Extractables & Leachables Analysis

The extraction or leaching of a sample with an aqueous buffer solution or an organic solvent is often done to analyze the safety of a material that will be implanted in a human patient or that will come into contact with pharmaceutical or food products during manufacturing or storage. Extractables testing is performed, under aggressive conditions, to identify the types of extractable chemical compounds present in the test article. Leachables analysis is typically performed under conditions that simulate use, in order to determine the amounts of undesirable chemical compounds that may enter the body or contaminate the pharmaceutical or food product.

Analysis of the sample leachate for volatile organic compounds (VOC) and semi-volatile organic compounds (SVOC) is performed using GC/MS. Analysis of the leachate for non-volatile organic compounds (NVOC) is performed using HPLC with photodiode array (PDA), evaporative light scattering (ELSD), and mass spectrometry (MS) detection. The combination of analytical techniques provides evidence of product safety.

Applications:

Biomaterials

Implants

Medical devices

Disposable products

Maxillofacial reconstruction

Tissue engineering

Drug delivery

Scaffolds

Pharmaceutical and food packaging

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Work We've Done

Extractables Analysis of Polymers Used for Medical Implants

Polymers used for implantable medical devices were tested for extractable impurities at different stages of production, including raw polymer pellets and finished devices. Gas Chromatography/Mass Spectrometry (GC/MS) with mass spectral library searching was used to identify chemical compounds extracted from the implant materials.

Concentrations of the extracted compounds were estimated via a semi-quantitative approach using internal standards. Confirmation of the library search identification and full quantitation was performed for selected chemical compounds by injection of authentic reference standards on the GC/MS.

Leachables Testing of Tubing

Several types of elastomeric tubing used in a pharmaceutical production process were screened for chemical compounds that could leach into the product during manufacturing.

The tubing samples were aged while in contact with an aqueous buffer solution. The buffer solution was then analyzed for the presence of leachable compounds using GC/MS and LC/MS.