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Extractables and Leachables From Medical Devices

Leachables are compounds that migrate from the medical device into a patient.    There are two possible routes of entry for leachables: direct patient tissue contact or by first migrating into a drug product which then carries the leachable into the patient.    Leachables present a potential risk to the patient both from the toxicity of the leachable and in the second route of entry, from impacting the stability or efficacy of the drug product.

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