Safety impact information for extractables in pharmaceutical packaging
Leachables from packaging systems can accumulate in drug products and potentially affect the drug product. Although drug products can be analyzed for leachables, not all leachables or extractables can be fully identified. Safety thresholds can be used to establish whether the unidentified substances can be deemed to be safe.
This article contains safety data for over 500 extractables that were identified in laboratory characterizations of polymers used in pharmaceutical applications. The safety data consists of structural toxicity classifications of the extractables as well as calculated risk indices (PDA Journal of Pharmaceutical Science and Technology, October 2014).
Click here for an abstract of the article.
Migration/exchange risks are covered in the online NVC module Risks of pharmaceutical packaging materials.
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