Standard Operating Procedure for Optimization of Solvent Removal Techniques in Nanoparticle Formulations

1) Purpose

This SOP outlines the procedure for optimizing solvent removal techniques in nanoparticle formulations, ensuring efficient evaporation of solvents while maintaining nanoparticle stability and size.

2) Scope

This SOP applies to personnel responsible for optimizing solvent removal in nanoparticle formulations prepared by solvent evaporation, emulsification, or nanoprecipitation methods.

3) Responsibilities

• Operators: Responsible for performing solvent removal as per this SOP, ensuring optimal nanoparticle properties.
• QA: Ensures the final formulation meets specifications for solvent content, particle size, and stability.

4) Procedure

4.1 Solvent Evaporation Techniques

4.1.1 Rotary Evaporation

• 4.1.1.1 Use a rotary evaporator to remove solvents at reduced pressure, optimizing the rotation speed, temperature, and vacuum level to ensure efficient solvent removal without destabilizing the nanoparticles.

4.1.2 Vacuum Drying

• 4.1.2.1 After the initial solvent removal, use vacuum drying to further reduce the solvent content in the formulation, ensuring no residual solvents remain.

4.2 Particle Size and Solvent Residue Testing

4.2.1 Particle Size Measurement

• 4.2.1.1 Measure the particle size using dynamic light scattering (DLS) after solvent removal to ensure no aggregation or size increase due to inadequate solvent evaporation.

4.2.2 Residual Solvent Testing

• 4.2.2.1 Conduct residual solvent analysis using gas chromatography (GC) to ensure solvent content is below