Reducing relative response factor variation using a multidetector approach for extractables and leachables (E&L) analysis to mitigate the need for uncertainty factors.
Journal of Pharmaceutical and Biomedical Analysis(2020)
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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