WHO Supplementary Training Modules: Validation, Water, Air Handling Systems - Validation (Part 4): Analytical Method Validation: Validation

WHO Supplementary Training Modules: Validation, Water, Air Handling Systems - Validation (Part 4): Analytical Method Validation
(2006; 27 pages)

Table of Contents

Validation

Factors that can have an effect on robustness when performing chromatographic analysis include:

- stability of test and standard samples and solutions

- reagents (e.g. different suppliers)

- different columns (e.g. different lots and/or suppliers)

- extraction time

- variations of pH of a mobile phase

- variations in mobile phase composition

- temperature

- flow rate

6.1.3.1 Factors that can have an effect on robustness when performing chromatographic analysis include:

- stability of test and standard samples and solutions;

- reagents (e.g. different suppliers);

- different columns (e.g. different lots and/or suppliers);

- extraction time;

- variations of pH of a mobile phase;

- variations in mobile phase composition;

- temperature; and

- flow rate.