Raman is a vibrational spectroscopic technique and is complementary to IR and NIR. Raman has a broad applicability in the pharmaceutical industry from manufacturing and R&D, in-line process monitoring to polymorph screening along with incoming raw material ID testing. Not all components of USP are relevant for qualitative analysis, especially the chemical elements related to identity testing. Also, the general chapter was written at a time when typical manually configurable R&D Raman systems were available.
Nowadays, it is often used for the inspection of incoming active ingredients and excipients. The recent introduction (August 2020) of USP <858> demonstrates Raman spectroscopy’s growing importance in the pharmaceutical sector. The USP <1120> general chapter was originally introduced in March 2016 and went through numerous changes. Raman chapters USP <858> “Raman Spectroscopy” and USP <1858> “Raman Spectroscopy–Theory and Practice” are to replace USP <1120> “Raman Spectroscopy.” USP <858> is a monograph including USP chapters under <1000> that are not just informational but enforceable by the USFDA.
Bruker Optics offers the BRAVO, an exceptional handheld portable Raman spectrometer suitable for the new USP <858> regulation along with 21CFR11 compliance for data integrity in validated environments.