Extractables and Leachables Testing in Pharmaceuticals

Extractables and Leachables Testing helps the pharmaceutical industry identify extractables and leachables from a drugs packaging, containers or container closures   before  they pose a risk to patients.

Extractables and Leachables Testing
Extractables and Leachables Testing

Extractables extract from a container or device under controlled conditions and are used to identify potential leachables. Leachables are chemicals that come from containers or other devices and contaminate drug products during the course of its shelf-life, resulting in patient exposure. Leaching can be caused by any material that comes in direct contact with the drug at any point in the production process, and causes a change in the product’s composition. Leachable substances can cause changes to the drugs effectiveness.

Leachabless can not only be toxic, but can react with other chemicals to affect the stability of the drug. Studies and testing performed on extractables and leachables aim to reduce the harmful impurities leached from containers, packaging, or other devices and materials, that contaminate the drug product.

Some of the more susceptible devices to leaching include:

  • Inhalation Aerosols and Solutions
  • Injections and Injectable Suspensions
  • Ophthalmic Solutions and Suspensions
  • Transdermal Ointments and Patches
  • Nasal Aerosols and Sprays

When testing has identified potential leachables, a toxicologist should then review the data to determine which compounds are concerning and should be monitored. This is ultimately dependent on the toxicity at the maximum dose that a patient is likely to receive.

There are no documents provided by an approval agency that mandates protocols, every manufacturer is performing their tests different from their competitors. Each company makes different products using different devices and ingredients which ultimately means there can be no “stock” testing.

Extractables and Leachables in Pharmaceuticals
Extractables and Leachables in Pharmaceuticals

Contract Laboratory has facilitated many extractables and leachables test requests. Recent examples include:

  • Packaging laboratory needed for leachables and extractables testing in LDPE and HM-HDPE polybags
  • Medical Device manufacturer needs FDA GMP Product Safety Laboratory for Toxicology Testing to support FDA 510K application a) A comprehensive scientific justification for the use of a additive containing heavy metals in a medical device b) Extractables and Leachables Testing on the final finished device, using an exhaustive extraction at 50oC for 72 hours in both a nonpolar and polar solvent c) A dermal risk assessment for each chemical extract characterized in the solvents following the Extractables and Leachables Testing Pls comment on your proposal
  • USA Contract Lab needed to Identify and quantify unknown organic extractables and leachables released from plastic container to organic solvents using Direct injection GC/MS, Headspace GC/MS and UPLC/PDA/MS and then structural elucidation using library of extractables. OR other suitable and better method
  • India pharmaceutical analytical chemistry laboratory needed for extractables and leachables validation testing for extractable/Leachable & filter validation study
  • India toxicology laboratory needed for toxicology testing for Extractable & Leachable Study for rubber closures

And many more Extractables and Leachables Testing Studies which can be seen in Laboratory Test Requests


If your pharmaceutical company or medical research organization needs a laboratory for pharmaceutical   extractables and leachables testing in your drug products, call us at 1-855-377-6821 or submit a Laboratory Test Request.

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