EXTRACTABLES AND LEACHABLES FOR CONTAINER CLOSURE


Prefilled syringes (PFS) are used to deliver a wide range of pharmaceutical products. Their construction is complex with many materials involved. As each material is a potential source of leachable substances, it is important to assess the extractables/leachables profiles of the container closure system. In this case study, we describe the steps we took to identify an unexpected extractable substance during an extractables screening study of a prefilled syringe product.

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