SOP for Optimization of Solvent Removal Techniques in Nanoparticle Formulations

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

acceptable limits.

4.3 Stability Testing

4.3.1 Stability Studies

4.3.1.1 Perform stability studies on the nanoparticles after solvent removal to ensure that the formulation remains stable and the particle size does not change over time.

4.4 Storage

4.4.1 Storage Conditions

4.4.1.1 Store the nanoparticles in sterile containers at 4°C to maintain stability after solvent removal.

5) Abbreviations, if any

DLS: Dynamic Light Scattering
GC: Gas Chromatography

6) Documents, if any

Solvent Removal Optimization Logbook

7) References, if any

Protocols for optimizing solvent removal in nanoparticle formulations

8) SOP Version

Version 1.0

Annexure

Solvent Removal Optimization Logbook Template


  
    Date
    Batch Number
    Solvent Used
    Particle Size
    Residual Solvent Content
    Operator Initials
    QA Initials
  
  
    DD/MM/YYYY
    Batch Number
    Solvent Name
    Size in nm
    Content in ppm
    Operator Name
    QA Name

Date	Batch Number	Solvent Used	Particle Size	Residual Solvent Content	Operator Initials	QA Initials
DD/MM/YYYY	Batch Number	Solvent Name	Size in nm	Content in ppm	Operator Name	QA Name