Controlled extractables and leachables (E/L) studies are applied to a wide variety of compounds and materials, including both organic and inorganic elements. Products can include container closure systems (CCS), drug delivery systems such as pre-filled syringes and vials, orally inhaled and nasal drug products (OINDP), single use and disposable medical equipment, pharmaceutical packaging through to cell culture and bioprocessing systems. Extractables and leachables studies can provide both qualitative and quantitative data to build a comprehensive profile of extractable components and determine the extent to which such components actually leach and potentially contaminate a drug substance or drug product. Intertek offers these services through two cGMP-compliant laboratories located in Manchester, UK and Whitehouse, NJ.
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