Whitepaper: Enhanced Raman reflection spectroscopy for process analytical technology

1 December 2015  •  Author(s): Kaiser Optical Systems, Inc

The Process Analytical Technology (PAT) initiative from the U.S. Food and Drug Administration (FDA) encourages pharmaceutical manufacturers to employ real-time analytical tools for detailed understanding of their processes.

Kaiser-whitepaper-front-coverThis serves two purposes: to enable real-time process control and to promote detailed process understanding for flexible quality control during the course of the process rather than only by analyzing the end product.

The development of techniques for real-time process analysis is a significant focus of recent work in pharmaceutical technology and analytical chemistry. Vibrational spectroscopic methods such as nearinfrared (NIR) spectroscopy and Raman spectroscopy have gained favor because they can be deployed in a non-contact mode, and they give detailed chemical information with great potential for robust modeling. Raman has proven to be especially useful in pharmaceutical process monitoring because it is not obstructed by the presence of water, which is a significant problem for infrared spectroscopies, and because it usually requires little to no sample preparation.

Of particular utility in pharmaceutical processing is the ability to analyze the entire depth of a complex layered solid simultaneously. This note describes the use of enhanced Raman reflection spectroscopy to accomplish this analysis on multi-layered samples similar to many pharmaceutical tablets. This work underpins current applications in the pharmaceutical industry.

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