Informatie invloed veiligheid van migrerende stoffen in medicijnverpakkingen

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, oktober 2014).
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Migratierisico’s komen aan bod tijdens de online NVC-module Risks of pharmaceutical packaging materials.

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