Feasibility of wavelength dispersive X-ray fluorescence spectrometry for the determination of metal impurities in pharmaceutical products and dietary supplements in view of regulatory guidelines

Figueiredo, Alexandra; Fernandes, Tânia; Costa, Isabel Margarida; Gonçalves, Luísa; Brito, José

doi:10.1016/j.jpba.2016.01.028

Cited by 16 publications

(7 citation statements)

References 13 publications

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“…Because fully developed and verified metals-rich plant-based reference materials are not readily available, custom dried plant-based reference materials were prepared from easily obtainable commercial materials using methods similar to Figueiredo et al (2016). Sample preparation techniques were developed for quantitation via WD-XRF and portable ED-XRF spectroscopy using the custom dried plant-based reference materials.…”

Section: Methodsmentioning

confidence: 99%

“…Established methods for measuring elements in vegetable and herb tissues includes a combination of traditional wet chemistry methods such as atomic absorption spectrometry (AAS) (Bozym et al, 2015, Chopra and Pathak, 2015, Lima et al, 2009, Sekara et al, 2005, Song et al, 2012, Yadav et al, 2015), inductively coupled plasma-atomic emission spectrometry (ICP-AES) or inductively coupled plasma-mass spectrometry (ICP-MS) (Bešter et al, 2013, Finster et al, 2004, Murray et al, 2011, Nabulo et al, 2011, Rodriguez-Iruretagoiena et al, 2015, Wiseman et al, 2013), wavelength dispersive XRF (WD-XRF) (Andersen et al, 2013, Figueiredo et al, 2016), bench-mounted energy-dispersive XRF (ED-XRF) (Anjos et al, 2002, Gallardo et al, 2016, Jolly et al, 2013), and portable ED-XRF (Ferri et al, 2015, Gutiérrez-Ginés et al, 2013, Sacristan et al, 2016, Towett et al, 2016). Recent work quantified heavy metals in algae with portable ED-XRF using a fundamental parameter factory calibration for plastics (Bull et al, 2017, Turner et al, 2017).…”

Section: Introductionmentioning

confidence: 99%

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XRF techniques to quantify heavy metals in vegetables at low detection limits

2019

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Section: Methodsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

XRF techniques to quantify heavy metals in vegetables at low detection limits

2019

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“…An investigation of 7 branded, 23 generic drugs, and 25 dietary supplements was held. 13 One of the TXRF advantages should be highlighted separately. It is the opportunity to analyze liquid samples, solid samples, or their combinations, for example, suspensions.…”

Section: Introductionmentioning

confidence: 99%

“…DS can also be successfully analyzed by wavelength‐dispersive x‐ray fluorescence spectrometry. An investigation of 7 branded, 23 generic drugs, and 25 dietary supplements was held 13 …”

Section: Introductionmentioning

confidence: 99%

Quantification of elements in dietary supplements by total reflection x‐ray fluorescence and inductively coupled plasma optical emission spectrometry

Alov,

Danilov,

Sharanov

et al. 2023

X-Ray Spectrometry

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The main purpose of this study was the comparison of the results of quantification obtained via different sample preparation approaches such as microwave‐assisted wet digestion (MAWD) and suspension preparation. Two total reflection x‐ray fluorescence (TXRF) spectrometers equipped with Mo x‐ray tubes were used to compare results obtained via two different paths of sample preparations which would further be compared to the conventional way of analysis by inductively coupled plasma optical emission spectrometry (ICP‐OES) including MAWD. Three dietary supplement samples with different sets and concentrations of elements were analyzed. The benefits and limitations of the simplified path of sample preparation were highlighted. A round‐robin test between TXRF and ICP‐OES was discussed. Accuracy as the percentage of recovery in all measurements ranged from 80 to 120. Precision for all results did not exceed 8% for TXRF and 5% for ICP‐OES. Limits of quantification by TXRF are ranged from 1 to 0.01 mg/pill for different elements. It was shown that suspension preparation of samples might be a useful response to increasing demand for quality control of dietary supplements since it is less time consuming and cost efficient.

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“…However, the presence of other elements other than the aforementioned may also have adverse effects and potentially put product quality and consumer safety in jeopardy. As USP and European Medicines Agency (EMA) establish limits for several metal impurities in drug products [18,19] (Table 2), it was decided in this study to extend to food supplements the monitoring of Cr, Cu, Ir, Mn, Mo, Ni, Os, Pt, Rh and Ru, all with a validated analytical procedure [20]. Table 2.…”

Section: Introductionmentioning

confidence: 99%

Food Supplements for Weight Loss: Risk Assessment of Selected Impurities

et al. 2020

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Nowadays, food supplements are widely consumed, often without any medical supervision. In this study, 25 food supplements for weight loss, randomly purchased from five different suppliers in the European Union, were analysed by Wavelength Dispersive X ray Fluorescence spectrometry (WDXRF). The aim of this study was the risk assessment of trace elements and the mixture of elements present in food supplements for weight loss. The obtained Hazard Index (0.11) showed no potential risk of non-carcinogenic effects to human health. However, since humans are frequently exposed by different routes and/or sources to toxic metals, the additional consumption of these products may cause potential toxicological risks that cannot be ignored. In one analysed food supplement (FS), the simultaneous presence of Pb and Mn in high concentrations was detected. In two, FS chromium concentrations were above the reference daily dose. Unconformities were detected between the labelled and the detected values, which emphasises the misinformation of labels. This highlights the need for a deeper surveillance of food supplements.

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Feasibility of wavelength dispersive X-ray fluorescence spectrometry for the determination of metal impurities in pharmaceutical products and dietary supplements in view of regulatory guidelines

Cited by 16 publications

References 13 publications

XRF techniques to quantify heavy metals in vegetables at low detection limits

XRF techniques to quantify heavy metals in vegetables at low detection limits

Quantification of elements in dietary supplements by total reflection x‐ray fluorescence and inductively coupled plasma optical emission spectrometry

Food Supplements for Weight Loss: Risk Assessment of Selected Impurities

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