Advancing PFAS Detection in Pharmaceutical Manufacturing with LC-HRAM-MS

In the realm of pharmaceutical manufacturing, the detection and analysis of perfluoroalkyl substances (PFAS) have become a growing source of concern due to their persistence and potential health risks. The latest application note from SGS presents a groundbreaking approach to PFAS screening and quantification, leveraging the capabilities of the Thermo Scientific Vanquish UHPLC and Orbitrap Exploris 120 high-resolution mass spectrometer (HRAM-MS).

This application note demonstrates the sensitive detection and identification of both known and unknown PFAS compounds in extracts from common pharmaceutical manufacturing and packaging materials. By employing a combined targeted and non-targeted approach, the study highlights how the integration of the Vanquish UHPLC and Orbitrap Exploris 120 HRAM-MS can revolutionize PFAS analysis.

The key benefits of this method include:

• Combined Targeted and Non-Targeted Screening: One injection allows for both the quantitation of specific PFAS compounds and the screening for additional, previously unidentified PFAS contaminants.
• Enhanced Analytical Confidence: The use of a PFAS analysis kit and delay column minimizes background PFAS interference, thereby increasing the reliability of the results.
• Regulatory Compliance: Utilizing Chromeleon CDS ensures that the data acquisition and quantitative analysis comply with 21 CFR Part 11, a crucial requirement for pharmaceutical applications.
• High Sensitivity and Specificity: The method provides unequivocal identification and quantification of PFAS compounds down to sub-ppb levels.

The study underscores the efficacy of the Orbitrap Exploris 120 HRAM-MS in providing a comprehensive solution for PFAS analysis. By integrating both targeted and non-targeted approaches, this method not only enhances the detection sensitivity and specificity but also expands the scope of detectable PFAS contaminants. This dual approach is a significant advancement in extractables screening, offering pharmaceutical manufacturers a robust tool for ensuring the safety and compliance of their products.

This collaboration between SGS and Thermo Fisher Scientific illustrates a leap forward in PFAS screening technology, promising higher quality results, increased confidence, and regulatory compliance in the pharmaceutical manufacturing process.