SOP Guide for Pharma

SOP for Preparation of Magnetic Nanoparticles for Biomedical Applications

SOP for Preparation of Magnetic Nanoparticles for Biomedical Applications

Standard Operating Procedure for Preparation of Magnetic Nanoparticles for Biomedical Applications

1) Purpose

This SOP outlines the procedure for synthesizing magnetic nanoparticles for biomedical applications, including targeted drug delivery, hyperthermia therapy, and MRI contrast enhancement.

2) Scope

This SOP applies to personnel involved in the preparation, characterization, and application of magnetic nanoparticles in pharmaceutical or biomedical research environments.

3) Responsibilities

  • Operators: Responsible for synthesizing and characterizing magnetic nanoparticles according to the outlined procedures.
  • QA: Ensures that the nanoparticles meet specifications for size, magnetization, and biocompatibility.

4) Procedure

4.1 Selection of Magnetic Materials

4.1.1 Iron Oxide Nanoparticles

  • 4.1.1.1 Use iron oxide (Fe3O4 or Fe2O3) as the core material for the magnetic nanoparticles, ensuring high magnetization and biocompatibility.

4.2 Synthesis of Magnetic Nanoparticles

4.2.1 Co-precipitation Method

  • 4.2.1.1 Synthesize magnetic nanoparticles using the co-precipitation method by mixing iron salts (Fe2+ and Fe3+) in an aqueous solution and precipitating them with a base under controlled conditions.

4.3 Surface Functionalization

4.3.1 Coating with Biocompatible Polymers

  • 4.3.1.1 Coat the magnetic nanoparticles with biocompatible polymers such as PEG or dextran to improve stability, biocompatibility, and reduce aggregation.

4.4 Characterization

4.4.1 Particle Size and Magnetization

  • 4.4.1.1 Measure the particle size using dynamic light scattering (DLS) and evaluate the magnetic properties using a vibrating sample magnetometer (VSM).

4.4.2 Biocompatibility Testing

  • 4.4.2.1 Perform in
vitro cytotoxicity assays to ensure the nanoparticles are safe for biomedical applications.

4.5 Storage

4.5.1 Storage Conditions

  • 4.5.1.1 Store the magnetic nanoparticles in sterile containers at 4°C, ensuring the suspension remains stable and does not aggregate over time.

5) Abbreviations, if any

  • DLS: Dynamic Light Scattering
  • PEG: Polyethylene Glycol
  • VSM: Vibrating Sample Magnetometer

6) Documents, if any

  • Magnetic Nanoparticle Synthesis Logbook

7) References, if any

  • Protocols for magnetic nanoparticle synthesis and biomedical applications

8) SOP Version

Version 1.0

Annexure

Magnetic Nanoparticle Synthesis Logbook Template

Date Batch Number Core Material Particle Size Magnetic Properties Operator Initials QA Initials
DD/MM/YYYY Batch Number Core Material Size in nm Magnetization (emu/g) Operator Name QA Name
           
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