Standard Operating Procedure for Solvent Selection and Preparation for Lyophilized Formulations

1) Purpose

This SOP defines the procedure for selecting and preparing solvents used in lyophilized formulations, ensuring the solvents meet the required specifications for product quality and stability.

2) Scope

This SOP applies to the selection and preparation of solvents by formulation scientists, operators, and QA teams involved in lyophilized product development.

3) Responsibilities

• Operators: Responsible for preparing solvents as per the procedure.
• Formulation Scientists: Responsible for selecting the appropriate solvent for each formulation.
• QA: Responsible for verifying solvent quality and process documentation.

4) Procedure

4.1 Solvent Selection

4.1.1 Criteria for Solvent Selection

• 4.1.1.1 The solvent should be non-reactive with active pharmaceutical ingredients (API).
• 4.1.1.2 The solvent should facilitate efficient lyophilization.
• 4.1.1.3 Ensure the solvent is compatible with the lyophilization equipment.
• 4.1.1.4 The solvent must meet pharmacopoeial standards (e.g., USP, EP).

4.2 Solvent Preparation

4.2.1 Equipment Preparation

• 4.2.1.1 Clean and calibrate measuring equipment such as volumetric flasks and graduated cylinders.
• 4.2.1.2 Ensure that containers are properly labeled and sanitized.

4.2.2 Solvent Measurement

• 4.2.2.1 Measure the required quantity of solvent as per the formulation guidelines.
• 4.2.2.2 Verify the measurements with a second operator for accuracy.

4.2.3 Mixing Procedure

• 4.2.3.1 If necessary, mix the solvent with other excipients or solvents in the appropriate ratio.
• 4.2.3.2 Use mechanical