Extractables and Leachables Studies (Basel, Switzerland)

Extractables and Leachables Studies for the Global Pharmaceutical Industry

We are specialized in analytical support for the pharmaceutical, food, medical device and packaging industries. With several years of hands-on experience supporting the polymer and packaging industries, we provide analytical support for:

• Extractables and leachables determination
• Impurity profiling
• Complex formulation identification

Intertek’s full-service, analytical GLP/GMP and material testing laboratories are well equipped to characterize a variety of materials and determine their critical physical and chemical properties.

We offer technical development and problem solving expertise in a number of industries including plastics, automotive, agriculture, construction & pipes, home & fabric care, inks & graphics, lubricants, packaging, paints & coatings, paper, personal care, textile & fibers and water treatment.

We can provide both routine and highly specialized services to determine and characterize extractables and leachables, including comprehensive capabilities for analytical method development and validation.

Extractables Studies for Medical Devices and Medical Packaging

• Characterization of the polymer systems
• Complete, quantitative additives and stabilizer screen
• Quick and decisive identifications of extractables including transformation or degradation products
• Determine the role of each additive in polymer formulations
• Make recommendations for alternative stabilizers for greater compatibility with the package or device to achieve lower leachability

Leachables and Migration Studies

• Conduct leachability or migration studies on polymeric medical devices or packaging
• Provide complete identification of leachables
• Formulate polymer test samples as a screening tool to evaluate potential leachables under end use conditions
• Ability to work with C14 labeled compounds
• Liquid Scintillation Counter and many other advanced analytical techniques

Extractables and Leachables Services 

• Developing and validating methods (HPLC, GC, ICP) for controlled extractables from pharmaceutical containers, closures and devices
• Identification of extractables using GC/MS and LC/MS/MS
• Modifying specific controlled extractables methods for routine E/L testing
• Validation of routine methods for product release
• Leachables profiles
• Validation of leachables methods for use in storage and stability programs
• Extractables and leachables testing for pharmaceutical packaging and compatibility 

Contact us to see how Intertek can help your organization with Extractables and Leachables Studies (Basel, Switzerland).