Analytical Test Method



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Analysis Repeatability Using Different Concentrations Analyte Level Concentration Level 1 Amount of Analyte Replicate 1 Replicate 2 Replicate 3 Acceptance Criteria Concentration Level 2 Replicate 1 Replicate 2 Replicate 3 Acceptance Criteria Concentration Level 3 Replicate 1 Replicate 2 Replicate 3 Acceptance Criteria Measured parameter Mean RSD P/F Repeatability using Multiple Determinations at the Test Concentration Determination Measured parameter Replicate 1 Replicate 2 Replicate 3 Replicate 4 Replicate 5 Replicate 6 Mean RSD Acceptance Criteria P/F 5.2.2.Intermediate Precision Depending on the nature of the analysis and results – visual inspection or quantitative data, either the appropriate figures or table should be included in this section.. Robustness: Standard Solution Stability Time 2 – 8 ºC Room Temperature of Analyte Difference P/F of Analyte Difference P/F Day 0 Day x Day Y Day Z Sample Solution Stability Time 2 – 8 ºC Room Temperature of Analyte Difference P/F of Analyte Difference P/F Day 0 Day x Day Y Day Z Method Parameter Test methods Parameter RSD (area) RRT Injection Volume (Nominal) Injection Volume 1 Injection Volume 2 Mobil Phase (Nominal) Mobil Phase 1 Mobil Phase 2 Column Temp..




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