Conducting Compatibility Studies for Formulation Development

1) Purpose

The purpose of this SOP is to outline the procedure for conducting compatibility studies during the formulation development process to ensure that the active pharmaceutical ingredient (API) and excipients are compatible and stable under various conditions.

2) Scope

This SOP applies to all formulation development projects within the organization, covering the entire compatibility study process from initial testing to final documentation.

3) Responsibilities

The responsibilities for this SOP include:
Project Manager: Overseeing the compatibility study process and ensuring it meets project objectives.
Team Members: Conducting the compatibility tests and analyzing the results.
Quality Assurance: Reviewing and approving the compatibility study documentation.

4) Procedure

4.1 Planning Compatibility Studies

1. Define the objectives and scope of the compatibility studies.
2. Select the API and excipients to be tested.
3. Develop a compatibility study plan, including testing methods and conditions.
4. Document the compatibility study plan.

4.2 Conducting Initial Screening

1. Prepare physical mixtures of the API and each excipient.
2. Conduct initial screening tests to identify any obvious incompatibilities (e.g., visual inspection, basic chemical tests).
3. Document the results of the initial screening tests.

4.3 Detailed Compatibility Testing

1. Conduct detailed compatibility tests under various conditions (e.g., temperature, humidity, light exposure).
2. Utilize appropriate analytical methods to assess the stability and compatibility of the