Limit of Quantification (LOQ) Testing in Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting limit of quantification (LOQ) testing during the analytical method development process, determining the lowest concentration of an analyte that can be reliably quantified with acceptable precision and accuracy.

2) Scope

This SOP applies to all personnel involved in LOQ testing for analytical method development projects within the analytical development department.

3) Responsibilities

The purpose of this SOP is to define the roles and responsibilities of all personnel involved in LOQ testing.

4) Procedure

1. Selection of Analytical Method:
   1. Select appropriate analytical method based on method requirements and regulatory guidelines.
   2. Verify method suitability and performance characteristics.
2. Preparation of Sample Series:
   1. Prepare a series of samples with decreasing concentrations of the analyte, covering the expected LOQ range.
   2. Ensure accurate preparation and labeling of sample series.
3. Execution of LOQ Testing:
   1. Analyze each sample in the series using the selected analytical method.
   2. Determine the concentration at which the analyte can be reliably quantified with acceptable precision and accuracy (LOQ).
4. Data Analysis and Reporting:
   1. Analyze LOQ testing data to determine the LOQ value based on statistical methods.
   2. Document LOQ testing results and conclusions in an LOQ testing report.
5. Review and Approval:
   1. Review the LOQ testing