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A picture is worth a thousand words

New Ph. Eur. chapter “Chemical Imaging” planned

Chemical imaging is becoming increasingly important in the pharmaceutical industry with applications in identification of counterfeit medicinal products, examination of packaging materials and production equipment and identification of foreign particles or contaminants, to name but a few. The European Pharmacopeia has recognized this trend. With the aim to further the use of chemical imaging in the development, production and quality control of pharmaceutical products, the draft chapter 5.24. “Chemical Imaging” was published in Pharmeuropa (i), outlining principle, applications, technical aspects, procedures and control of instrument performance.

Solvias stays ahead and recently expanded its IR microscopy and imaging capabilities. We can now offer our customers highly spatially resolved spectral information of their samples in demonstrative pictures.

What is Chemical Imaging and how can it help you?

Definition

Chemical Imaging describes the spatially resolved recording of chemical and physical properties of a sample. The information is primarily obtained from the surface. For each surface location (pixel) in an x-y-grid spectral information is collected and transformed into a two-dimensional image of the surface area. This way, chemical components can be identified, quantified and their distribution on the surface of a sample made visible. Typical methods used for chemical imaging are MIR, NIR, and Raman spectroscopy.

Applications

Chemical imaging can be used “to assess identity, quality and quantity of active ingredients, intermediates, and excipients in bulk or solid dosage forms, biological samples, packaging and devices.” (i). It can be highly useful in the characterization of formulations, e.g. tablets, with respect to distribution of active pharmaceutical ingredient and excipients. Possible applications in packaging are the identification and determination of thickness of different layers of polymer films and the examination of materials for physical defects. Chemical imaging can help identify foreign particles and contaminations, e.g. on manufacturing equipment or medical devices. It can facilitate root cause investigations and help understand processes.

Chemical Imaging at Solvias

MIR spectroscopy

With our recent investments in our MIR microscopy and imaging capabilities we can now support our customers even better by offering highly spatially resolved spectral information detailing critical chemical parameters of their samples. Our new Perkin Elmer Spotlight 400 FT-IR microscope equipped with a Germanium ATR imaging crystal allows the fast collection of data within a sample diameter of 500 µm with pixel sizes ranging from 6.25 µm to 50 µm. This information can be used in the identification of counterfeit medicines, to support pharmaceutical research and development, to optimize products and processes or to learn about the competition.

Supporting techniques

As is almost usual with Solvias - with its unique range of high end innovative methods - that we have a choice of supporting techniques available, that may provide supplementary data to MIR imaging or can be used as an alternative. Raman microscopy can deliver additional spatially resolved spectral information. Additional morphological information can be gained by light microscopy or SEM (scanning electron microscope). The latter in combination with EDX (energy dispersive x-ray spectrometry) allows to obtain elemental distribution images.

Key areas where Solvias can support you:

  • Product defect analysis
  • Identification of contaminations and foreign particles
  • Impurity identification
  • Identification/ evaluation of counterfeit medicines
  • Pharmaceutical tablet and formulation analysis
  • Other component distribution studies
  • Biomaterial studies such as tissue, bone, teeth, leaves, etc.


Please contact your Solvias business developer for details.


i Pharmeuropa 28.2, chapter 5.24. Chemical Imaging, reference PA/PH/Exp. VSADM/T 2 ANP

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