Analysis of Particle Identification by Fourier Transform Infrared (FTIR) Microscopy (CAT#: STEM-B-0366-CJ)

Introduction

Determining the origin and identity of particulate matter in (bio)pharmaceutical drug products is crucial for troubleshooting and root-cause analysis and, thus, often very time-critical. The identification approach includes the visual inspection of the sample inside the primary container, a high-resolution photo documentation of the particles and a subsequent identification of the isolated particles by a range of specialized analytical techniques, including FTIR microscopy, SEM-EDX and Raman.

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Principle Applications Procedure Materials Notes Related Products

Principle

FTIR is concerned with the vibration of molecules. Each functional group has its own discrete vibrational energy which can be used to identify a molecule through the combination of all of the functional groups. This makes FTIR microscopy ideal for sample ID, multilayer film characterization, and particle analysis.

Applications

Biopharmaceutica

Procedure

1. Sample preparation
2. (sub)visible particles present in a sample are first isolated on a filter, preferably a metal-coated membrane or a gold filter.
3. bright field images are taken from the particles and IR spectra are obtained for each individual particle.
4. Data analysis.

Materials

• Sample: Particle-based APIs (e.g., VLPs, liposomes, polymeric nanoparticles), Virus Particle, Protein Formulations
• Equipment: Fourier Transform Infrared (FTIR) Microscopy

Notes

• Advantage: Can provide chemical identity, secondary structure of proteins in particles.
• Disadvantage: Costly equipment, low throughput, not quantitative (particle counts), water can interfere with signal.
• Sample Size Range: 10 µm – cm.

Other recommended products

Analysis of Particle Identification by Raman Microscopy (CAT#: STEM-B-0367-CJ)
Analysis of Particle Identification by SEM-EDS (CAT#: STEM-B-0368-CJ)