Production and certification of BOTS-1: Bovine muscle-certified reference material for incurred veterinary drug residues

Authors: MCRAE, GARNET - National Research Council - Canada; LEEK, DON - National Research Council - Canada; MEIJA, JURIS - National Research Council - Canada; SHURMER, BRYN - Canadian Food Inspection Agency; Lehotay, Steven; POLZER, JOACHIM - German Federal Office Of Consumer Protection And Food Safety (BVL); MELANSON, JEREMY - National Research Council - Canada; MESTER, ZOLTAN - National Research Council - Canada

Submitted to: Analytical and Bioanalytical Chemistry
Publication Type: Peer Reviewed Journal
Publication Acceptance Date: 6/5/2023
Publication Date: 6/16/2023
Citation: McRae, G., Leek, D., Meija, J., Shurmer, B., Lehotay, S.J., Polzer, J., Melanson, J.E., Mester, Z. 2023. Production and certification of BOTS-1: Bovine muscle-certified reference material for incurred veterinary drug residues. Analytical and Bioanalytical Chemistry. 416:759-771. https://doi.org/10.1007/s00216-023-04794-5.
DOI: https://doi.org/10.1007/s00216-023-04794-5

Interpretive Summary: Veterinary drug residues in meats need to be monitored worldwide to ensure compliance with domestic and international regulations, particularly for international food trade purposes. Analytical methods used to meet regulatory and other monitoring needs must be demonstrated to provide accurate quantitative results for a wide array of drugs, and the analysis of certified reference materials (CRMs) is the best way to demonstrate method performance by a laboratory. In this study, a new CRM known as BOTS-1 was generated by dosing live cattle with veterinary drugs, and the residue concentrations were verified in the meat by different methods and laboratories worldwide. The availability of this new CRM leads to better monitoring for veterinary drug residues in food, and greater confidence in the quality of results.

Technical Abstract: A freeze-dried bovine muscle certified reference material (CRM), known as BOTS-1, containing incurred residues of commonly used veterinary drugs was produced and certified for the mass fraction of eight veterinary drug residues. Value assignment was carried out using liquid chromatography tandem mass spectrometry methods in conjunction with isotope dilution and standard addition approaches involving stable isotope internal standards. Data from the National Research Council of Canada, Canadian Food Inspection Agency, United States Department of Agriculture, and the Federal Office of Consumer Protection and Food Safety in Germany were used for value assignment. Results for two drug residues were also obtained through an international inter-laboratory comparison organized under the auspices of the International Bureau of Weights and Measures. Quantitative NMR was used to characterize primary standards of all veterinary drugs certified. The certified mass fractions of the veterinary drug residues were 490 ± 100 µg/kg for chlorpromazine, 44 ± 4.4 µg/kg for ciprofloxacin, 3.3 ± 1.4 µg/kg for clenbuterol, 9.5 ± 0.8 µg/kg for dexamethasone, 57 ± 4.8 µg/kg for enrofloxacin , 3.0 ± 0.4 µg/kg for meloxicam, 12.4 ±1.2 µg/kg for ractopamine, and 2290 ± 120 µg/kg for sulfadiazine with expanded uncertainties quoted (95% confidence) which include the effects due to between-bottle inhomogeneity, instability during long-term storage and transportation, and characterization.