Raman Spectroscopy in the USP

GMP News
12 September 2007

Raman Spectroscopy in the USP

Part of the published second Supplement to the US Pharmacopoeia USP 30 (2007) is a revision of the General Chapter <1120> which also describes Raman Spectroscopy. In addition to a general introduction to the measuring principles, the chapter also covers the following topics in more detail:

  • Possible measurements: qualitative and quantitative
  • Factors influencing the quantitative measurements
  • Design of Raman measuring devices
  • Calibration of Raman Instruments
  • Qualification and Validation
  • Method Validation

Implementing this chapter into the US Pharmacopoeia in the past year and revising it this year certainly facilitates the application of Raman Spectroscopy in the pharmaceutical industry as well as ist acceptance in authorities.

The application of Raman Spectroscopy in the manufacture of APIs and as PAT tool will be introduced in two presentations at the Heidelberg PAT Conference 2007. This conference is organised in cooperation with the University of Heidelberg and concentrates on "PAT Applications of NIR and other Spectroscopy Systems in Pharmaceutical Development and Manufacture". It will take place from 24-26 October in Heidelberg, Germany. To find out more, please visit www.pat-conference.org.

Dr. Günter Brendelberger
On behalf of the European Compliance Academy (ECA)

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