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Business & Regulation Standards & Regulation, Technology and Equipment, Analytical Science, Dosage Forms

Fast, Non-destructive Solid-State Testing

This article was published in our sister publication, The Small Molecule Manufacturer, which celebrates the field of small molecule drug development and manufacturing with interviews and articles focusing on success stories, equipment, and new processing techniques. Read more about The Small Molecule Manufacturer here

Lee Dowden, Product Manager for Agilent’s TRS100, worked in various analytical roles in the pharma industry – including product release testing, method development, stability testing, cleaning validation, and instrument validation – before entering the equipment industry. We catch up with him to find out how transmission Raman spectroscopy (TRS) works.

How is TRS used?

Laboratory techniques for the analysis of solid dosage forms have traditionally relied upon extraction of the API followed by chromatographic separation – either high-performance liquid chromatography or gas chromatography. Although advances have been made in these techniques, they have not fundamentally changed and tend to rely on time-consuming solvent extraction, which also creates a significant amount of waste. Spectroscopic solutions, such as near infrared spectroscopy, can help overcome some of the issues associated with chromatography, but still have limitations. TRS was developed to overcome key pain points and technological concerns.

TRS is a variant of traditional Raman spectroscopy that is particularly well suited to analyzing bulk content, including tablets and powder samples. It can be used for both formulation development and finished product testing. TRS only became commercially available around 10 years ago, with the launch of Cobalt Light System’s TRS100 instrument. Cobalt was founded in 2008 as a spin-out from the UK Science and Technology Facilities Council (STFC), and developed technologies from the research and innovations of Prof. Pavel Matousek, a senior fellow at STFC, into commercial products for non-invasive analysis. The TRS100 was the first product to be launched by the company. Cobalt is now part of Agilent’s Molecular Spectroscopy division.

TRS is a fast (typical analysis time of 10–60 seconds), non-destructive analytical test, with no sample preparation or solvent use, and is used in pharma QC labs for a variety of applications, including polymorph determination, analyzing crystalline content in amorphous dispersions, excipient compatibility assessments for formulation development, content uniformity testing, and at-line, in-process testing. 

The TRS100 automates the qualitative and quantitative analysis of large samples (>100 at a time) of pharmaceutical dosage forms with fast measurement times. It can reduce content uniformity, assay, and ID tests from hours, or even overnight, to minutes per batch, cutting costs significantly and speeding up the quality control workflow.

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