Highly publicized incidents and stricter regulatory controls have put a sharper focus on the analysis of extractable and leachable compounds in packaging materials and pharmaceutical products as described in USP chapters 661.1 to 661.4.
Extractable and leachable compounds can migrate from the polymeric material used in the manufacturing, storage and packaging of pharmaceuticals, biopharmaceuticals and their precursors.
The migrating compounds must not accumulate in the final products at concentrations affecting efficacy, toxicity or integrity of the product sold.
Understanding the risk, awareness of challenges and cost effective, dependable analysis is key to reducing incidents.
Agilent offer the ideal system for the analysis of extractable and leachable compounds from both liquid and solid samples.
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