Linearity Testing in Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting linearity testing during the analytical method development process, ensuring the ability of the method to produce results that are directly proportional to the concentration of the analyte.

2) Scope

This SOP applies to all personnel involved in linearity 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 linearity 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 Standard Solutions:
   1. Prepare a series of standard solutions covering a range of concentrations of the analyte.
   2. Ensure accurate preparation and labeling of standard solutions.
3. Execution of Linearity Testing:
   1. Analyze the prepared standard solutions using the selected analytical method.
   2. Plot calibration curves and assess linearity by evaluating the correlation coefficient (R²) and residuals.
4. Data Analysis and Reporting:
   1. Analyze linearity testing data to determine the linearity range and correlation of the method.
   2. Document linearity testing results and conclusions in a linearity testing report.
5. Review and Approval:
   1. Review the linearity testing report for accuracy, completeness, and compliance with protocol requirements.
   2. Obtain necessary approvals from stakeholders before finalizing the linearity testing report.

5) Abbreviations, if any

The purpose of this SOP is to define the commonly used abbreviations related to linearity testing in analytical method development.

6) Documents, if any

List of documents to be maintained related to this SOP:

• Linearity Testing Report
• Standard Solution Preparation Records
• Data Analysis and Results Documentation
• Review and Approval Records
• Meeting Minutes

7) Reference, if any

Regulatory guidelines related to this SOP include:

• USP General Chapter Validation of Analytical Procedures
• ICH Q2(R1): Validation of Analytical Procedures

8) SOP Version

Version 1.0