Residue depletion study and withdrawal period for flunixin-N-methyl glucamine in bovine milk following intravenous administration |
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Authors: | Ngoh Maureen A Wislocki Peter G Thompson Kenneth Katz Terry Weingarten Allan TerHune Terry Hurshman Bret |
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Institution: | Drug Safety and Metabolism-Animal Health, Schering-Plough Research Institute, 144 Route 94 South, Lafayette, New Jersey 07848, USA. maureen.ngoh@spcorp.com |
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Abstract: | The objective of this study was to establish a withdrawal period for flunixin in milk by quantifying 5-hydroxyflunixin, the marker residue, in bovine milk as a function of time, following intravenous treatment of lactating dairy cows with flunixin-N-methyl glucamine (Banamine or Finadyne). Lactating dairy cows were dosed on three consecutive days at 2.2 mg of flunixin free acid/kg of body weight/day. Milk was collected twice daily and assayed using a liquid chromatography-mass spectrometry/mass spectrometry (LC-MS/MS) procedure. The method was validated at concentrations in the range 0.5-250 ppb. The concentrations for 5-hydroxyflunixin measured 12 h after the last administration of drug ranged from 1.56 to 40.6 ppb for all cows. Milk concentrations for 5-hydroxyflunixin were used to establish withdrawal periods of 36 h using guidelines established by the U.S. Food and Drug Administration/Center for Veterinary Medicine and 24 h using guidelines established by the European Medicinal Evaluation Agency/Committee on Veterinary Medicinal Products. |
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