The analysis of metal impurities for pharmaceutical products such as harmful elements contained in the raw materials and residual catalysts in the manufacturing process is important for the risk assessment in actual large scale production.
Various guidelines and criteria of harmful elements in pharmaceutical products have been established. According to USP?232? of the United States Pharmacopoeia (USP), pharmaceutical products are classified based on toxicity levels. The European medicines agency (EMA) has set guidelines for the limit of residual metal elements. Recently, the international conference on harmonization of technical requirements for registration of pharmaceuticals for human use (ICH) has proposed safety standard guidelines for metal impurities (Q3D) for the purpose of quality assurance of pharmaceutical products.
ICP-MS and ICP-OES have been typically used for the elemental analysis of impurities, but XRF analysis has been increasingly attracting attention due to the ease of sample preparation.
In this article, trace element analysis in pharmaceutical samples using an EDXRF (Energy- Dispersive X-ray fluorescence) spectrometer NEX CG that has superior sensitivity compared to conventional EDX spectrometers is introduced.