As we approach the point at which new USP and ICH methodologies for assessing metal contamination come into effect, companies need to act now or risk being left behind.
This primer is intended to help pharmaceutical manufacturers and contract laboratories understand and implement new methodologies for the determination of elemental impurities in drugs, drug products and raw materials, as well as elemental contaminants in dietary supplements.
New methods and guidelines are coming from United States Pharmacopeia (USP) Chapters USP <232>, <233> and <2232>, and counterpart guidelines from International Conference on Harmonization (ICH), which are observed by the European Medicines Agency and referred to as ICH Q3D.
United States
