Bureau Veritas offers heavy and other trace metals analysis in pharmaceutical drug products and dietary supplements of various types ranging from proteins and cytotoxic compounds to peptides and oligomers.
Health Canada and the Food and Drug Administration (FDA) require analysis of elemental impurities in drug products to demonstrate that they are safe for human consumption. Elemental impurities may be introduced through raw materials of drug components, excipients, residual catalysts, or through contact with manufacturing equipment or container closures.
Our ICP-MS technology allows for the analysis of over 70 elements, including heavy metals, metal catalysts and other trace elements. Utilizing ICP-MS, ICP-OES and microwave digestion sample preparation techniques, we are able to meet the requirements set out in the USP general chapters USP <232> and USP <233>.