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    The examination of extractable and leachable substances (such as plasticizers, antioxidants, stabilizers and dyes) is extremely important for the protection of patients and for regulatory documentation destined for authorities such as the FDA and EMA. In recent years, the pharmaceutical industry has developed a better understanding of the impact of extractables and leachables on patient safety and drug product interaction, leading to increased scrutiny by the regulators. When there is a change

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    AMRI

    Cambrex Corporation

    Curida AS

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    NORWAY

    UNITED STATES

    AMRI

    • FDA
    • EDQM
    • WHO-GMP

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    CPhI Japan 2021

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    Chemical Characterization

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    AMRI-Chemical-Characterization

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    AMRI's experts work directly with regulators to participate in standard setting activities for ISO 10993-18 & ISO 10993-17

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    Pharma Service: Analytical

    Category: Extractables and Leachables

    Sub Category: Chemical Characterization

    Curida AS

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      NORWAY Norway

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      USP Workshop 2021

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      Physical & Physio-Chemical Determinations

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      Physical and physio-chemical determinations (e.g. pH,nconductivity, viscosity, melting point, refractometer, polarimeter, sub-visible particle counter, osmolality, loss on drying)

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      Pharma Service: Analytical

      Category: Extractables and Leachables

      Sub Category: Chemical Characterization

      Cambrex Corporation

      • FDA
      • EDQM

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      UNITED STATES United States

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      USP Workshop 2021

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      Chemical Characterization

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      We offer Integrating Capabilities of Building product safety into process design under one roof, which can facilitate a smooth product launch by ensuring minimal impact from impurities, all while mitgating risks associated with the final product.

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      Pharma Service: Analytical

      Category: Extractables and Leachables

      Sub Category: Chemical Characterization

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