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ZENODO
Dataset . 2021
License: CC BY
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ZENODO
Dataset . 2021
License: CC BY
Data sources: Datacite
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PQRI Elemental Impurity Interlaboratory Study Raw Data

Authors: Harrington, James; Seibert, Donna; Erickson, Stephen;

PQRI Elemental Impurity Interlaboratory Study Raw Data

Abstract

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.

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Keywords

Interlaboratory study, Elemental Impurities, Method development, USP 232/233

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selected citations
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This is an alternative to the "Influence" indicator, which also reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Citations provided by BIP!
popularity
This indicator reflects the "current" impact/attention (the "hype") of an article in the research community at large, based on the underlying citation network.
BIP!Popularity provided by BIP!
influence
This indicator reflects the overall/total impact of an article in the research community at large, based on the underlying citation network (diachronically).
BIP!Influence provided by BIP!
impulse
This indicator reflects the initial momentum of an article directly after its publication, based on the underlying citation network.
BIP!Impulse provided by BIP!
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