European Pharmacopoeia adopts revised Raman spectroscopy chapter

The revised Raman Spectroscopy chapter (2.2.48) will be released in October, with updates focusing on enhancing the reliability of the results.

Handheld Raman spectrometer

The European Pharmacopoeia (Ph. Eur.) Commission has announced that it adopted the revised chapter 2.2.48 on Raman Spectroscopy at its 169th session in March 2021.

In the statement announcing the development, Ph. Eur. Explained that Raman spectrometers are increasingly being deployed in the pharmaceutical environment because of the essential information they can provide via rapid, non-destructive measurements.

The pharmacopoeia said technological developments in the Raman Spectroscopy field prompted the revision of the current chapter. Such updates focused on aspects that enhance the reliability of the results, and particularly in the event that Raman spectroscopy is intended to be used as an alternative to infrared (IR) spectroscopy for release.

The following modifications were made to the current chapter, alongside several editorial improvements:

  • the section on the response-intensity scale has been updated;
  • a section on spectral resolution using calcium carbonate has been introduced. It is acknowledged that the spectral resolution is an essential performance parameter for Raman Spectroscopy. For identity tests, a tolerance of maximum 15 cm-1 is prescribed, unless otherwise prescribed in a monograph;
  • procedures for the comparison of spectra have been described.

Moreover, the revisions are designed to draw the user’s attention to the importance of aspects such as access to data, spectra in particular, and to any verifications, instrument settings and measurement parameters. More generally, said Ph. Eur. Raman measurement details should be readily accessible, manageable and understandable.

The revised chapter will be published in Ph. Eur. Supplement 10.7, available in October 2021.

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