Ph. Eur. Draft General Chapter 5.24. Chemical Imaging

Recommendation

10/11 October 2023

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As reported in our GMP News on the revised General Chapter on Raman Spectroscopy the European Pharmacopoeia is elaborating a chapter on Chemical Imaging. The draft chapter "5.24. Chemical Imaging" has now been published in Pharmeuropa 28.2 for public consultation till June 30, 2016.

The purpose of this general chapter is to encourage the use of chemical imaging for analyzing pharmaceutical products in formulation and analytical development, regulated pharmaceutical quality assurance and control, and in manufacturing environments.

The Scope of the chapter emphasizes that Chemical Imaging (CI) combines sensing technologies with data analysis techniques to characterise a sample in chemical and physical terms, using information primarily obtained from the surface. The technique is particularly suited to the analysis of solid, semi-solid and liquid samples with regard to material properties, including component identity (active pharmaceutical ingredients and excipients), domain size and distribution, polymorphism, and particle morphology.

Thus imaging can be applied to assess identity, quality and quantity of active ingredients, intermediates, and excipients in bulk or solid dosage forms, biological samples, packaging and devices. Imaging is used to explore sample homogeneity, detect physical sample defects (e.g. cracks in cores or coatings), and identify foreign particles or contaminants. It also facilitates process understanding and root cause determination. Lastly, it is a tool to evaluate falsified or counterfeit medicinal products.

The general chapter’s primary focus is on chemical imaging systems (CIS) based on surface analysis performed with vibrational spectroscopy, i.e. mid-infrared spectroscopy (2.2.24), near-infrared spectroscopy (2.2.40) and Raman spectroscopy (2.2.48). Raman spectroscopy is increasingly used for Process Analytical Technology (PAT) or for chemical imaging applications. However, it also applies to other techniques that supply images.

The general chapter offers specific recommendations to assess the performance of chemical imaging systems for the qualitative and quantitative exploitation of images. Performance requirements provided in Ph. Eur. general methods need not be applied as long as CI systems are primarily intended for investigative purposes.

Following your registration on the Pharmeuropa website you can get to the complete draft chapter 5.24. "Chemical Imaging".