Reliably and cost-effectively identify and quantify extractable, leachable, and NIAS compounds across the research and development and commercialization workflows.

The safety of pharmaceuticals, foodstuffs, cosmetics, and medical devices may be compromised by chemical compounds in the food contact materials (FCMs), packaging that is in direct contact with the consumer product or materials and coatings used in the manufacturing of medical devices. These chemical compounds are typically categorized as Extractables, Leachables, and Non-Intentionally Added Substances (NIAS).

Due to continuously increasing global regulations and safety requirements, the characterization and testing for specific chemical compounds has become more critical than ever for the manufacturers that supply the pharmaceutical, food, cosmetics, and medical device industries. To ensure regulatory compliance, avoid product recalls and protect their brands, organizations in these industries must carefully control and monitor their products to eliminate the potential risks associated with extractable, leachable and NIAS compounds.

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.

Adressing E&L challenges with Waters Solutions

Waters provides key solutions that can effectively:

• Maximize separation for complex samples reliably and routinely
• Obtain the highest level of structural information that reveals even trace amount of compounds
• Visualize, process, and report data more effectively to support compliance documentation
• Make critical decisions in less time with greater confidence using tools and techniques to improve workflow and increase testing throughput.

Waters Extractables & Leachables new educational resources

E&L European Forum 2022 - Now available on-demand

Waters E&L forum offers a unique opportunity for leading E&L experts and decision makers to discuss the latest updates on regulations in the field of food, pharma, biopharma and medical devices, targeted and non-targeted screening workflow, chromatographic techniques, extraction methods and analytical standards & reagents, and much more. 

Discover all the work presented now on-demand, from the comfort of your home, office or lab!

Medical Devices Webinar Series, now on-demand

This webinar series provides professional expertise and technical assistance on the development, testing and regulatory compliance of medical devices. Discover all the work presented, from the comfort of your home, office or lab! Hear about topics such as Chemical Characterization of Medical Devices, Fatigue and Durability testing or Rheology and Thermal Characterization of Medical Devices.

Medical devices: regulations and chemical characterisation - A Chemistry World webinar

Join Dr Andrew Feilden for a discussion on medical device regulations and updates to extractable and leachable analysis requirements (ISO 10993-18).

High Resolution Mass Spectrometry (HRMS) strategies for targeted and untargeted screening of printing inks in extractable studies - A Waters webinar

During this webcast, Caitlyn Da Costa will discuss how to use High Resolutions Mass Spectrometry (HRMS) strategies for screening of both targeted and untargeted printing inks.

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

In this webinar, we will focus on the development of appropriate method to separate 18 polymer additives routinely monitored in extractables and leachables (E&L) workflows.

Download our resource kits and get valuable information regarding your market industry

Producer, manufacturer or expert in the food industry?

Download our FCM resource kit, and learn how Waters provides comprehensive support to the food industry to ensure the safety considerations of your packaging material are met.

Producer, manufacturer or expert in the pharmaceutical or medical devices industry?

Access your essential Pharmaceutical and Medical Devices E&L resource kit to learn how Waters can help you overcoming your challenges in the extractables and leachables testing.

Producer, manufacturer or expert in the cosmetics industry?

Download our cosmetics resource kit, and find out how Waters can help you have more effective approach and obtain more accurate, reproducible results during extractables and leachables studies.

Building the future of E&L testing: a story of mutual confidence between Waters and our customers

At Waters, we put our customers at the center of every decision we take. Our purpose is to build a partnership based on trust, efficence and high-quality service that we help you building tomorrow's science with today's technologies. Your success is our greatest reward. Listen to your peers testimonials about this strong Waters' engagement, and learn from them about our commitment into your success.

Megan Evans, Scientist - ECG
Learn how Waters instruments are helping her improving her sample preparation method for her E&L testing in pharmaceutical formulations and devices.

Santiago Gomez Romero,
Instrumentelle Analytik - Jänecke und Schneemann Druckfarben GmbH
Discover how Santiago is building the science of tomorrow with Waters' instruments and solving new problems in FCM & NIAS

Roberto Menzel, Laboratory Supervisor E&L - Sartorius Stedim Biotech
Find out how Waters' quality of service of our instruments are helping him getting better results for his E&L testing.

E&L past events - Watch on-demand

6-episodes Medical Devices webinar series - Sept./Oct. 2020 - Now on-demand

This webinar series provides professional expertise and technical assistance on the development, testing and regulatory compliance of medical devices. Hear about topics such as Chemical Characterization, Fatigue and Durability testing or Rheology and Thermal Characterization of Medical Devices.

>>> WATCH ON-DEMAND NOW

Identify, Characterize, Quantify

The goal in a controlled extraction study is to establish a systematic, risk-based approach packaging and device component analysis. This enables a clear understanding of structural information to determine whether the material or packaging is toxicologically acceptable for the intended purpose.

Waters addresses this need with an approach based on fast and simple differential analysis combining liquid chromatography (LC) or atmospheric pressure gas chromatography (APGC) with advanced time-of-flight (Tof) mass spectrometry (MS).

ACQUITY^® UPLC^® I-CLASS SYSTEM

The most powerful binary UPLC system, engineered for the lowest dispersion.
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ACQUITY^® APC QSM

Introducing the future of polymer characterization. Better data consistency, faster analysis and method develoment automation, discover all the assets of our brand new instrument.
Read more >>

ATMOSPHERIC PRESSURE GC (APGC)

APGC provides soft ionization, which means less fragmentation compared to techniques such as EI, resulting in higher sensitivity and specificity.
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UNISPRAY

The UniSpray™ ion source allows you to see more of your sample within a single analysis when compared to ESI, APCI or APPI.
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XEVO^® G2-XS QTOF

Identify, quantify, and confirm the broadest range of compounds in the most complex and challenging samples.
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VION

Vion takes ion mobility from research to routine, so now the benefits of ion mobility are available to every scientist, for every analysis. Read more >>

UNIFI

Waters UNIFI Scientific Information System is the first software platform to merge LC and high performance MS data (both quadrupole and time-of-flight) into a single solution that encompasses data acquisition, processing, visualization, reporting, and configurable compliance tools within a networked laboratory environment. Read more >>

Xevo TQ-XS

Whether you are analyzing small or large molecules, single analytes or multiple panels of compounds, the Xevo TQ-XS will give you the results you need, first time and without complication. Read more >>

Xevo TQ-S Micro

From the inherently robust Xevo family of tandem quadrupole instruments, the Xevo TQ-S micro provides superior performance per square inch and exceptional analytical flexibility. Read more >>

ACQUITY QDa Mass detector

Minimize the risk of unexpected coelutions or components and confirm trace components with the analytical confidence of mass detection. Enhance the analytical value and productivity of each analysis. Read more >>

EXTRACTABLES & LEACHABLES SCREENING STANDARD

Provides required information and compliance with regulatory requirement for instrument performance monitoring. Read more >>

Do you need more information about Waters solutions for Extractables & Leachables testing?

Fill in this form, and get your E&L resource kit!