ARDL offers comprehensive support for extractables and leachables studies, with years of experience in identifying and quantifying organic and inorganic components in a wide variety of products, including: polymers, plastics, metals, pharmaceuticals and other matrices.
Extractables are chemical species that migrate from a product or packaging component under aggressive exposure or storage conditions such as high temperature, long duration or contact with solvents.
Leachables are chemical species that migrate from a product or packaging component under normal conditions of exposure or storage.
Techniques
Analytical techniques involved in extractables and leachables studies include:
• Gravimetric and Colormetric Analysis
• Inorganic Species by ICP-OES and Cold Vapor AA
• Organic Species by GC, GC/MS, HPLC, LC/MS
• pH
• Spectroscopy (UV/VIS, FTIR)
• Total Organic Carbon (TOC)
Good Manufacturing Practices
21CFR211.94(a)(b)
