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Analytical Method Validation of Related substance or Residual solvents

The following parameters are considered during the analytical method validation of related substances or residual solvents:

1. Demonstration of precision

  • System precision / System suitability
  • Sample precision

2. Solution stability

3. Limit Of Detection (LOD)

4. Limit Of Quantification (LOQ)

  • Precision at LOQ level
  • Accuracy at LOQ level
  • Linearity at LOQ level

5. Accuracy

6. Linearity

7. Ruggedness

  • On the same column at spiked level
  • Variability from analyst to analyst
  • Variability from system to system
  • Variability from column to column
8. Robustness

  • Variability of column initial oven temperature
  • Variability of carrier gas flow rate

9. Different Batch analysis


Read also: Analytical Method Validation of Assay