Safety risk categorization of organic extractables associated with polymers used in packaging for parenteral drug products

Purpose of this research was to develop and justify a Risk Evaluation Matrix for estimating the safety risk associated with extractables from plastic materials used in pharmaceutical applications. Purpose was to apply that matrix to extractables to assess the risk that they would accumulate in drug products at levels sufficiently high to affect patient safety.
Approximately 15% of the extractables were categorized as lowest risk and 3% of the extractables as highest risk. Categorization of extractables could facilitate the selection of materials for use in pharmaceutical systems, the analytical testing of extracts and the selection of target extractables (Pharmaceutical Research, 4 October 2014).
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