Using FT-IR To Identify Unknown Contaminants

By Alan Xu and Chiara De Zorzi

Modern pharmaceutical supply chains involve a complex series of steps, from selecting and processing drug containment systems to the actual manufacturing of the drug product. Each step presents potential opportunities for mistakes or unforeseen issues. To ensure a swift and effective quality investigation, pinpointing the exact source of the problem is essential.

Stevanato Group's Technology Excellence Center (TEC) has extensive experience collaborating with pharmaceutical companies and contract manufacturers of all sizes. TEC utilizes forensic techniques to pinpoint problems and then test potential solutions to minimize disruption and expedite a confident return to market.

This paper delves into two case studies where TEC employed Fourier Transform Infrared Spectroscopy (FT-IR) to assist clients in identifying contaminants. These contaminants can be extrinsic, originating from particles or fibers introduced during handling, or intrinsic, arising from the drug product or its source material itself.

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