Stability Testing of Analytical Standards in Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting stability testing of analytical standards during the analytical method development process, ensuring the reliability and accuracy of standards used for method validation and routine testing.

2) Scope

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

4) Procedure

1. Selection of Analytical Standards:
   1. Select appropriate analytical standards based on method requirements and regulatory guidelines.
   2. Verify the authenticity, purity, and stability of selected standards.
2. Preparation of Standard Solutions:
   1. Prepare standard solutions of selected analytical standards according to defined concentration ranges.
   2. Ensure accurate preparation and labeling of standard solutions.
3. Stability Testing Protocol:
   1. Define stability testing protocol including storage conditions (temperature, humidity), duration, and sampling intervals.
   2. Monitor stability samples regularly and assess degradation over time.
4. Data Analysis and Reporting:
   1. Analyze stability data to determine the shelf life and storage conditions of analytical standards.
   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 standards for analytical method development.

6) Documents, if any

List of documents to be maintained related to this SOP:

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

8) SOP Version

Version 1.0