Extractables and Leachables (E&L) studies in compliance with GLP

E&L studies in accordance with international guidelines and requirements

    • Capabilities to identify and quantify unknown organic and inorganic impurities
    • Facilities to analyze volatile organics, semi-volatile organics, non-volatile organics, inorganics and metals
    • E&L studies for medical devices and their materials
    • Chemistry expertise in understanding and predicting the likely contaminants and their source
    • Expertise in understanding the extractables and their degradation products
    • Designing procedures for extraction studies specific to the product and the packaging
    • Accelerated extraction procedures for extractables
    • Long term studies for leachables and secondary leachables
    • Availability of toxicological expertise to assess the toxic nature of the migrating impurities
    • Equipment like, LC-MS/MS, GC-MS/MS, ICP-MS, IC, NMR, FTIR, Headspace GC-FID/MS, etc.