PQRI Elemental Impurity Interlaboratory Study Raw Data

The pharmaceutical industry recently implemented a new paradign in drug product elemental impurity (EI) analysis in ICH Q3D Guidelines and USP General Chapters <232> and <233>, which allow for EI analysis by inductively coupled plasma-mass spectrometry (ICP-MS) and similar techniques. To date, there have been few systematic evaluations of laboratory performance on EI analysis in drug products due to a lack of standardized samples and ongoing efforts to adopt best practices. We organized an interlaboratory study to provide a data-driven way to address key technical challenges faced by laboratories during the implementation of EI regulations, including laboratory equipment, interference correction strategies, and the method of calculating the final concentrations.

The data contained in this file includes the analytical results and characteristics for all participant laboratories in a format readable and analyzable by R. A manuscript describing the analysis of this data is in preparation, with a target submission date of October 2021.