At its 169th session (March 2021), the European Pharmacopoeia (Ph. Eur.) Commission adopted revised chapter 2.2.48 on Raman Spectroscopy.
Raman spectrometers are increasingly deployed in the pharmaceutical environment. Their interfaces are user-friendly and they can provide essential information about a sample via rapid, non-destructive measurements.
Technological developments in the field have prompted revision of the current chapter, focusing on aspects that enhance the reliability of the results, in particular if Raman spectroscopy is intended to be used as an alternative to IR spectroscopy for release.
The following modifications were made to the current chapter, as well as 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 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 attention of users has been drawn to the importance of aspects such as access to data, spectra in particular, and to any verifications, instrument settings and measurement parameters. More generally, 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.