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Reducing relative response factor variation using a multidetector approach for extractables and leachables (E&L) analysis to mitigate the need for uncertainty factors.

Mark Anderson Jordi,Kevin Rowland, Weixi Liu,Xingluan Cao, Jie Zong,Yuan Ren, Zhu Liang,Xiao Zhou, Michael Louis, Kaitlin Lerner

Journal of Pharmaceutical and Biomedical Analysis(2020)

Cited 10|Views4
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Abstract
•217 extractables analyzed to measure the response factor variation on 6 detectors.•Multidetector strategy successfully mitigated quantitative error for 91% of compounds.•Multidetector strategy detected 94% of the compounds at the AET using a UF of 2.•Results contrasted with current industry practice and use of response factor databases.
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Key words
Extractables,Leachables,E&L,Uncertainty factor,Analytical evaluation threshold,Response factor database
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