European Pharmacopoeia Revises Raman Spectroscopy Chapter

January 20, 2016
Pharmaceutical Technology Editors

The European Pharmacopoeia rewrites in its general chapter on Raman spectroscopy.

In response to the increased attention on Raman spectroscopy and the development of new Raman technologies, the European Pharmacopoeia Commission has revised its General Chapter on Raman Spectroscopy (2.2.48), which will be published in Supplement 8.7.

The revised chapter, which goes into effect on April 1, 2016, updates the reference standards or reagents used to verify wavenumber scale. Indene and naphthalene have been replaced by polystyrene and paracetamol, but cyclohexane has been kept. According to a European Directorate for the Quality of Medicines & Healthcare (EDQM) press release, “Polystyrene standards are widely available and already used in practice. Paracetamol is a very relevant substance for the pharmaceutical industry: stable and easy to work with. EDQM now provides a defined Chemical Reference Substance ‘paracetamol for equipment qualification CRS’. With these three reference standards and reagents, liquid, powder and polymer materials are covered. This enables the user to choose a standard typical of the physical state of the material to be examined.”

In another revision, the commission is elaborating on the Chemical Imaging chapter. The chapter will be open for public consultation from April–June 2016.

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