Extractables and Leachables

Toxikon has developed extensive methodologies for designing studies to identify extractables and leachables in medical devices and pharmaceutical products. The demand for these types of studies by U.S. and other governing bodies is increasing, as data from these assessments identifies potential contaminants that migrate from containers, closure systems, tubing, and other materials, potentially rendering drug 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's Extractables and Leacheables testing capabilities include evaluations for:

• Inhalants/MDI
• Parenterals/Injectibles
• Drug Delivery Systems
• Implants
• Primary/Secondary
• Container Closure Systems
• Raw Material/Polymers
• Material Comparison
• Residual Analysis

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Extractables and Leachables Testing for Medical Devices | Medical Device Contract Manufacturing | Medical Device / Product Biocompatibility Testing Services
Extractables and Leachables Testing for Medical Devices and Container Closure Systems Medical Device Biocompatibility, Medical Device Contract Manufacturing, Medical Device Development, Medical Device Manufacturing, Medical Device Product Development, Medical Device Testing, Medical Device Testing Services, Medical Product Development Inhalants/MDI Parenterals/Injectibles Drug Delivery Systems Implants Primary/Secondary Container Closure Systems Raw Material/Polymers Material Comparison Residual Analysis Analytical Methods Organic analysis via GC, GC/MS, HPLC, HPLC/ELSD, LC/MS Ion chromatography Elemental analysis by ICP, CVAA, and ICP-MS FTIR and UV/VIS Spectroscopy pH, Conductivity, Total Organic/ Inorganic Carbon Particle sizing analysis Karl Fischer Chemistry Support Test article characterization ICH stability testing Routine formulation analysis Method Development/Transfer/Validation ISO 10993, parts 9, 13, 14, 15, and 18 protocol and support services Raw and finished product testing Physicochemical studies (European Pharmacopoeia, USP and JP) Accelerated aging, forced degradation, and photostability Manufacturing residual analysis Sterilization residual analysis (EO, EC, and EG) USP compendia studies Plasticizers Analysis (Partial Listing) bis(2-ethylhexyl) phthalate (DEHP) bisphenol A (BPA) Tris (2-Ethylhexyl) Trimellitate (TOTM) Di-isobutyl phthalate Di-n-butyl phthalate Di-n-octyl phthalate Dinonyl phthalate Antioxidant Analysis (Partial Listing) Butylhydroxytoluene (BHT) Irganox 1010, Irganox 1076 Irgafos 168
Toxikon is a well-known global contract research company partnering with biotech, pharma and medical device researchers in clinical trials, research and development programs, and product development. For more company information, visit our website!