Product

Extractables & Leachabales Testing for Medical Devices & Pharmaceuticals

November 6, 2020

Toxikon has developed extensive methodologies for designing studies to identify extractables and leachables in pharmaceuticals and chemical characterization for medical devices. The demand for these types of studies is increasing, as data from these assessments identifies potential contaminants that migrate from container/closure systems, tubing, and other materials, potentially rendering medical products unsafe.

These materials include, but are not limited to polymers and other plastics, elastomers, coatings, accelerants, and antioxidants. Degradation products from gamma to e-beam sterilization processes to residual solvents from manufacturing may also be present.

Toxikon uses a combination of commercially-available reference databases as well as our proprietary database, called TOXASSURE, to assist in the conduct of extractable and leachable assessments.

Analytical Techniques

• – Organic analysis by GC, GC/MS, HPLC, LC/MS, LC/MS/MS
• – Elemental analysis by ICP, GFAA and cold vapor AA
• – FTIR and UV/Vis Spectroscopy
• – pH and Total Organic Carbon (TOC) provide non-specific indications of chemical migration
• – Ion chromatography
• – Particle sizing analysis
• – Karl Fischer

Extractables & Leachables Capabilities