Revised Ph. Eur. Raman Spectroscopy Chapter published for Public Consultation

Monoclonal Antibodies - From Concept to Approval

Recommendation

20/21 May 2025
Vienna, Austria

Monoclonal Antibodies - From Concept to Approval
With a workshop about the development of ADCs

Raman spectroscopy is a non-destructive vibrational spectroscopic technique. The sample is irradiated with an intense monochromatic light source, usually a laser. Raman spectrometers are increasingly deployed in the pharmaceutical environment.

Due to recent technological developments in the field of Raman spectroscopy, an update of the European Pharmacopoeia (Ph. Eur.) chapter 2.2.48 on Raman Spectroscopy has become necessary. Thus, "the general chapter has been updated in view of the latest developments. This general revision mainly includes:

an update on the section on response-intensity scale;
a new section on spectral resolution, using calcium carbonate;
a description of procedures for the comparison of spectra."

According to a press release dated 22 June 2020 "the attention of users has been drawn to the necessity to preferentially select instruments enabling access to data, spectra, control and measurement settings in general. Raman measurement details should be accessible, manageable and understandable."

The revised chapter is published in Pharmeuropa 32.3 for public consultation from July to September 2020. All interested users are strongly encouraged to review the draft and submit their comments.

The draft version is available as a PDF-file (login required - register for free).