AS208: High-Throughput Residual Solvent and Residual Monomer Analysis Using Selected Ion Flow Tube Mass Spectrometry (SIFT-MS)

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High-Throughput Residual Solvent and Residual Monomer Analysis Using Selected Ion Flow Tube Mass Spectrometry (SIFT-MS):

Residual solvent and monomer testing are analyses that are widely conducted in the pharmaceutical and food industries to comply with regulations and ensure the quality and safety of the final products.

Currently, the most widely used methods for this type of analyses are chromatographic. However, these can be slow, and often require extensive sample preparation and derivatisation prior to injection. A number of different methods may be required to cover the necessary range of compounds.

Whilst formaldehyde can be difficult to analyse using gas chromatography, a SIFT-MS approach removes the need for any derivatisation and the speed with which SIFT-MS analyses a sample can greatly increase throughput. A number of compounds were analysed simultaneously including challenging species such as ammonia and formaldehyde alongside solvents such as benzene and toluene. All 13 compounds were monitored in 90 seconds.

Questions can also be asked regarding the total amount of a given monomer that is present in the final solid product (rather than from a single measurement of headspace).  SIFT-MS coupled to an autosampler can answer this question quickly using multiple headspace extraction.

This application note demonstrates the ability of high-throughput SIFT-MS to provide rapid, mass-screening of products for residual solvents would could significantly improve QA/QC processes in the pharmaceutical industry. This approach could potentially be implemented on an existing conveyor system, contributing to the strive towards continuous manufacturing processes.

 

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