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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

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    Extractables & Leachables Testing Services

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    AMRI-Extractables-&-Leachables-Testing-Services

    - Service Details

    AMRI offers extractables and leachables (E&L) testing services to assist in the evaluation of the manufacturing process, including single use systems (SUS), final container/closure, drug delivery devices & overall packaging configuration of your product.

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    Pharma Service: Analytical

    Category: Extractables and Leachables

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    West pharma services

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    BIO Digital 2021

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    Extractables & Leachables Testing For Deliver...

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    West offers extractables/leachables analysis for packaging and delivery systems for all pharmaceutical and biological products.

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    Pharma Service: Analytical

    Category: Extractables and Leachables

    Sub Category: Testing Services

    Primera Analytical Solutions Corp

    • FDA

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    Assessment of Leachables & Extractables In Dr...

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    Primera specializes in customized analytical method development, transfer and validation using state-of-the-art analytical tools. We also provide cGMP Sample Storage and testing services. With no observations and no 483 findings from two FDA audits, We are in full compliance with GLP/cGMP regulations.

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    Pharma Service: Analytical

    Category: Extractables and Leachables

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    mKnal Global Solutions

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      INDIA India

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      Extractable & Leachable Studies

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      Our integrated product development services help biopharmaceutical companies shorten time to market, manage risk and access new global markets to maximize portfolio value.

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      Pharma Service: Analytical

      Category: Extractables and Leachables

      Sub Category: Testing Services

      Pace Analytical Services, LLC

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        Extractable & Leachable Testing

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        With a nationwide network of 29 environmental laboratories, 3 life sciences labs, 2 LabOps locations, and 46 service centers, Pace Analytical offers compendia (USP, EP, JP) methods of analytical services for qualitative and quantitative assessment of raw materials, APIs and Finished Products.

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        Pharma Service: Analytical

        Category: Extractables and Leachables

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        Quantex Laboratories

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          Assessment of Leachables & Extractables In Dr...

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          Our scientists conduct extractables and leachables studies in accordance with Good Manufacturing Practices (GMPs) ,PQRI recommendations, United States Pharmacopeia (USP) requirements.

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          Pharma Service: Analytical

          Category: Extractables and Leachables

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          Vitas Analytical Services

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            NORWAY Norway

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            BIO Digital 2021

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            Assessment of Leachables & Extractables In Dr...

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            Our extractables and leachables analytical services include: Modify and validate controlled extractable methods for testing and profiling of leachables and Develop HPLC, GC, and MS methods for controlled extractables from pharmaceutical containers, closures and devices.

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            Pharma Service: Analytical

            Category: Extractables and Leachables

            Sub Category: Testing Services

            Crenza Pharma

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