European Pharmacopoeia Publishes Chemical Imaging Chapter

The European Directorate for the Quality of Medicines & Healthcare (EDQM)

on January 5, 2017 that the European Pharmacopoeia Commission had adopted chapter 5.24 Chemical Imaging in November 2016. The non-mandatory general chapter was created to further the use of chemical imaging in pharmaceutical formulation, analytical development, quality control, and manufacturing.  The final text will be published in Supplement 9.3 in July 2017.

The new chapter addresses mid-infrared, near-infrared, and Raman spectroscopy and offers recommendations for the assessment of the performance of chemical imaging systems, including spectral and spatial components. The following elements are discussed in the chapter:

• An introduction to chemical imaging including explanations of datacubes and higher dimensional chemical imaging

• Applications

• A description of selected chemical imaging systems

• Explanations of elements of a chemical imaging process

• Recommendations for control of instrument performance

• Image processing and image analysis.

EDQM states that chemical imaging, which combines sensing technology with data analysis to characterize a sample area in chemical and physical terms, can be applied “to assess the identity, concentration and distribution of pharmaceutical ingredients in bulk or solid dosage forms, biological samples or packaging materials.”  Users of chemical imaging can create “visual images of component distribution measured.”

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