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EU legislation regulates the use of veterinary drugs for food producing animals. The serious consequences of infractions mean that laboratory tests must produce highly reliable analytical results. Certified Reference Materials (CRM) are the tools used to provide European laboratories with a common level of analytical performance.

This report describes the preparation and certification of two batches of 500 lyophilised samples of bovine muscle tissue, respectively containing diethylstilboestrol (DES) or no exogenous compounds (blank). All analyses used for certification were performed by gas chromatography-mass spectrometry using isotope enriched internal standard. The results of the homogeneity and stability study indicate that the materials are homogeneous and stable and therefore suitable as CRM. Seventeen laboratories participated in the certification study. The materials were analysed using three different techniques, namely gas chromatography-mass spectrometry (12 laboratories), immunoassay (4 laboratories) and thin-layer chromatography (1 laboratory). Methods based on immunoassay measured only the trans-isomer of DES, and the limit of detection of the thin-layer chromatographic method was unacceptably high. Results obtained using these two methods were not used for certification. The results from 9 of the 12 laboratories that used gas chromatography-mass spectrometry for the analyses were by themselves considered acceptable for certification purposes. In view of the observed variability, it was decided to not fix certified values but to certify as �greater than� the mean � 2SD. In view of the zero-tolerance applicable world-wide for residues of DES the materials can be used as Reference Materials for the validation of methods for the detection and identification of DES in bovine muscle.

Additional information

Authors: VAN GINKEL L A, National Institute of Public Health, and the Environmental Laboratory for Residue Analysis, Bilthoven (NL);DIRSCHIRL C, European Commission, DG Research, Standards, Measurement and Testing Programme (SMT) Brussels (BE)
Bibliographic Reference: EUR 20480 EN (2003), 27pp. Free of charge
Availability: EUR-OP reference: KI-NA-20480-EN-C Available from: Documentation Service of DG Research Fax: +32 2 295 8220 E-mail:
ISBN: ISBN: 92-894-4577-7
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