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Elemental Impurities in Pharmaceutical Products – Analysis using an Energy-Dispersive X-ray Fluorescence Spectrometer
Elemental Impurities in Pharmaceutical Products – Analysis using an Energy-Dispersive X-ray Fluorescence Spectrometer
19 Oct 2015The analysis processes that are recommended in many pharmacopoeias for the determination of impurities can require complex sample preparation. They sometimes do not show very good reproducibility and have to be matched to the sample matrix. Energy-dispersive XRF conforms to the analysis processes described without the requirement of extensive sample preparation. Using optimized excitation and evaluation parameters, the technology provides detection limits that are sufficient for the analysis of most of the relevant elements. This application note demonstrates the analysis of elemental impurities in pharmaceutical products using an energy-dispersive x-ray fluorescence spectrometer.
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X-Ray Diffraction and SpectroscopyX-Ray diffraction & spectroscopy are used in material characterization to discern the structure and elemental composition of a sample. X-Ray diffractometers (XRD) are superior instruments in elucidating the dimensional atomic structure of crystalline materials, including powders, thin films and single crystals. For large unit cells or ordered macromolecules, consider small-angle X-ray scattering (SAXS). X-ray spectroscopic techniques include X-ray fluorescence (XRF) and X-ray photoelectron spectroscopy (XPS), both providing simple and accurate methods for determining the elemental composition of a material. Energy dispersive (EDXRF) and wavelength dispersive (WDXRF) XRF spectrometers are available, as well as handheld/portable devices. High-resolution, 3D microstructure characterization of materials can be achieved with X-ray microscopes combining sub-micron resolution imaging with 3D computed tomography. Find the best XRD and XRF spectrometers in our peer-reviewed product directory: compare products, check customer reviews and receive pricing direct from manufacturers.RegulatoryPharmaceutical regulations impact on all areas of drug development, manufacture and control and supply. Services are provided from the early stages of drug development and clinical trials through to dossier submission, approval and marketing. Regulatory also includes submission of analytical studies from the pharmaceutical product and safety. X-Ray FluorescenceX-ray fluorescence (XRF) is an analytical technique used to determine the elemental composition of materials. It is widely used in geology, materials science, and environmental testing for detecting heavy metals and other elements. Browse our peer-reviewed product directory to find the best XRF systems, compare products, check reviews, and get pricing directly from manufacturers.Trace Level ImpuritiesTrace level impurities refer to low concentrations of unwanted substances found in chemicals, pharmaceuticals, and other products. Detecting and removing these impurities is crucial for product safety and regulatory compliance. Explore trace impurity analysis tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.Elemental AnalysisElemental analysis involves determining the elemental composition of a sample, often used in environmental, pharmaceutical, and material sciences. Techniques like ICP-MS, X-ray fluorescence, and atomic absorption spectroscopy allow precise quantification of elements such as metals and nonmetals in complex matrices. Browse our peer-reviewed product directory to find the best elemental analysis tools, compare products, check reviews, and get pricing directly from manufacturers.SpectrometrySpectrometry is a technique used to measure the mass-to-charge ratio of ions. It provides valuable information about the composition, structure, and molecular weight of compounds. Used across a variety of fields, including chemistry, biology, and environmental science, spectrometry is essential for identifying substances, analyzing mixtures, and developing new products. Explore the best spectrometry tools in our peer-reviewed product directory; compare products, check reviews, and get pricing directly from manufacturers.PharmaceuticalsPharmaceuticals are medicinal drugs used in healthcare to diagnose, prevent, cure and treat illnesses. Pharmaceuticals that are excreted after use appear in wastewater and can have detrimental effects on the environment.ManufacturingManufacturing is the production of merchandise for use or sale using labor and machines, tools, chemical and biological processing, or formulation.