PQRI Elemental Impurity Interlaboratory Study Raw Data

<p>The pharmaceutical industry recently implemented a new paradign in drug product elemental impurity (EI) analysis in ICH Q3D Guidelines and USP General Chapters &lt;232&gt; and &lt;233&gt;, 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.</p> <p>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.</p>