Limits for the amounts of elemental impurities in drug products are specified by the United States Pharmacopeia (USP) and the International Council for Harmonisation (ICH). These limits are detailed in USP General Chapter 232 and ICH Guideline for Elemental Impurities Q3D. Standards based on oral permitted daily exposures along with an internal standard are provided, as well as high and low level multi-element calibration standards, which allow for quantitative analysis through custom applications.

Additional custom standards are available and may be requested through our Inorganic Technical Service Department.