CLSI C43

Gas Chromatography/Mass Spectrometry Confirmation of Drugs, 2nd Edition

This document provides guidance on establishing uniform practices necessary to produce quality data for quantitation and identification of a drug or drug metabolite using the gas chromatography/mass spectrometry method. Specific quality assurance criteria for maintaining and documenting optimal instrument performance are also presented.

This document is available in electronic format only.

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Chairholder: Loralie J. Langman, PhD

Date of Publication: March 25, 2010

Order Code PDF: CLSI C43A2E
ISBN Number: 1-56238-720-0

Order Code Print: print not available

Edition: Second

Pages: 52

CLSI C43 Additional Details

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This document was formerly sold under the code T/DM10.

This archived document is no longer being reviewed through the CLSI Consensus Document Development Process. However, this document is technically valid as of September 2016. Because of its value to the laboratory community, it is being retained in CLSI’s library.

CLSI C43 Abstract

Clinical and Laboratory Standards Institute document C43-A2—Gas Chromatography/Mass Spectrometry Confirmation of Drugs; Approved Guideline—Second Edition is intended to aid the laboratorian in developing appropriate procedures for the use of gas chromatography/mass spectrometry in confirmation analyses. Its primary objective is to establish uniform practices necessary for producing quality data for quantitation and identification of a drug or drug metabolite. To support the scientific basis of the uniform practices, a brief overview of the techniques is provided. Specific quality assurance criteria for maintaining and documenting optimal instrument performance are presented.