Qualification of a Gas Chromatography/Mass Spectrometry (GC/MS)  Semi-quantitative Screening Method used for Analysis of Extractables and Leachables from Medical Devices, Medical Device Componentry and Other Associated Materials

Name: Qualification of a Gas Chromatography/Mass Spectrometry (GC/MS) Semi-quantitative Screening Method used for Analysis of Extractables and Leachables from Medical Devices, Medical Device Componentry and Other Associated Materials
Creator: Alan Hendricker
Published: 2022-12-15T08:12:32.950Z
Keywords: Analytical Chemistry, Mass Spectrometry, Medical Device

Hendricker, Alan

doi:10.17632/rddfdc2p29.1

Qualification of a Gas Chromatography/Mass Spectrometry (GC/MS) Semi-quantitative Screening Method used for Analysis of Extractables and Leachables from Medical Devices, Medical Device Componentry and Other Associated Materials

Published: 15 December 2022| Version 1 | DOI: 10.17632/rddfdc2p29.1

Contributor:

Alan Hendricker

Description

This technical note summarizes the qualification of a GC-MS method qualification for use in general screening of extractables from medical devices.

Qualification of a Gas Chromatography/Mass Spectrometry (GC/MS) Semi-quantitative Screening Method used for Analysis of Extractables and Leachables from Medical Devices, Medical Device Componentry and Other Associated Materials

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