Forensic investigation in the pharmaceutical industry: Identification procedure of visible particles in (drug) solutions and different containers by combining vibrational and X-ray spectroscopic techniques

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Abstract

Graphical abstract

Flow-chart of the foreign matter identification procedure.

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SEM/EDX: Scanning electron microscopy couple with energy-dispersive X-ray spectroscopy. FTIR: Fourier Transform Infrared spectroscopy.

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NMR: nuclear magnetic resonance.

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GC–MS: gas chromatography coupled with mass spectrometer.

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LC–MS: liquid chromatography couple with mass spectrometer.

Vibrational and X-ray spectroscopic techniques are based on the interaction between radiation and matter. This interaction produces various signals that can be detected and that contain information about the morphology, structure or composition of molecules analyzed. When combined together, these complementary techniques are very powerful and facilitate the identification of the samples investigated. Nevertheless, prior sample preparation plays an important role in this identification, since it should allow combining analytical methods without damaging the samples. Through 5 case studies involving visible particles found in various containers, this article shows how an accurate sample preparation procedure associated to a combination of Infrared, Raman and energy dispersive X-ray (EDX) spectroscopies applies for the troubleshooting of foreign matters in pharmaceutical drug products. The forensic investigation procedure proved to be successful for the precise identification of samples.

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