This application note shows that the compact Revontium™ XRF spectrometer provides repeatable quantitation of 20 heavy metals in pressed powders at levels below those specified in ICH Q3D for a 10 g daily dose.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) stipulates the use of instrumental methods to test for heavy metals in pharmaceuticals and their precursors, and this shift away from the use of wet chemical and colorimetric tests is now also reflected in the United States Pharmacopeia (USP).
Energy-dispersive X-ray fluorescence spectrometry (XRF) is one such instrumental method, which is suitable for screening oral solid drug products for elemental impurities, as outlined in ICH guideline Q3D. Although XRF is not formally ‘recommended’ in the corresponding USP chapter (USP<233>), any analytical method is acceptable provided that it meets the performance requirements. It should be noted that the elements and limiting concentrations required by the USP (as stipulated in USP<232>) are fully aligned with ICH Q3D, and that validation protocols applicable to the use of XRF for pharmaceuticals are provided in USP<735>.
In contrast to other methodologies for trace heavy metal analysis, and especially ICP-MS, energy-dispersive XRF has the advantages of being cost-effective and robust, making it an appealing technique for routine pharmaceutical testing. In this application note, we demonstrate the use of Revontium™, a compact XRF spectrometer, to analyze 20 trace-level heavy metals in Malvern Panalytical’s cellulose standards, and show that it meets the requirements of ICH Q3D.
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This application note shows that the compact Revontium™ XRF spectrometer provides repeatable quantitation of 20 heavy metals in pressed powders at levels below those specified in ICH Q3D for a 10 g daily dose.
The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) stipulates the use of instrumental methods to test for heavy metals in pharmaceuticals and their precursors, and this shift away from the use of wet chemical and colorimetric tests is now also reflected in the United States Pharmacopeia (USP).
Energy-dispersive X-ray fluorescence spectrometry (XRF) is one such instrumental method, which is suitable for screening oral solid drug products for elemental impurities, as outlined in ICH guideline Q3D. Although XRF is not formally ‘recommended’ in the corresponding USP chapter (USP<233>), any analytical method is acceptable provided that it meets the performance requirements. It should be noted that the elements and limiting concentrations required by the USP (as stipulated in USP<232>) are fully aligned with ICH Q3D, and that validation protocols applicable to the use of XRF for pharmaceuticals are provided in USP<735>.
In contrast to other methodologies for trace heavy metal analysis, and especially ICP-MS, energy-dispersive XRF has the advantages of being cost-effective and robust, making it an appealing technique for routine pharmaceutical testing. In this application note, we demonstrate the use of Revontium™, a compact XRF spectrometer, to analyze 20 trace-level heavy metals in Malvern Panalytical’s cellulose standards, and show that it meets the requirements of ICH Q3D.
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