Standardization of Chromatographic Screening Methods for Organic Extractables and Leachables by Managing Outcomes.
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DOI: 10.5731/pdajpst.2021.012671
Abstract: Drug products and medical devices can contain impurities, termed leachables, which could produce an adverse patient health effect during clinical use. To establish patient exposure to leachables, drug products, packaging or manufacturing system extracts are… read more here.
Keywords: standardization; screening methods; risk assessment; organic extractables ... See more keywords