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    Looking for Extractables and Leachables? Find Analytical & other pharma service details on PharmaCompass.

    HTL Biotechnology is the world leader in the responsible development and production of pharmaceutical-grade biopolymers.
    Polpharma is a Polish CDMO of APIs and a significant European API producer, delivering products to companies worldwide.
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    01 Chemical Characterization (2)

    02 Impurities (1)

    03 Impurity Isolation and Identification (4)

    04 Testing Services (16)

    05 Toxicological Risk Assessment (TRA) (1)

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    01 Seqens (1)

    02 Aizant Drug Research Solutions Pvt. Ltd. (1)

    03 Anacipher (2)

    04 Boston Analytical (1)

    05 Cambrex Corporation (1)

    06 Crenza Pharma (1)

    07 Curida AS (1)

    08 DPT Laboratories, Ltd (2)

    09 Doctor's Analytical Laboratories (1)

    10 GRAM Laboratory Inc (1)

    11 Megsan Labs Private Limited (1)

    12 Pace Analytical Services, LLC (1)

    13 Primera Analytical Solutions Corp (1)

    14 Quantex Laboratories (1)

    15 Recipharm AB (1)

    16 Saneca Pharmaceuticals (1)

    17 Sartorius Stedim Biotech (1)

    18 Solvias (1)

    19 Unither Pharmaceuticals (1)

    20 Vitas Analytical Services (1)

    21 West pharma services (1)

    22 mKnal Global Solutions (1)

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    01 France (2)

    02 Germany (1)

    03 India (7)

    04 Norway (2)

    05 Slovakia (1)

    06 Sweden (1)

    07 Switzerland (1)

    08 U.S.A (9)

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    Seqens

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    IMPURITY IDENTIFICATION

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    Seqens has broad expertise in impurity identification to perform extractable and leachable testing, supported by best-in-class analytical technologies. It has well established methodologies to analyze extraction solutions by LC/MS, GC/MS, and ICP-MS.

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    Pharma Service: Analytical

    Category: Extractables and Leachables

    Sub Category: Impurity Isolation and Identification

    Impurity Identification

    CPhI North America

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    West pharma services

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    EXTRACTABLES & LEACHABLES TESTING FOR DELIVERY SYSTEMS

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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

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    Primera Analytical Solutions Corp

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    ASSESSMENT OF LEACHABLES & EXTRACTABLES IN DRUG PRODUCT...

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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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    mKnal Global Solutions

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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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      Quantex Laboratories

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        ASSESSMENT OF LEACHABLES & EXTRACTABLES IN DRUG PRODUCT...

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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

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        Vitas Analytical Services

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          ASSESSMENT OF LEACHABLES & EXTRACTABLES IN DRUG PRODUCT...

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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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            EXTRACTABLE & LEACHABLE STUDY

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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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            Unither Pharmaceuticals

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            EXTRACTABLES & LEACHABLES ANALYSIS

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            Unither analytical services include method development & validation, analytical method transfer & ICH stability studies. They provide extractable & leachable closure system compatibility studies, unknown substance identification & characterization etc.

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            Pharma Service: Analytical

            Category: Extractables and Leachables

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            Anacipher

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              GENOTOXIC EVALUATION

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              Genotoxicity of the impurity can be evaluated based on FDA approved software. It offers genotoxic and Potential extractable and leachables studies and stablishment of Specification and acceptance criteria

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              Pharma Service: Analytical

              Category: Extractables and Leachables

              Sub Category: Toxicological Risk Assessment (TRA)
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              Anacipher

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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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                Saneca Pharmaceuticals

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                SYNTHESISING & CHARACTERISING IMPURITIES

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                At Saneca Pharma, we offer a range of generic API development services including route of synthesis optimisation. Our API development & manufacturing facilities use the same equipment to take your project from pilot to commercial scale production.

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                Pharma Service: Analytical

                Category: Extractables and Leachables

                Sub Category: Impurity Isolation and Identification
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                Curida AS

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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
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                  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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                    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

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                      Recipharm AB

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                      IMPURITY IDENTIFICATION

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                      Recipharm has extensive experience and a range of analytical and synthetic equipment to conduct successful impurity identification in pharmaceutical products.

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                      Pharma Service: Analytical

                      Category: Extractables and Leachables

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                      Aizant Drug Research Solutions Pvt. Ltd.

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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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                      Solvias

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                      EXTRACTABLE & LEACHABLE TESTING SERVICES

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                      Solvias provides expert testing and consulting services to assess the safety and integrity of extractables and leachables in pharmaceuticals by providing customizable workflow for quantitative extractables studies.

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                      DPT Laboratories, Ltd

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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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                      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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                        Megsan Labs Private Limited

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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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                        Sartorius Stedim Biotech

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                          EXTRACTABLES & LEACHABLES TESTING SERVICES

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                          Sartorius offers unique expertise in the field of extractables & leachables, such as extractables evaluation, extractables & safety assessments, E&L long-term/storage studies for different container materials, leachables screening, etc.

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                          Doctor's Analytical Laboratories

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                            EXTRACTABLE & LEACHABLES TESTING SERVICES

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                            DALPL's current services at the pharma division include extractable & leachables as per FDA guidelines & PQRI suggestions, genotoxic impurity [nitrosamine impurities] quantification studies, carryover impurity studies, elemental impurities by ICP MS, etc.

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                            Cambrex Corporation

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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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                            DPT Laboratories, Ltd

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                            IMPURITIES TESTING

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                            DPT’s provides reliable and accurate analytical testing services for Impurities.

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