appropriate.] B.5.2-1. Overview of the Analytical Methods for the Determination of [Active Ingredient] Residues. Data Requirement Matrix Analytes Method Type Limit of Quantitation (ppm) Reference Enforcement Method- Plant Commodities [i.e., LC-MS/MS] 0.xx OR 0.xx all matrices except: 0.xx ([matrix], all analytes) Study No. XX MRID xxxxxxx PMRA# xxxxxx Data-Gathering Method- Plant Commodities [i.e., LC-MS/MS] 0.xx OR 0.xx all matrices except: 0.xx ([matrix], all analytes) Study No. XX MRID xxxxxxx PMRA# xxxxxx ILV of Enforcement Method- Plant Commodities Study No. XX MRID xxxxxxx PMRA# xxxxxx Radiovalidation of Methods - Plant Commodities N/A N/A Study No. XX MRID xxxxxxx PMRA# xxxxxx Enforcement Method- Livestock Commodities [i.e., LC-MS/MS] 0.xx OR 0.xx all matrices except: 0.xx ([matrix], all analytes) Study No. XX MRID xxxxxxx PMRA# xxxxxx Data-Gathering Method- Livestock Commodities [i.e., LC-MS/MS] 0.xx OR 0.xx all matrices except: 0.xx ([matrix], all analytes) Study No. XX MRID xxxxxxx PMRA# xxxxxx ILV of Enforcement Method- Livestock Commodities No. XX MRID xxxxxxx PMRA# xxxxxx Radiovalidation of Methods - Livestock Commodities N/A N/A Study No. XX MRID xxxxxxx PMRA# xxxxxx Multiresidue Method Testing FDA-Pesticide Analytical Methods testing program Study No. XX MRID xxxxxxx PMRA# xxxxxx Table B.5.2-2. Chemical Structures of Analytes Addressed by Methods for the Analysis of [Active Ingredient]. Method ID Chemical Name Chemical Structure Residue
m/z xxx→yyy (quantitation) yy zz Analyte 1 m/z xxx→yyy (quantitation) Matrix 2 xx yy zz Analyte 1 m/z xxx→yyy (quantitation) Matrix 3 xx yy zz Analyte 2 m/z xxx→yyy (quantitation) Matrix 1 xx yy zz Analyte 2 m/z xxx→yyy (quantitation) Matrix 2 xx yy zz Analyte 2 m/z xxx→yyy (quantitation) Matrix 3 xx yy zz Analyte 1 m/z xxx→yyy (confirmation) Matrix 1 xx yy zz Analyte 1 m/z xxx→yyy (confirmation) Matrix 2 xx yy zz Analyte 1 m/z xxx→yyy (confirmation) Matrix 3 xx yy zz Analyte 2 m/z xxx→yyy (confirmation) Matrix 1 xx yy zz Analyte 2 m/z xxx→yyy (confirmation) Matrix 2 xx yy zz Analyte 2 m/z xxx→yyy (confirmation) Matrix 3 xx yy zz Analytical Method [Method ID] was [successfully/not successfully] validated by an independent a laboratory and/or personnel unfamiliar with the method. Samples of [matrices] were spiked with [analytes] at levels ranging from [xx] to [yy] ppm. Recovery of analytes from spiked samples ranged from [xx] to [yy]% with a maximum relative standard deviation of [xx]% B.5.2.1.1-4). Contact with the sponsor [was/was not] required and acceptable recoveries were obtained after [x] trials. The validating laboratory recommends the following revisions to the method: Revision 1 Revision 2 Etc. Table B.5.2.1.1-4. Accuracy and Precision Data for the Independent Laboratory Validation of [Method ID] for Plant Matrices. Analyte Matrix Fortification Level (ppm) Independent Laboratory Validation Recovery (%) RSD (%) Individual Mean Range Analyte 1 Matrix 1 xx
m/z xxx→yyy (quantitation) yy zz Analyte 1 m/z xxx→yyy (quantitation) Matrix 2 xx yy zz Analyte 1 m/z xxx→yyy (quantitation) Matrix 3 xx yy zz Analyte 2 m/z xxx→yyy (quantitation) Matrix 1 xx yy zz Analyte 2 m/z xxx→yyy (quantitation) Matrix 2 xx yy zz Analyte 2 m/z xxx→yyy (quantitation) Matrix 3 xx yy zz Analyte 1 m/z xxx→yyy (confirmation) Matrix 1 xx yy zz Analyte 1 m/z xxx→yyy (confirmation) Matrix 2 xx yy zz Analyte 1 m/z xxx→yyy (confirmation) Matrix 3 xx yy zz Analyte 2 m/z xxx→yyy (confirmation) Matrix 1 xx yy zz Analyte 2 m/z xxx→yyy (confirmation) Matrix 2 xx yy zz Analyte 2 m/z xxx→yyy (confirmation) Matrix 3 xx yy zz V. Limit of Quantitation Table B.5.2.1.1-5. Summary of Detection and Quantitation Limits for [Method ID]. Analyte LOD (ppm)1 LOQ (ppm)2 1 LOD = of detection, determined by [explain]. 2 LOQ = of quantitation, defined as the lowest fortification level where acceptable precision and accuracy data were obtained. VI. Conclusions Pending revision recommended by the independent validation laboratory, the analytical
m/z xxx→yyy (quantitation) yy zz Analyte 1 m/z xxx→yyy (confirmation) Matrix 1 xx yy zz Analyte 1 m/z xxx→yyy (confirmation) Matrix 2 xx yy zz Analyte 1 m/z xxx→yyy (confirmation) Matrix 3 xx yy zz Analyte 2 m/z xxx→yyy (confirmation) Matrix 1 xx yy zz Analyte 2 m/z xxx→yyy (confirmation) Matrix 2 xx yy zz Analyte 2 m/z xxx→yyy (confirmation) Matrix 3 xx yy zz Analytical Method [Method ID] was [successfully/not successfully] validated by an independent a laboratory and/or personnel unfamiliar with the method. Samples of [matrices] were spiked with [analytes] at levels ranging from [xx] to [yy] ppm. Recovery of analytes from spiked samples ranged from [xx] to [yy]% with a maximum relative standard deviation of [xx]% (Table B.5.2.2.1-4). Contact with the sponsor [was/was not] required and acceptable recoveries were obtained after [x] trials. The validating laboratory recommends the following revisions to the method: Revision 1 Revision 2 Etc. B.5.2.2.1-4. Accuracy and Precision Data for the Independent Laboratory Validation of [Method ID] for Livestock Matrices. Analyte Matrix Fortification (ppm) Independent Laboratory Validation Recovery (%) RSD (%) Individual Mean Analyte 1 m/z xxx→yyy (quantitation) Matrix 1 xx yy zz Analyte 1 m/z xxx→yyy (quantitation) Matrix 2 xx yy zz Analyte 1 m/z xxx→yyy (quantitation) Matrix 3 xx yy zz Analyte 2 m/z xxx→yyy (quantitation) Matrix 1 xx yy zz Analyte 2 m/z xxx→yyy (quantitation) Matrix 2 xx yy zz Analyte 2 Matrix 3 xx