Elemental Impurities in Pharmaceutical materials according to ICH and USP Chapters <232> and <233>

Chapter <232> and ICH Q3D specify maximum limits for the amount of elemental impurities permitted in drug products, drug substances, active ingredients and excipients. These impurities may be present naturally, derived from the production catalysts or introduced inadvertently through the manufacturing process, or they could be environmental contaminants in the pharmaceutical raw materials. When elemental impurities have the potential to be present, compliance to the specified levels is a requirement. Here we present a simple and effective method for routine preparation and analysis of pharmaceutical material according to ICH and USP 232 and 233.

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