eBook: Good Identification Practices for Organic Extractables and Leachables Via Mass Spectrometry

An important class of drug product or medical device impurities is leachables. Leachables are foreign impurities that are present in a drug product because of its chemical interaction (leaching) with its packaging and/or manufacturing systems. When patients are dosed with the drug product, they are exposed to the drug product’s impurities, including leachables.

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eBook: Good Identification Practices for Organic Extractables and Leachables Via Mass Spectrometry

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