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2 results for “Elemental Impurities”
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 <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.</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>
Assessment of Elemental Impurities Level After Multiple Administration of DWJ1230 or DWB2001 in Subjects With Functional Diarrhea or Irritable Bowel Syndrome With Predominant Diarrhea.
ClinicalTrials.gov study NCT05816681. IPD Sharing: Not stated. Countries: 1. Publications: 0.
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