: Validation of Analytical Methods
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: Dr. Ludwig Huber

The process of analytical method’s validation should demonstrate that the method is fit for its purpose. The validation should follow a plan that includes the scope of the method, the method performance characteristics and acceptance limits. Parameters usually examined in the validation process are limits of detection and quantitation, accuracy, precision, selectivity/specificity, linearity, range and ruggedness. A validation report should be generated with all experimental conditions and the complete statistics. When ‘standard’ methods are used in the laboratory, their scope should be in line with the scope of the laboratories’ method requirements and the suitability of the entire analytical system in the specific laboratory’s environment should be verified for the method.

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