https://www.thermofisher.com/blog/behindthebench/the-power-of-analytical-technologies-in-pharma-and-biopharma-manufacturing/ (Accessed on 09 November 2024)
- Horiba Scientific (2024) What is X-ray Fluorescence (XRF) and how does XRF work? [online] Available at: https://www.horiba.com/int/scientific/technologies/energy-dispersive-x-ray-fluorescence-ed-xrf/what-is-x-ray-fluorescence-xrf/ (Accessed on 09 November 2024)
- Malvern Panalytical (2024) The strategic advantages of X-ray fluorescence for pharmaceutical elemental analysis [online] Available at: https://www.malvernpanalytical.com/en/learn/knowledge-center/whitepapers/wp240815-xrf-pharma-elemental-analysis (Accessed on 09 November 2024)
- Malvern Panalytical (2018) Comparison of elemental analysis techniques – advantages of XRF in comparison with ICP and AAS [online] Available at: https://www.malvernpanalytical.com/en/learn/knowledge-center/insights/comparison-of-elemental-analysis-techniques-advantages-of-xrf-in-comparison-with-icp-and-aas/ (Accessed on 09 November 2024)
Further Reading