Revision of the USP chapter on Raman

Recommendation

23-25 May 2023
Vienna, Austria

Analytical Instrument Qualification
Practical Approaches for USP General Chapter <1058> Compliance in the QC Laboratory

Raman is a vibrational spectroscopic technique and is complementary to IR and NIR. Nowadays, it is often used for the inspection of incoming active ingredients and excipients.

The USP's new suggestions for chapter <858> - Ramen Spectroscopy were published in the Pharmacopeial Forum (PF) 42(2) from March/April 2016.

The previous proposal has been revised due to the received comments - a number of them asking about precise specifications for multivariate calibrations since the earlier version of this chaper had only concentrated on univariate approaches.

Furthermore, a reference to the new USP chapter <1039> - Chemometrics has now been established. The Chapter has since been made official and contains multivariate calibrations, as well.

The USP had also taken a look at European Pharmacopoeia General Chapter 2.2.48 on Raman Spectroscopy before introducing Raman handhelds into the USP chapter.

Furthermore, the chapters on quantitation limit and linearity have been revised. Also, the table for checking wavelength accuracy has been supplemented by the acceptance criteria for reference materials (polystyrene, paracetamol and cyclohexane).

On the USP website of the Pharmacopeial Forum PF, 42(2) you can find more information on the revision of the General Chapter <858> Raman Spectroscopy.