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How can I conduct specificity and selectivity of validation?

The specificity and selectivity of a validation method refer to its ability to accurately determine the presence or absence of a specific analyte in a sample, without detecting other substances that may be present. To conduct specificity and selectivity testing, you can follow these steps:

Prepare standards of the analyte of interest, as well as standards of any substances that may interfere with the analysis.

Analyze the standards using the validation method.

Evaluate the results of the analysis to determine if the method is specific for the analyte of interest, meaning it does not produce false positive results for other substances. This can be done by comparing the response of the analyte to the responses of the interfering substances.

Evaluate the selectivity of the method, meaning its ability to distinguish the analyte of interest from similar compounds. This can be done by analyzing mixtures of the analyte with structurally similar compounds and comparing the response of the analyte to the responses of the similar compounds.

Finally, it is important to verify the accuracy of the method by analyzing real samples that are known to contain the analyte and comparing the results to a reference method or a known value.

It is important to note that specificity and selectivity are complex and interrelated concepts and may depend on the specific application, sample matrix, and measurement conditions. The results of the specificity and selectivity testing should be thoroughly evaluated and documented to ensure that the validation method is appropriate for its intended use.