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Leachables from plastic materials in contact with drugs.

    https://www.sciencedirect.com/science/article/pii/S0378517320303161
    Plastic material refers to a material that contains one or more organic macromolecular compounds obtained by polymerisation, polycondensation or …

Leachables from plastic materials in contact with drugs.

    https://pubmed.ncbi.nlm.nih.gov/32360549/
    Abstract. The plastics used in drug packaging systems and medical devices are composed of homologous polymers and generally contain additives such as …

Extractable/Leachable Substances from Plastic Materials …

    https://journal.pda.org/content/56/6/332
    The review considers both the identification of such leachables as well as their reported levels in actual and simulated pharmaceutical products. A review is provided …

Making plastics safe for medical devices

    https://www.medicalplasticsnews.com/medical-plastics-industry-insights/play-it-safe/
    Extractables & Leachables Plastic materials used in medical devices and pharmaceutical packaging play a vital role in delivery of safe treatments. However, they …

Extractables and Leachables Information

    https://www.thermofisher.com/us/en/home/industrial/pharma-biopharma/pharma-biopharma-learning-center/pharmaceutical-qa-qc-information/extractables-leachables-information.html
    Extractable and leachable impurities from pharmaceutical container-closure and production systems. In May 1999, the U.S. FDA published a guidance document on Container …

Do extractables and leachables affect

    https://www.medicalplasticsnews.com/news/how-do-extractables-and-leachables-impact-combination-produc/
    Leachables are defined as organic and inorganic chemical entities that are present in a packaged drug product because they have migrated into the …

ISO 10993-18 Medical Device Chemical Characterization …

    https://www.intertek.com/medical/iso10993part18-medical-device-chemical-characterisation-extractables/
    The data from chemical characterisation studies can inform the toxicological risk analysis in order to demonstrate biological safety. The European Medical Device Regulation (EU …

Extractables and leachables Medical Plastics News

    https://www.medicalplasticsnews.com/topics/extractables_and_leachables/
    22 Jun 2020 Sandi Schaible Medical Plastics News + Manufacturer completes extractables testing for silicone tubing Freudenberg Medical, a global contract …

Medical Device Extractables and Leachables Testing

    https://www.campoly.com/cpg-services/analytical-testing/extractablesleachables/medical-device-extractables-and-leachables-testing/
    Leachables are compounds that migrate from a product into a surrounding media under simulated end-use conditions more closely aligned to the physiological environment. For …

Analyzing Leachables from Plastics | Lab Manager

    https://www.labmanager.com/insights/analyzing-leachables-from-plastics-3009
    Analyzing potential leachables in plastic packaging usually requires an extraction technique and then mass spectrometric (MS) detection. There are millions of …



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