USP seeks input from stakeholders on new and revised standards to mitigate extractables and leachables in plastic packaging systems. Prefilled syringes, parenteral drugs, and many therapeutic ...
The determination of elemental impurities is one of the standard tests performed as part of leachable and extractable studies for a final container-closure system (CCS). The Code of Federal ...
All laboratory plasticware contains extractables. These are the compounds in polymers and resins that, under certain conditions, might migrate into anything that contacts the plastic. Extractables can ...
Dr Bettine Boltres, Product Manager, Pharmaceutical Tubing, SCHOTT, Germany in this white paper, touches on a risk-based approach of the evaluation and describes important facts to consider when ...
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