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Bayer CropScience AG Page 30 of 82 BCS-RD-D-ROCS Method-No. 00857 D-40789 Monheim Report No. MR-099/04 4.4.1 Calculation of Individual Residues Evaluation is performed according to the external bracketing procedure against standards in solvent using a stable-labelled internal standards. 1. Calculate the average peak area ratios (unlabelled compound/labelled compound) of the bracketing standards for each compound. These values will be used as FSt. 2. Determine the average peak area ratios for the analysed samples for each compound. These values will be used as FA. 3. Calculate the amount of residue R expressed in mg/kg as follows: R i F = A * V End F St * * STA * V G * V A E * D where: Ri : Determined amount of residue in mg/kg FA : Average peak area ratio of the analytical solution VEnd : Final volume of the sample solution in mL (may be adjusted according to the expected residue level) STA : Standard concentration in the external standard in µg/mL VE : Extract volume in mL DF : Dilution factor FSt : Average peak area ratio for the bracketing standards G : Sample weight of analytical sample in g VA : Aliquot (of extract) in mL F 4.4.2 Calculation of Recovery Rates 1. Calculate the average of the residues in the recovery sample according to 4.4.1. 2. Calculate the percent recovery rate as follows: Rec F = A * V End * F St STA * VE * DF * 100 * V * A A where: Rec : Recovered amount found in fortified sample in % FA : Average peak area ratio of the analytical solution VEnd : Final volume of the sample solution in mL STA : Standard concentration in the external standard in µg/mL VE : Extract volume in mL DF : Dilution factor FSt : Average peak area for the bracketing standards VA : Aliquot (of extract) in mL A : Fortified amount in µg
Bayer CropScience AG Page 31 of 82 BCS-RD-D-ROCS Method-No. 00857 D-40789 Monheim Report No. MR-099/04 4.4.3 Calculation of Total Residue of BYI08330 For residue samples, the total residue of BYI08330 is calculated by summing up the individual residues obtained for the parent BYI8330 and the metabolites BYI08330-enol, BYI08330-ketohydroxy, BYI08330-mono-hydroxy and BYI08330-enol-glucoside, each of the metabolite residues expressed as BYI8330 parent equivalents. The total residue is calculated as BYI08330 parent, so that correction factors (CF) calculated from the different molecular weights are used. 1. Calculate the residues of the metabolites as BYI08330 parent equivalents as follows: R Metabolite as BYI08330 = R Metabolite ∗CF RMetabolite as BYI08330 : Residues of metabolites, calculated as BYI08330 parent equivalents in mg/kg RMetabolite : Residues of metabolites, determined according to 4.4.1 in mg/kg : Conversion factor CF M : Molecular weight in g/mol MParent Compound M Metabolite 2. Sum up the individual residues of the metabolites (expressed as BYI8330 parent equivalents) and the measured residue of BYI08330 (each in mg/kg) to the total BYI8330 residue. If all individual residues are below the respective LOQs, the total residue of BYI08330 is quoted as < 0.055 mg/kg (0.055 mg/kg is the sum of the LOQs of all analytes expressed as BYI8330 equivalents). If one or more individual residues are at or above the respective LOQ, the other residues, which are between the respective LOQs and LODs, will be set to their respective LOQs. Individual residues below the respective LOD will be set to 0 mg/kg for the calculation of the total residue of BYI08330. = C F
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