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X-Ray Fluorescence Instruments and ICP-OES Analyzers for the Elemental Analysis of Pharmaceuticals

Application Briefs and White Paper

The U.S. Food and Drug Administration (FDA) within the framework of the pharmacopeia conferences together with the International Committee for Harmonization (ICH) has developed new methods for the analysis of inorganic contamination in pharmaceuticals and their components. The current USP method, <231> “Heavy metal limit test,” was recognized as insufficient and was replaced with two new chapters: USP <232> describes the maximum permitted quantity of metals and heavy metals in pharmaceuticals and raw materials; <233> the procedures for elemental analysis using ICP-OES and MS.

ICP-OES spectrometers like the SPECTROGREEN and SPECTRO ARCOS are excellently suited to applications in the pharmaceutical industry. With the lowest of detection limits, ICP-OES offers the required performance. This technology is easy to automate, the instrument software meets all expectations regarding traceability.

Energy dispersive X-ray fluorescence spectrometry (ED-XRF) is frequently utilized in pharmaceutical applications to conduct analyses according to relevant requirements. Here, the SPECTRO XEPOS convinces with its excellent detection limits, analytical sensitivity, and precision. It is also possible to perform rapid screening analyses for all relevant elements from Na to U to obtain additional information about the given sample. The simple sample preparation is a further advantage to XRF in the pharmaceutical industry together with the low risk of contamination during the analysis.