engleski

Determination of elemental impurities in active pharmaceuticals by single ICP-MS run after prior stabilisation of osmium

The aim of this study is to develop method for the analysis of elemental impurities (Li, V, Cr, Mn, Fe, Co, Ni, Cu, Zn, As, Se, Mo, Ru, Rh, Pd, Ag, Cd, Sn, Sb, Ba, Os, Ir, Pt, Au, Hg, Tl and Pb) in active pharmaceutical substances. Pharmaceutical active substance is considered to be a pharmaceutically active ingredient (API) or excipient. Elements which are covered by this method are typically used as process catalysts or reagents during the synthesis of pharmaceuticals but also we can find them in manufacturing equipment and piping, cleaning solvents and packaging. Their use can lead to residues in the final pharmaceutical active ingredients, and thus in the final product - a drug. Analysis of elemental impurities is performed at every stage of production process of API, including the analysis of intermediates and starting materials.

ICP-MS; Elemental impurities; osmium

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