Specificity Testing in Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting specificity testing during the analytical method development process, ensuring the ability of the method to distinguish the analyte from potential matrix components or impurities.

2) Scope

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

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• Specificity 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