Establishing the fitness for purpose of mass spectrometric methods

Author:

Bethem Robert1,Boison Joe2,Gale Jane3,Heller David4,Lehotay Steven5,Loo Joseph6,Musser Steven7,Price Phil8,Stein Stephen9

Affiliation:

1. Alta Analytical Laboratory, El Dorado Hills, California, USA

2. Canadian Food Inspection Agency, Saskatoon, Saskatchewan, Canada

3. Bristol-Myers Squibb, New Brunswick, New Jersey, USA

4. FDA Center for Veterinary Medicine, Laurel, Maryland, USA

5. USDA/ARS Eastern Regional Research Center, Wyndmoor, Pennsylvania, USA

6. Pfizer Global Research and Development, Ann Arbor, Michigan, USA

7. FDA Center for Food Safety and Applied Nutrition, Washington, D.C., USA

8. Dow Chemical, South Charleston, West Virginia, USA

9. National Institute of Standards and Technology, Gaithersburg, Maryland, USA

Publisher

American Chemical Society (ACS)

Subject

Spectroscopy,Structural Biology

Reference18 articles.

1. Limits to Confirmation, Quantitation, and Detection, ASMS Fall Workshop; Alexandria, VA, Nov. 1996

2. Report

3. Mass spectrometry in trace analysis

4. Documents used in the 2001 survey of draft guidance documents. (a) COMMISSION OF THE EUROPEAN COMMUNITIES, draft SANCO/1805/2000 Rev. 1, Commission decision laying down performance criteria for the analytical methods to be used for certain substances and residues thereof in live animals and animal products according to Council Directive 96/23/EC. (b) Document C43-P, Vol. 20, No. 9, Gas Chromatography/Mass Spectrometry (GC/MS) Confirmation of Drugs; Proposed Guideline, Draft prepared for comment period ending November 2000, by National Committee for Clinical Laboratory Standards, Wayne, PA. (c) U.S. Department of Agriculture, Agricultural Marketing Service, Pesticide Data Program (www.ams.usda.gov/science/pdp/SOPs.htm) SOP no. PDP-QC-06, Minimum Requirements for QC/Quadrupole Mass Spectrometer Confirmation in EI mode, Effective 04/01/00. SOP no. PDP-QC-09, Minimum Requirements for the Operation of a Mass Spectrometer with MS/MS Capabilities, Effective 04/01/00. SOP no. PDP-QC-10, Determination of LOD and LOQ for Chromatographic Methods, Effective 02/01/96. SOP no. QC-11, Ion Trap Confirmation Guidelines, Effective 3/2/94. (d) Reports no. KOA 98.222 and KOA-00.100, Identification criteria for the GC-MS analysis of environmental contaminants in various matrices, prepared by KIWA N.V. for Netherlands laboratories that monitor for environmental contaminants in water and soil. Also described by Geerdink [10]. (e) FDA Center for Veterinary Medicine, Draft Guidance Document no.118, Mass Spectrometry for Confirmation of the Identity of Animal Drug Residues, version of June 2001.

5. Quality concepts and practices applied to sampling—an exploratory study

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