Stability Testing of Analytical Solutions in Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting stability testing of analytical solutions during the analytical method development process, ensuring the stability of solutions over time.

2) Scope

This SOP applies to all personnel involved in stability testing of analytical solutions 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 stability testing of analytical solutions.

4) Procedure

1. Preparation of Analytical Solutions:
   1. Prepare analytical solutions according to method requirements and specifications.
   2. Ensure accurate preparation and labeling of analytical solutions.
2. Storage Conditions:
   1. Determine appropriate storage conditions based on the stability requirements of the analyte and method.
   2. Document storage conditions including temperature, humidity, and light exposure.
3. Execution of Stability Testing:
   1. Store analytical solutions under specified conditions for defined time periods.
   2. Periodically analyze samples to assess stability using the selected analytical method.
4. Data Analysis and Reporting:
   1. Analyze stability testing data to determine the stability characteristics of the analytical solutions.
   2. Document stability testing results and conclusions in a stability testing report.
5. Review and Approval:
   1. Review the stability testing report for accuracy, completeness, and compliance with protocol requirements.
   2. Obtain necessary approvals from stakeholders before finalizing the stability testing report.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• Stability Testing Report
• Analytical 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 Q1A(R2): Stability Testing of New Drug Substances and Products

8) SOP Version

Version 1.0