USP 232 Oral Impurities Standards
Limits for the amounts of elemental impurities in drug products are specified by The United States Pharmocopeia (USP) and the International Conference on Harmonization (ICH). The following standards are based off these limits as detailed in USP General Chapter 232 and ICH Guideline for Elemental Impurities Q3D. Standards based on oral permitted daily exposures are provided along with an internal standard. High and low level multi-element calibration standards that allow quantitative analysis through custom applications will be available soon.