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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 in a drug product’s immediate packaging materials, there is a regulatory requirement to assess the impact of the change. Testing is conducted to ensure that the materials are not leaching into a pharmaceutical or from a medical device to a patient. Typically, the testing is done on rubber and polymer materials or components used in medical device and pharmaceutical packaging. Analytical Testing Service providers offers a number of services for Extractables and Leachables such as: Test strategy planning and data evaluation based on the available information; Supporting of risk analysis procedures; Development of a tailored study design for extractables and leachables or chemical characterization, according pharmaceutical standards and ISO 10993 part 12/18; Extractables profiling (inorganic and organic extractables); Sequential extractions and alternative extraction techniques for isolating extractables in materials made from polymers, metals and ceramics; Characterization of extractables by chromatographic and spectroscopic investigations; Identification of a material and the identification and quantitation of the chemicals present in materials by chemical characterization; Identification and evaluation of the physico-chemical, mechanical, morphological and topographical properties of materials; Chemical and structural changes (e.g. by DSC) on polymeric materials after stressing by temperature or irradiation; Determination of the Analytical Evaluation Threshold (AET); Calculation of the AET based on Safety Concern Threshold (SCT) or Threshold of Toxicological Concern (TTC) and ICH M7 guideline; Biocompatibility: USP<87> and USP <88>; Toxicological assessments and method development and validation of potential leachables in pharmaceutical products and from medical devices; Performing leachables studies or simulated use studies on pharmaceutical products and medical devices; Reporting and evaluation of results within the current guidelines. Extractable and Leachable testing also is expanding in the extent and complexity of testing, which requires comprehensive design of the E&L program based on sound scientific principles. Trending from just detecting and quantifying the known and expected leachables has transitioned to now addressing the issues of unknown and unexpected leachables. The complexity of the E&L study program poses significant challenges for pharmaceutical product development, and requires significant expertise for the successful design and execution of an E&L program.

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    AMRI

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    Extractables & Leachables Testing Services

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    AMRI-Extractables-&-Leachables-Testing-Services

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    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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    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

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    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

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      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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            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

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            Crenza Pharma

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              Crenza is a full scale R&D centre for development of Parenteral and Ophthalmic drug products. Crenza is founded by Industry professionals with invaluable experience and proven track record of development and commercialization of Parenteral and Ophthalmic drug products for regulated markets.

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              Pharma Service: Analytical

              Category: Extractables and Leachables

              Sub Category: Testing Services

              Anacipher

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                INDIA India

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                Extractable & Leachables

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                Extractable and Leachables (both organic and inorganic) study in drug product. It offers development and validation of analytical methods, study stability sample for establishment of leachables maximum level, and qualification of extractable and leachables.

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                Pharma Service: Analytical

                Category: Extractables and Leachables

                Sub Category: Testing Services

                Boston Analytical

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                  Extractables & Leachables Analysis

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                  Boston Analytical's staff has experience evaluating Extractables & Leachables in pharmaceutical packaging, medical devices, drug-delivery/combination products, processing equipment, Single Use Systems, e-cigarettes, and consumer product packaging.

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                  Pharma Service: Analytical

                  Category: Extractables and Leachables

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                  GRAM Laboratory Inc

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                    Extractables & Leachables Study

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                    GRAM Laboratories offers development of a clinically relevant and more stable formulation. This is made possible because of the knowledge gained from preformulation evaluation. Formulation studies are customized to achieve the most appropriate formulation in a timely and cost efficient manner.

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                    Pharma Service: Analytical

                    Category: Extractables and Leachables

                    Sub Category: Testing Services

                    Aizant Drug Research Solutions Pvt. Ltd.

                    • WHO-GMP

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                    INDIA India

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                    Leachables & Extractables Studies

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                    Analytical research and development (AR&D) offers standalone services and supports our formulation development activities.

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                    Pharma Service: Analytical

                    Category: Extractables and Leachables

                    Sub Category: Testing Services

                    DPT Laboratories, Ltd

                    • FDA
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                    Extractable & Leachables

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                    DPT’s provides reliable and accurate analytical testing services for Extractable & Leachables.

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                    Pharma Service: Analytical

                    Category: Extractables and Leachables

                    Sub Category: Testing Services

                    Megsan Labs Private Limited

                    • Audit Compliance

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                    INDIA India

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                    Biofit 2020

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                    Extractable & Leachable Studies

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                    Megsan Labs is an USFDA inspected leading analytical testing laboratory, we focused and committed to deliver testing services to our costumers with excellence in quality, compliance and promptness

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                    Pharma Service: Analytical

                    Category: Extractables and Leachables

                    Sub Category: Testing Services

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