Extractables & Leachables Analysis Solutions

Extractables & Leachables Analysis Solutions

Undertake complete extractables and leachables analysis to meet stringent regulatory limits with Waters comprehensive analytical solutions. From untargeted screening and characterization to quantitation and reporting, Waters is committed to supporting the safety of your products with the utmost confidence in your results.

Undertake complete extractables and leachables analysis to meet stringent regulatory limits with Waters comprehensive analytical solutions. From untargeted screening and characterization to quantitation and reporting, Waters is committed to supporting the safety of your products with the utmost confidence in your results.
Closeup pink-white and blue-white antibiotics capsule pills in blister pack
Closeup pink-white and blue-white antibiotics capsule pills in blister pack

Overview


Consumer safety can be negatively impacted by chemical compounds migrating from products. Regulations are in place for industries in which the exposure routes are of higher risk, such as pharmaceuticals, medical devices, foodstuffs and cosmetics. Testing for these contaminants is commonly known as an Extractables & Leachables study. 

To ensure regulatory compliance, avoid product recalls, and protect their brands, organizations must carefully control and monitor their products to eliminate the potential risks associated with extractables and leachables. Partnering with Waters means you can make critical decisions – in less time and with greater confidence by leveraging powerful technologies that are specifically designed to improve your workflow, increase testing throughput, and support compliance reporting. Our continually updated E&L library contains useful information on product ions, retention time, and collision cross section values to increase your confidence in the identification of unknowns.

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Applications

Drug containers and modern drug delivery systems are meant to protect a drug from environmental contamination, but can themselves be a source of contamination. Learn how we help pharmaceutical manufacturers ensure materials safety considerations are met with these application notes.

Drug containers and modern drug delivery systems are meant to protect a drug from environmental contamination, but can themselves be a source of contamination. Learn how we help pharmaceutical manufacturers ensure materials safety considerations are met with these application notes.

Application Notes

Application Notes

Characterization of food contact materials and identification of Non-Intentionally Added Substances (NIAS) is becoming more critical due to increasing global regulations designed to support adequate safety of foodstuffs; along with a demand for increased use of more sustainable packaging. Learn how Waters provides comprehensive support to ensure the safety considerations of your packaging material are met with these application notes.

Characterization of food contact materials and identification of Non-Intentionally Added Substances (NIAS) is becoming more critical due to increasing global regulations designed to support adequate safety of foodstuffs; along with a demand for increased use of more sustainable packaging. Learn how Waters provides comprehensive support to ensure the safety considerations of your packaging material are met with these application notes.

Application Notes

Application Notes

Whether you are a materials supplier or medical device manufacturer, regulations require E&L analysis to identify potentially harmful substances that may be released from medical device materials or components. Learn how we support medical device manufacturers who are committed to patient safety with these application notes.

Whether you are a materials supplier or medical device manufacturer, regulations require E&L analysis to identify potentially harmful substances that may be released from medical device materials or components. Learn how we support medical device manufacturers who are committed to patient safety with these application notes.

Application Notes

Application Notes

Polymer additives, stabilizers, coloring dyes, and other chemicals pose a contamination risk for cosmetic products. From production processes to packaging processes, find out how Waters can help you obtain accurate, reproducible results to ensure that no non-intentionally added compound finds its way into your product with these application notes.

Polymer additives, stabilizers, coloring dyes, and other chemicals pose a contamination risk for cosmetic products. From production processes to packaging processes, find out how Waters can help you obtain accurate, reproducible results to ensure that no non-intentionally added compound finds its way into your product with these application notes.

Application Notes

Application Notes

Case Study: Safety Challenges of Incorporating Recycled Plastics in Food Contact Materials

While plastics have many valuable uses, consumption of plastics products has wrought significant environmental and health consequences. This case study describes combined research work from University of Zaragoza in Spain and Waters to determine the most suitable analytical workflow for identification and quantification of unknown compounds in food contact materials.

While plastics have many valuable uses, consumption of plastics products has wrought significant environmental and health consequences. This case study describes combined research work from University of Zaragoza in Spain and Waters to determine the most suitable analytical workflow for identification and quantification of unknown compounds in food contact materials.
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Salads in modified atmosphere packaging (MAP)

Solutions

With Waters systems, identify components from the most complex formulations in less time and with greater confidence.

With Waters systems, identify components from the most complex formulations in less time and with greater confidence.

Complete coverage for confident characterization

Complete coverage for confident characterization
Xevo G3 QTof Mass Spectrometer

Perform confident identification of E&L components in complex matrices with the Xevo G3 QTof. MSE, a data independent acquisition, ensures accurate identifications when screening against a library and provides additional information to aid structural elucidation.

  • Pharmaceutical
  • Food Contact Materials
  • Medical Devices
  • Cosmetics

Endless possibilities. Limitless research.

Endless possibilities. Limitless research.
SELECT SERIES Cyclic IMS

Achieve high confidence in identification of unknowns in complex mixtures using cyclic ion mobility with high-resolution mass spectrometry (HRMS). Unparalleled separation by shape and m/z with measurement of the Collisional Cross Section (CCS).

  • Pharmaceutical
  • Food Contact Materials
  • Medical Devices
  • Cosmetics

Identification of unknown volatiles

Identification of unknown volatiles
Waters Atmospheric Pressure Gas Chromatography (APGC)

Increase your compound coverage to include identification of unknown volatiles with Waters Atmospheric Pressure Gas Chromatography (APGC), interfacing GC to existing Waters HRMS.

  • Pharmaceutical
  • Food Contact Materials
  • Medical Devices
  • Cosmetics

Ultimate sensitivity for quantitative analyses

Ultimate sensitivity for quantitative analyses
Xevo TQ Absolute Triple Quadrupole Mass Spectrometry

Waters Xevo TQ Absolute Triple Quadrupole Mass Spectrometry delivers unprecedented levels of reliability, reproducibility, and performance for your quantification of leachables & chemicals of concern.

  • Pharmaceutical
  • Food Contact Materials
  • Medical Devices
  • Cosmetics

The next evolution in separation science is here

The next evolution in separation science is here
ACQUITY Premier System

Maximize the sensitivity, repeatability, and robustness of your LC and LC-MS applications with the ACQUITY Premier System, featuring MaxPeak High Performance Surfaces (HPS) Technology for improvements in separation and detection to minimize the risk of undetected analytes.

  • Pharmaceutical
  • Food Contact Materials
  • Medical Devices
  • Cosmetics

Delivering SmartMS to the masses

Delivering SmartMS to the masses
ACQUITY RDa Detector

Increase productivity, improve data confidence and simplify routine accurate mass workflows with the ACQUITY RDa Detector for easy access to high resolution mass measurements.

  • Pharmaceutical
  • Food Contact Materials
  • Medical Devices
  • Cosmetics

Quantify high- and low-level components at once within a single chromatographic separation

Quantify high- and low-level components at once within a single chromatographic separation
ACQUITY UPLC PDA Detector

Obtain advanced optical detection perfect for routine analyses with the ACQUITY UPLC Photodiode Array (PDA) Detector that provides unprecedented trace impurity detection and quantitation with spectral analysis capabilities, from compound identification to method development.

  • Pharmaceutical
  • Food Contact Materials
  • Medical Devices
  • Cosmetics

Waters software streamlines data acquisition, processing, and reporting E&L analysis results.

Waters software streamlines data acquisition, processing, and reporting E&L analysis results.

Simplify the screening workflow for extractables testing

Simplify the screening workflow for extractables testing
waters_connect for Small Molecule Workflows

Identify the structural elucidation of unknown compounds above the analytical evaluation threshold in less time with Waters UNIFI Application within the waters_connect platform, offering a simple workflow that includes scientific library creation, untargeted screening, multivariate statistical analysis, structural elucidation tool kit, and reporting.

  • Pharmaceutical
  • Food Contact Materials
  • Medical Devices
  • Cosmetics

Our full range of columns and consumables can be easily integrated into your chromatography and mass spectrometry workflows.

Our full range of columns and consumables can be easily integrated into your chromatography and mass spectrometry workflows.

Increase speed, sensitivity, and resolution without compromising data integrity

Increase speed, sensitivity, and resolution without compromising data integrity
ACQUITY UPLC Columns

Discover increases in LC efficiency, resolution, sensitivity, accuracy, speed, and reliability with ACQUITY sub-2-μm UPLC particle columns for your E&L analyses.

  • Pharmaceutical
  • Food Contact Materials
  • Medical Devices
  • Cosmetics

Simplify your screening workflow

Simplify your screening workflow
Extractables & Leachables Screening Standard

Designed to complement the Waters Screening Platform Solution with Waters UNIFI Application, the Extractables & Leachables Screening Standard is composed of 18 common polymer additives to evaluate and benchmark high-resolution LC-MS systems.

  • Pharmaceutical
  • Food Contact Materials
  • Medical Devices
  • Cosmetics

Maximize efficiency with fewer failed assays and lower instrument downtime

Maximize efficiency with fewer failed assays and lower instrument downtime
Standard & Certified HPLC Sample Vials

Achieve specified levels of cleanliness, controlled pH shifts, and adsorptive losses - from batch to batch and vial to vial using Waters Certified vials for your E&L analyses.

  • Pharmaceutical
  • Food Contact Materials
  • Medical Devices
  • Cosmetics

Minimize sample loss for MS, LC, and GC applications

Minimize sample loss for MS, LC, and GC applications
TruView pH Control LCMS Certified Vials

Analyze sample concentrations of ≤1 ng/mL effectively using TruView LCMS Certified Vials, the ideal choice for your E&L applications.

  • Pharmaceutical
  • Food Contact Materials
  • Medical Devices
  • Cosmetics

Achieve testing efficiencies and accurate results using streamlined Waters services and support.

Achieve testing efficiencies and accurate results using streamlined Waters services and support.

Your success is just a click away

Your success is just a click away
Waters Global Services

Optimize your laboratory's productivity and success with Waters Global Services. Maintain peak system performance, minimize downtime, address application challenges, and support stringent compliance requirements.

  • Pharmaceutical
  • Food Contact Materials
  • Medical Devices
  • Cosmetics

Make science more accessible 

Make science more accessible 
Payment Solutions

Maximize resources and minimize risk with payment options from Waters Capital, including upgrading aging equipment, getting customized support, and bundling services into one monthly payment.

  • Pharmaceutical
  • Food Contact Materials
  • Medical Devices
  • Cosmetics

The data speaks for itself

The data speaks for itself
A complete extractables analysis workflow can be undertaken using the Waters UNIFI Application within the waters_connect Software Platform. The workflow can be customized to meet user requirements and streamline the analysis of complex datasets. Shown in the figure is the component summary table for each analyte in the Waters E&L SST mix, the extracted ion chromatogram for Irganox 245, and a summary plot of retention times for this analyte across all injections.
APGC provides softer ionization resulting in molecular ion detection. Combined with MSE, a data independent acquisition mode, the simultaneous acquisition of the accurate mass information of both precursor and fragment ions is enabled. This information is key for confident screening of extractables and for the structural elucidation of unknowns to ultimately aid full compounds coverage.
The Waters UNIFI Application elucidation toolkit can be used for the tentative identification of unknown peaks using the accurate mass and fragmentation data. Results include the predicted elemental composition, i-FIT confidence (isotopic pattern algorithm used to score each formula), common name for the compound, number of fragment matches, and the number of citations. Synonyms, structure, and high energy spectrum for this compound are also displayed. 
The Waters UNIFI Application within the waters_connect Software Platform can be used for quantitation for an extractables and leachables analysis. Calibration curves can be included in an analysis to calculate the concentration of compounds present in unknown samples.

Webinars and Resources

  • Application Notebook

Extractables, Leachables and Food Contact Materials Application Notebook

Extractables, Leachables and Food Contact Materials Application Notebook
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  • eBook

Medical Devices Regulatory Pathway eBook

Medical Devices Regulatory Pathway eBook
Download
  • Infographic

Simplifying the Screening Workflow for Extractables Testing

Simplifying the Screening Workflow for Extractables Testing
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  • Infographic

Screening for Safety: Assessing Recycled Plastic Intended for Food Packaging Use Infographic

Screening for Safety: Assessing Recycled Plastic Intended for Food Packaging Use Infographic
Download
  • White Paper

Medical Device Material Development: Considerations to Minimize Extractables and Leachables White paper

Medical Device Material Development: Considerations to Minimize Extractables and Leachables White paper
Download
  • White Paper

Medical Devices: An Evolving Regulatory Landscape

Medical Devices: An Evolving Regulatory Landscape
Download
  • On Demand Webinar

LC-MS Method Development for Analysis of Extractable Compounds in Plastic Containers

LC-MS Method Development for Analysis of Extractable Compounds in Plastic Containers
Download

Related

Medical Device Materials
Characterize, optimize, and validate medical device performance and safety with the rigorous testing and precise, reliable instrumentation provided by Waters. From initial concept to final product, our solutions ensure comprehensive characterization and optimization at every stage of development.​
Closeup pink-white and blue-white antibiotics capsule pills in blister pack
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