title: Rationale for the update of the European Pharmacopoeia general chapter 2.2.48. Raman spectroscopy.
abstract: Raman spectroscopy technique is widely used for the identification and characterisation of materials in the laboratory environment and, increasingly, for off-line, at-line, in-line and online Process Analytical Technologies (PAT) applications. The wide range of currently available Raman technologies had led to the requirement to update the existing General Chapter 2.2.48. The purpose of this reflection paper is to explain the rationale behind the establishment of the new wavenumber scale standards and peak position tolerances resulting from a multi-site, multi-instrument, inter-laboratory study of standards and, in particular, to discuss the results obtained with microscopes (including multi-point calibration) by the PAT Working Party.
authors.affiliation: GSK, United Kingdom.
authors.forename: I R
authors.initials: IR
authors.lastname: Lynch
authors.affiliation: Sandoz GmbH, Austria, walter.schuh@sandoz.com.
authors.forename: W
authors.initials: W
authors.lastname: Schuh
authors.affiliation: Reutlingen Research Institute, Reutlingen University, Germany.
authors.forename: W
authors.initials: W
authors.lastname: Kessler
mesh_terms: D002138:Calibration; D002626:Chemistry, Pharmaceutical / Q000379:methods / Q000592:standards*; D005060:Europe; D010602:Pharmacopoeias as Topic / Q000592:standards*; D013059:Spectrum Analysis, Raman / Q000379:methods / Q000592:standards*
keywords: PAT; Raman Spectroscopy; instrument verification; wavenumber tolerance