Quality testing and chemical analysis services helping scientific, technology and manufacturing companies compete in the global market.

Call us at: 1-800-930-5450

Extractable and Leachable Testing

Method Development/Validation Quality Control Chemical Characterization
Extractables/Leachables Testing
Deformulation Stability/Release Testing

Leachable Testing

Extractable and leachable testing studies the organic and inorganic compounds that may be released from packaging material, or absorbed into a product from plastic additives, or low molecular weight components in the plastic.   Avomeen’s chemists are trained to identify and quantitate the extractables and leachables, validate the analytical methods, and then work with your team to determine the safety implications and suggest alternative packaging if necessary.

This type of testing is critical for the pharmaceutical and medical devices industries, where packaging safety and toxicology studies are required for product registration.

Avomeen will work with clients to develop a customized testing protocol to meet your regulatory requirements, whether your need is for a package or medical device registration, a label migration study, packaging for food contact, or simply consumer product testing for unknown contaminates, Bisphenol A (BPA), and Phthalates (Such as DEPH).

Extractable Testing:

  • Separate components using Avomeen’s proprietary extractions protocol
  • Analyze extracts using HPLC, GC-MS, FT-IR, ICP, IC, etc.
  • Identify unknowns – validate the analytical method

Leachable Testing:

  • Identify and quantify all compounds that do not originate from the target product
    • If contaminated samples are not available, we can recreate appropriate ICH stability testing conditions to generate the leachables.
  • Compare compounds to those identified in extractables phase of the study
Case StudyProduct Contamination

Industry: Packaging Manufacturer
Problem: Choosing right vendor for plastic bottles
Solution: A baby food manufacturer wanted to switch from glass jars to plastic bottles to market its baby food product. The client was most concerned about safety concerns, as plastics are known to leach chemicals such as plasticizers and other additives. The manufacturer had identified three vendors that supplied plastic bottles. The challenge was to identify the plastic bottles that would release the least amount of chemicals. Our scientists performed a leachable and extractable testing study by exposing the plastic bottle to temperatures and foods similar to real life conditions. The leached chemicals were then identified and quantified at parts per million level, using techniques such as LC/MS and GC/MS. The study identified the supplier with the safest plastics packaging.


For More Information Or A Free Quote, Please Request A Extractable and Leachable Testing Quote Or Call (800) 930-5450 Today.



Problem Solving
Avomeen scientists utilize the latest techniques, instrumentation, and methods to analyze a wide variety of complex testing challenges.
Customer Service
Our whole team is committed to completing each customer's project to their exact specifications, including custom methods and rush services.
Instrumentation
Avomeen's investigations include the use of FT-IR, GC/MS, LC/MS, HPLC, NMR, SEM/EDXA, ICP, AA, TGA, DSC, and many other techniques.
Contact Us
Avomeen Analytical Services
6107 Jackson Road
Ann Arbor, MI 48103
Phone: 1-800-930-5450
Fax: 1-800-930-5479
Email: info@avomeen.com