Extractables and Leachables Analysis
Extractables and Leachables testing and analysis to support pharmaceutical and medical devices.
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 provide 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 extractable and leachable testing services through cGMP-compliant laboratories located in Whitehouse, NJ (USA), Manchester (UK), and Basel, Switzerland. India also offers non-GMP Extractables studies.
Extractable and Leachable Services:
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