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Spectroscopy PharmTech Whitepaper - Implementing Transmission Raman Spectroscopy for Fast Content Uniformity Testing: From Feasibility Evaluation to a

Spectroscopy PharmTech Whitepaper - Implementing Transmission Raman Spectroscopy for Fast Content Uniformity Testing: From Feasibility Evaluation to a

Pages 8 Pages

SPONSORED BY Implementing Transmission Raman Spectroscopy for Fast Content Uniformity Testing: From Feasibility Evaluation to a Validated Release Method An Executive Summary W hen considering a new analytical technology in the pharmaceutical industry, the major considerations typically revolve around two questions: Is there a good business case for it, and what are the regulatory consequences? What follows are the results of an evaluation that led to the implementation of transmission Raman spectroscopy (TRS) for content uniformity testing at Grünenthal Pharma in Germany. In the end, it was not only the financial benefit, but also the stakeholder enthusiasm that convinced management of the need to invest in new technology for a standard test requirement. Introduction The approach

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