Extractables and Leachables Analysis Applications

Applications for extractables and leachables analytical testing

Extractables and leachables (E&L) testing is critical for ensuring the safety and compliance of pharmaceutical packaging and medical devices. Key applications in E&L analysis include: non-volatile compound workflows, volatile compound workflows, PFAS detection in packaging and medical devices, and elemental impurity analysis. Leveraging Thermo Fisher Scientific’s innovative instrumentation—such as high-resolution mass spectrometry (HRAM), gas chromatography-mass spectrometry (GC-MS), and inductively coupled plasma-mass spectrometry (ICP-MS)—our solutions provide the sensitivity, accuracy, and regulatory compliance needed for robust E&L workflows.​

Non-volatile compound workflows

Non-volatile compound workflows identify high-molecular-weight, thermally stable extractables from packaging, medical devices, and biopharmaceutical components. Using liquid extraction techniques like accelerated solvent extraction (ASE) and LC-MS or UHPLC-HRMS, these workflows detect polymeric additives, oligomers, and degradation products. Thermo Scientific Orbitrap HRMS and Thermo Scientific Vanquish UHPLC systems provide high sensitivity and compliance, helping to ensure product safety and regulatory adherence​.

Confident extractable testing of medical device components using a new automated parallel extraction and evaporation sample preparation system and the multidetector approach

This application note demonstrates the use of the Thermo Scientific EXTREVA ASE Accelerated Solvent Extractor, which enables parallel solvent extraction and automated evaporation, streamlining the analysis of a polypropylene medical device component for unknown extractables.​

PFAS in pharmaceutical packaging and medical devices

Per- and polyfluoroalkyl substances (PFAS) are widely used in pharmaceutical packaging and medical devices due to their durability and chemical resistance, but their potential to leach into drug products raises safety concerns. Detecting PFAS requires sensitive analytical techniques such as LC-MS/MS and high-resolution mass spectrometry (HRMS) to identify and quantify these persistent contaminants at trace levels. Thermo Scientific Orbitrap HRMS and triple quadrupole LC-MS systems offer high precision and regulatory-compliant workflows for PFAS analysis, helping to ensure product safety and compliance with evolving guidelines.​

Comprehensive PFAS screening in pharmaceutical packaging and medical devices by LC-HRAM-MS

PFAS contamination poses a potential risk in pharmaceutical and medical device materials, yet regulatory guidance remains limited. This application note presents an LC-MS-based analytical strategy for detecting PFAS in extractables screening, demonstrated through the analysis of fluorine-containing polymer components in collaboration with SGS Health Science​.

Volatile compound workflows

Volatile extractables, such as residual solvents and monomers, can migrate from packaging and medical devices, posing risks to drug stability. HS-GC-MS, using Thermo Scientific TriPlus 500 Headspace Autosampler and Thermo Scientific Orbitrap GC-MS, enables sensitive, high-resolution detection to help ensure compliance and product safety.​

Analytical solutions for challenges in headspace GC-MS analysis of volatile extractable and leachable compounds

Pharmaceutical products interact with various polymeric materials that may release harmful extractables and leachables, posing risks to drug stability and patient safety. This application note presents an optimized headspace GC-MS method using the Thermo Scientific TriPlus 500 Headspace Autosampler and Thermo Scientific Orbitrap GC-MS/FID, providing high sensitivity and selectivity for detecting volatile impurities in complex matrices​.

Elemental impurities

Elemental impurities from packaging, manufacturing components, or drug formulations can pose toxicity risks and require strict regulatory compliance. Inductively coupled plasma mass spectrometry (ICP-MS) and inductively coupled plasma optical emission spectroscopy (ICP-OES) are the gold standard for detecting trace metals in pharmaceutical products. Thermo Scientific iCAP ICP-MS OES systems provide high sensitivity and accuracy, helping to ensure compliance with ICH Q3D guidelines for elemental impurity analysis in E&L studies.

Analysis of elemental impurities in drug products using the Thermo Scientific iCAP 7400 ICP-OES Duo

Monitoring impurities, both organic and inorganic, is crucial to ensure drug safety and stability. This application note discusses the recent USP proposal to replace General Chapter <231> for heavy metals with two new chapters, offering updated guidelines for impurity testing in pharmaceutical products.​

For Research Use Only. Not for use in diagnostic procedures.