Selectivity Testing in Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting selectivity testing during the analytical method development process, ensuring the ability of the method to differentiate the analyte from potential interferences.

2) Scope

This SOP applies to all personnel involved in selectivity 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 selectivity 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. Identification of Potential Interferences:
   1. Identify potential interferences (e.g., impurities, degradation products) that may co-elute with the analyte.
   2. Evaluate the selectivity of the method to ensure accurate quantification and identification of the analyte.
3. Execution of Selectivity Testing:
   1. Perform selectivity testing using a matrix that contains potential interferences.
   2. Assess method performance by analyzing the ability to separate and quantify the analyte in the presence of interferences.
4. Data Analysis and Reporting:
   1. Analyze selectivity testing data to evaluate method selectivity and identify any co-eluting compounds.
   2. Document selectivity testing results and conclusions in a selectivity testing report.
5. Review and Approval:
   1. Review the selectivity testing report for accuracy, completeness, and compliance with protocol requirements.
   2. Obtain necessary approvals from stakeholders before finalizing the selectivity testing report.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• Selectivity Testing Report
• Method Validation 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