Developing Stability Indicating Methods for Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for developing stability indicating methods during the analytical method development process, ensuring methods capable of detecting and quantifying degradation products in stability studies.

2) Scope

This SOP applies to all personnel involved in developing stability indicating methods 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 developing stability indicating methods.

4) Procedure

1. Method Development Objectives:
   1. Define objectives for developing stability indicating methods based on stability study requirements.
   2. Identify degradation pathways and critical degradation products to be monitored.
2. Method Selection:
   1. Select appropriate analytical techniques and conditions to ensure separation and quantification of degradation products.
   2. Evaluate method specificity and selectivity through forced degradation studies.
3. Optimization of Method Parameters:
   1. Optimize method parameters such as mobile phase composition, column temperature, and detection wavelength.
   2. Conduct robustness testing to assess method performance under variable conditions.
4. Validation of Stability Indicating Methods:
   1. Validate stability indicating methods according to regulatory guidelines and predefined acceptance criteria.
   2. Document validation results and conclusions regarding method suitability for stability studies.
5. Documentation and Reporting:
   1. Document all stability indicating method development activities, including method objectives, selection, optimization, and validation.
   2. Prepare a stability indicating method development report summarizing method development activities and outcomes.
6. Review and Approval:
   1. Review the stability indicating method development report for accuracy, completeness, and compliance with protocol requirements.
   2. Obtain necessary approvals from stakeholders before finalizing the stability indicating method development report.

5) Abbreviations, if any

The purpose of this SOP is to define the commonly used abbreviations related to stability indicating method development for analytical method development.

6) Documents, if any

List of documents to be maintained related to this SOP:

• Stability Indicating Method Development Report
• Validation Results Documentation
• Robustness Testing Records
• Review and Approval Records
• Meeting Minutes

7) Reference, if any

Regulatory guidelines related to this SOP include:

• ICH Q1A(R2): Stability Testing of New Drug Substances and Products
• ICH Q2(R1): Validation of Analytical Procedures

8) SOP Version

Version 1.0