Developing Dissolution Methods for Analytical Method Development

1) Purpose

The purpose of this SOP is to outline the procedure for developing dissolution methods during the analytical method development process, ensuring accurate assessment of drug release from dosage forms.

2) Scope

This SOP applies to all personnel involved in developing dissolution 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 dissolution methods.

4) Procedure

1. Method Development Objectives:
   1. Define objectives for developing dissolution methods based on regulatory requirements and product specifications.
   2. Identify critical parameters such as dissolution medium, apparatus, and sampling intervals.
2. Selection of Dissolution Apparatus:
   1. Evaluate and select appropriate dissolution apparatus (e.g., USP apparatus I, II, IV) based on drug properties and dosage form characteristics.
   2. Consider method suitability, reproducibility, and discriminatory power.
3. Optimization of Method Parameters:
   1. Optimize dissolution method parameters including agitation speed, temperature, and sampling volume.
   2. Conduct method robustness testing to evaluate method performance under varied conditions.
4. Validation of Dissolution Methods:
   1. Validate dissolution methods according to regulatory guidelines and predefined acceptance criteria.
   2. Document validation results and conclusions regarding method suitability for dissolution testing.
5. Documentation and Reporting:
   1. Document all dissolution method development activities, including method objectives, apparatus selection, optimization, and validation.
   2. Prepare a dissolution method development report summarizing method development activities and outcomes.
6. Review and Approval:
   1. Review the dissolution method development report for accuracy, completeness, and compliance with protocol requirements.
   2. Obtain necessary approvals from stakeholders before finalizing the dissolution method development report.

5) Abbreviations, if any

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

6) Documents, if any

List of documents to be maintained related to this SOP:

• Dissolution 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:

• USP General Chapter Dissolution
• ICH Q2(R1): Validation of Analytical Procedures

8) SOP Version

Version 1.0