Digestion of Pharmaceuticals for Elemental Impurities Analysis with ICP-MS according to ICH Q3D, USP, and Ph. Eur. 5.20
The consideration of elemental impurities is mandatory for all pharmaceutical products since January 2018. Multiwave 5000 offers powerful options for sample preparation under full GMP compliance covering the huge variety of different drug formulations.
Since elemental impurities constitute not only a toxicological risk for the patient but also may affect the quality and efficacy of pharmaceutical products, their analysis plays an important role within the development and quality control of pharmaceuticals.
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