Per- and polyfluoroalkyl substances (PFAS) are now well known for their persistence and damaging effects on the human body, and their presence is monitored carefully in water and food supplies.
However, there is currently no regulatory guidance on PFAS levels in pharmaceutical products, which could compromise safety and efficacy. For medical device and pharma companies, proactivity is essential to be ready for future regulations and develop risk mitigation strategies.
This application note assesses an LC-MS strategy for testing manufacturing components for PFAS, even at sub-ppb levels, ensuring reliable results.
Download this application note to discover:
- One LC-MS method that provides PFAS-specific and general extractable screening
- How to minimize background interference for confident results
- A 21 CFR Part 11 compliance-ready solution for data analysis and acquisition
Extractables and leachables
(E&L) analysis
PFAS screening in pharmaceutical packaging
and medical devices
For Research Use Only. Not for use in diagnostic procedures. © 2025 Thermo Fisher Scientific Inc. All rights reserved. All
trademarks are the property of Thermo Fisher Scientific and its subsidiaries unless otherwise specified. FL003856 0525
Learn more at thermofisher.com/byyourside
PFAS (Per- and polyfluoroalkyl substances) are widely recognized for their
persistence in the environment and potential health risks, prompting strict
regulatory actions in industries such as food and water safety. However, the
pharmaceutical sector currently lacks clear regulatory guidelines on PFAS levels
in drug products and medical devices, making proactive detection and risk
mitigation essential to ensure product safety and compliance.
Comprehensive solution
• Combined targeted quantitation and non-targeted screening
for PFAS compounds from one injection is achieved.
• One LC-MS method provides both PFAS-specific and general
extractables screening
Added value
• Targeted analysis of a list of PFAS compounds yields
unequivocal identification and quantification down to sub-ppb
levels.
• Non-targeted analysis reveals additional PFAS contaminants
in the sample extracts that could be quantified using
surrogate standards.
• Use of the PFAS analysis kit and delay column minimizes
background interference and increases confidence in the
analytical results.
• Use of Thermo Scientific™ Chromeleon™ CDS provides a 21
CFR Part 11 complianceready solution for data acquisition
and quantitative analysis in extractables screening.
Thermo Scientific™
Hypersil GOLD™
VANQUISH™ C18
UHPLC Column
Thermo Scientific™ Vanquish™ UHPLC System
with Diode Array Detection (DAD) with
Thermo Scientific™ Orbitrap Exploris 120 MS
Thermo Scientific™ Chromeleon™ Chromatography Data System (CDS)
Thermo Scientific™ Compound Discoverer™ software Thermo Scientific™
mzCloud™ database for E&L, molecule high-resolution accurate mass
(HRAM), and MS library searching
