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    01 Analytical Method Development

    02 Analytical Method Development

    03 Analytical Method Development

    04 Analytical Testing Services

    05 Analytical Testing Services

    06 Analytical Testing Services

    07 Extractables and Leachables

    08 Extractables and Leachables

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    01 Acceleration Laboratory Services

    02 Anacipher

    03 Analytica Chemie

    04 Aragen Life Sciences

    05 Arbro Pharmaceuticals Pvt. Ltd

    06 Arcinova

    07 Ash Stevens, Inc.

    08 BOC Sciences

    09 Boston Analytical

    10 CARBOGEN AMCIS AG

    11 CLEARSYNTH LABS LIMITED

    12 Cambrex Corporation

    13 Cayman Chemical Company Inc

    14 Curida AS

    15 Dishman Carbogen Amcis

    16 Diverchim S.A.

    17 Eurofins CDMO

    18 GRAM Laboratory Inc

    19 Globela Pharma

    20 Labiana Life Sciences S.A

    21 Megsan Labs Private Limited

    22 Nanjing Mingjie Biomedical Testing

    23 Neopharm Labs Inc

    24 Prague Scientific

    25 Primera Analytical Solutions Corp

    26 Progenerics Pharma Pvt Ltd

    27 QUINTA-ANALYTICA s.r.o

    28 Quantex Laboratories

    29 RD Laboratories

    30 Recipharm AB

    31 Renejix

    32 SEQUENT SCIENTIFIC LTD

    33 Saneca Pharmaceuticals

    34 ScinoPharm Taiwan, Ltd

    35 Seqens

    36 Servier

    37 Siegfried AG

    38 Solara Active Pharma Sciences

    39 Sushen Medicamentos Pvt. Ltd

    40 Syngene International Limited

    41 UPM Pharmaceuticals

    42 Unither Pharmaceuticals

    43 Vitas Analytical Services

    44 ZCL Chemicals Limited

    45 mKnal Global Solutions

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    01 Canada

    02 China

    03 Czech Republic

    04 Czech Republic

    05 France

    06 France

    07 India

    08 Norway

    09 Slovakia

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    Cayman Chemical Company Inc

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    CHEMICAL TESTING METHODS

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    Employing multiple chemical testing methods, we perform qualitative/quantitative analysis, purification, & characterization of chemical entities such as natural products, synthetic compounds, cosmetics, pharmaceuticals, & drugs of abuse from organic & biological matrices.

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    Pharma Service: Analytical

    Category: Analytical Method Development

    Sub Category: Impurity Isolation and Identification

    Cayman

    CPhI Japan

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    Seqens

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    Virtual BoothSeqens is an integrated global leader in pharmaceutical solutions & specialty ingredients & provides custom-made solutions.
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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 Japan

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    Prague Scientific

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    NITROSAMINE IMPURITY TESTING

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    Prague Scientific offers evaluation and method development for various nitrosamines impurities, genotoxic impurities in API, drug product and excipients.

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    Pharma Service: Analytical

    Category: Analytical Testing Services

    Sub Category: Impurity Isolation and Identification

    Nitrosamine Impurity Testing

    CPhI Japan

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    Renejix

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      IMPURITY ISOLATION & IDENTIFICATION

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      Renejix CDMO offers analytical testing services such as impurity isolation and identification, Karl Fischer and water analysis, differential scanning calorimetry (DSC), FTIR, etc.

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      Pharma Service: Analytical

      Category: Analytical Testing Services

      Sub Category: Impurity Isolation and Identification

      Impurity Isolation & Identification

      CPhI Japan

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      Renejix

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        IMPURITY ISOLATION

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        Renejix is a contract development and manufacturing organization that offers analytical method development services such as impurity isolation and identification. It also has expertise in method transfer, optimization, qualification, and validation.

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        Pharma Service: Analytical

        Category: Analytical Method Development

        Sub Category: Impurity Isolation and Identification

        Impurity Isolation

        CPhI Japan

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        Acceleration Laboratory Services

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        IMPURITIES ASSAY

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        Acceleration Laboratory Services is the foremost Contract Solutions Provider for the pharmaceutical research. The ultimate goal for our associates is to deliver superior solutions to our clients, on time, and on point, while maintaining a fun and empowering work environment.

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        Pharma Service: Analytical

        Category: Analytical Method Development

        Sub Category: Impurity Isolation and Identification
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        Arbro Pharmaceuticals Pvt. Ltd

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          IMPURITIES AND RELATED SUBSTANCES

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          Arbro offers pharmaceutical testing and research services to support the development, approval, and manufacture of pharmaceutical raw materials and finished products. Arbro is listed on a number of leading pharmaceutical manufacturer’s licenses as the contract analytical testing site.

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          Pharma Service: Analytical

          Category: Analytical Method Development

          Sub Category: Impurity Isolation and Identification
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          Primera Analytical Solutions Corp

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          DRUG SUBSTANCE IMPURITY PROFILES

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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: Analytical Method Development

          Sub Category: Impurity Isolation and Identification
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          Vitas Analytical Services

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            IMPURITY PROFILING METHODS

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            Our laboratories, equipped with the most modern instrumentation is operated by a well trained and highly motivated staff with an average of over 10 years of practical experience. The Pharmaceutical Analytical Laboratory is GMP inspected and under control of the respective authorities.

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            Pharma Service: Analytical

            Category: Analytical Method Development

            Sub Category: Impurity Isolation and Identification
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            Neopharm Labs Inc

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              IDENTIFICATION OF IMPURITIES WITH LC-MS (Q-TOF) AND GC-...

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              Our skilled and competent Chemistry group uses a wide range of methods to test raw materials, FDFs and packaging components in accordance with compendial procedures including but not limited to: USP/NF, BP, Ph. Eur, JP, CP, FCC, ACS, AOAC, AOCS, In-house and client supplied methods.

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              Pharma Service: Analytical

              Category: Analytical Method Development

              Sub Category: Impurity Isolation and Identification
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              Boston Analytical

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                ASSAY & PURITY TESTING OF PRODUCTS

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                Our testing services are performed using USP/EP guidelines in compliance with FDA and DEA guidelines. Our laboratory is continually updated with new equipment to adapt to changing regulations and the ongoing needs of our clients.

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                Pharma Service: Analytical

                Category: Analytical Method Development

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                Boston Analytical

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                  IMPURITIES / RELATED COMPOUNDS

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                  Our testing services are performed using USP/EP guidelines in compliance with FDA and DEA guidelines. Our laboratory is continually updated with new equipment to adapt to changing regulations and the ongoing needs of our clients.

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                  Pharma Service: Analytical

                  Category: Analytical Method Development

                  Sub Category: Impurity Isolation and Identification
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                  Quantex Laboratories

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                    IDENTIFICATION & QUALIFICATION OF IMPURITIES OR DEGRADA...

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                    Quantex Laboratories offers comprehensive impurities testing for both small and large molecule drug products and medical devices.

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                    Pharma Service: Analytical

                    Category: Analytical Method Development

                    Sub Category: Impurity Isolation and Identification
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                    Ash Stevens, Inc.

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                    IMPURITY ISOLATION & IDENTIFICATION (INCLUDING GTIS)

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                    Ash Stevens has a dedicated and experienced analytical department providing comprehensive support from early-stage development to commercial API manufacturing.

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                    Pharma Service: Analytical

                    Category: Analytical Method Development

                    Sub Category: Impurity Isolation and Identification
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                    mKnal Global Solutions

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                      IMPURITY SYNTHESIS, ISOLATION AND CHARACTERIZATION

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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: Analytical Method Development

                      Sub Category: Impurity Isolation and Identification
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                      Dishman Carbogen Amcis

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                      PROCESS CONTROL & MATERIAL CHARACTERIZATION

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                      Dishman strives to provides analytical services support in both process control and material characterization for laboratory and production chemistry from initial raw material release to release of the final APIs.

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                      Pharma Service: Analytical

                      Category: Analytical Method Development

                      Sub Category: Impurity Isolation and Identification
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                      GRAM Laboratory Inc

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                        QUALIFICATION OF API IMPURITY PROFILE

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                        GRAM Laboratories provides services geared towards qualification of an active pharmaceutical ingredient, through monograph testing, compendial and vendor method verification, qualification of impurity profile, independent verification of vendor’s certificate of analysis.

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                        Category: Analytical Method Development

                        Sub Category: Impurity Isolation and Identification
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                        SEQUENT SCIENTIFIC LTD

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                        IMPURITY PROFILING

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                        Sequent Research is a leading Contract Research Organization that specializes in Analytical and Bio Analytical Services to support the API, Pharmaceutical, Personal Care, Institutional and Nutraceutical companies.

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                        Category: Analytical Method Development

                        Sub Category: Impurity Isolation and Identification
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                        QUINTA-ANALYTICA s.r.o

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                        LC / MS & GC / MS METHODS FOR TRACE ANALYSIS

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                        We are skilled in the development of analytical methods for determination of trace amounts of tracked impurities. We usually develop methods for assessment of toxic impurities at levels much below those demanded by corresponding regulatory authorities.

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                        Category: Analytical Method Development

                        Sub Category: Impurity Isolation and Identification
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                        CLEARSYNTH LABS LIMITED

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                          ISOLATION & CHARACTERIZATION OF IMPURITIES

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                          Clearsynth team has extensive experience in developing, optimizing and validating methods. Our reliable analytical methods and techniques ensure that the quality of the products that we have produced is of the highest standards.

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                          Category: Analytical Method Development

                          Sub Category: Impurity Isolation and Identification
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                          Dishman Carbogen Amcis

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                          IMPURITY PROFILING & IDENTIFICATION

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                          Dishman's offers various analytical characterization services such as Structure Elucidation, Physical Characterization, Polymorphism Investigation, DSC, XPRD, FTIR studies, Particle sizing, Impurity Profiling & Identification, Formulation studies, etc

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                          Category: Analytical Testing Services

                          Sub Category: Impurity Isolation and Identification
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                          RD Laboratories

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                            IMPURITIES TESTING

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                            R.D. Laboratories maintains a large array of analytical instrumentation capable of performing a wide variety of procedures.

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                            Pharma Service: Analytical

                            Category: Analytical Method Development

                            Sub Category: Impurity Isolation and Identification
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                            QUINTA-ANALYTICA s.r.o

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                            ISOLATION OF SELECTED COMPONENTS

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                            We use either a classical low-pressure column chromatography or HPLC on our automated semi-preparative modular HPLC system (Waters).

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                            Pharma Service: Analytical

                            Category: Analytical Method Development

                            Sub Category: Impurity Isolation and Identification
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                            ZCL Chemicals Limited

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                            IMPURITY PROFILE STUDIES

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                            Our highly qualified professionals are working in product development, analytical development & IP rights. Our activities include Route Scouting, Process Development, Scale up, Technology Transfer, Synthesizing Impurities, Contract Research etc

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                            Pharma Service: Analytical

                            Category: Analytical Method Development

                            Sub Category: Impurity Isolation and Identification
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                            Solara Active Pharma Sciences

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                            IMPURITY PROFILING

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                            Solara's R&D capabilities in synthetic development services, and analytical development services offers impurity profiling and quantification at trace levels (genotoxic impurities in PPB and PPM) using LCMS-MS & GCMS-MS.

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                            Category: Analytical Method Development

                            Sub Category: Impurity Isolation and Identification
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                            Anacipher

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                              IMPURITIES STUDY

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                              Impurities of Drug products, API and intermediates can be studied. Impurities and degradation of products can be studied and unknown impurities can be identified by means of LC-MS and LC-MS-MS analysis. Specified impurity contained within the sample can be isolated, purified and identified.

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                              Category: Analytical Method Development

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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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                              Category: Extractables and Leachables

                              Sub Category: Impurity Isolation and Identification
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                              Sushen Medicamentos Pvt. Ltd

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                                SEPARATION & PURIFICATION OF IMPURITIES

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                                SUSHEN Medicamentos (SUSHEN), is a global company of end-to-end pharmaceutical services with focus on drug delivery research and product development. SUSHEN’s expertise can bring a complex formulation project in to clinical and bioequivalence with superior quality, innovative solution.

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                                Category: Analytical Method Development

                                Sub Category: Impurity Isolation and Identification
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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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                                Arbro Pharmaceuticals Pvt. Ltd

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                                  IMPURITY PROFILING METHODS

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                                  The team at Arbro undertakes the development of analytical methods using HPLC, GC, AAS, HPTLC, ICP-MS, GCMS, LCMSMS, chemical and microbiological and many other techniques. All methods developed by our lab are fully validated as per the current requirements laid down in the ICH guidelines Q2(R1).

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                                  Category: Analytical Method Development

                                  Sub Category: Impurity Isolation and Identification
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                                  Curida AS

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                                    IDENTIFICATION OF ACTIVE INGREDIENTS & IMPURITIES

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                                    Curida Laboratories have more than 40 years of experience within the pharmaceutical industry. We offer a wide range of quality control testing services to support development of methods, routine testing of raw materials and finished products as well as stability testing.

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                                    Category: Analytical Method Development

                                    Sub Category: Impurity Isolation and Identification
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                                    ScinoPharm Taiwan, Ltd

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                                    IDENTIFICATION OF IMPURITIES

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                                    ScinoPharm's comprehensive analytical services include purity testing, characterization of polymorphs, analytic methods development & validation, & stability testing. All analytical instruments & data are managed through the company's LIMS.

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                                    Pharma Service: Analytical

                                    Category: Analytical Method Development

                                    Sub Category: Impurity Isolation and Identification
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                                    Progenerics Pharma Pvt Ltd

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                                      IMPURITIES

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                                      We provide full range of analytical services, State-of-the-art instruments, cutting-edge technologies, and experienced scientific staff ensure efficient, high-quality and cost-effective services.

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                                      Pharma Service: Analytical

                                      Category: Analytical Method Development

                                      Sub Category: Impurity Isolation and Identification
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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

                                      Sub Category: Impurity Isolation and Identification
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                                      Eurofins CDMO

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                                      IMPURITIES ISOLATION & IDENTIFICATION

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                                      Eurofins CDMO offers a complete CMC gap analysis & risk assessment including fate & purge studies & impurities markers synthesis. They offer chromatography for the isolation of process impurities, LC/MS-MS/MS and multi-nuclear NMR for characterization.

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                                      Pharma Service: Analytical

                                      Category: Analytical Method Development

                                      Sub Category: Impurity Isolation and Identification
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                                      Syngene International Limited

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                                      IMPURITY ISOLATION AND IDENTIFICATION

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                                      Syngene supports multiple approaches such as analytical method development combined with in-house validation. Additionally, they offer expertise in impurity isolation, microbiology testing, semi-preparatory and preparatory purification.

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                                      Pharma Service: Analytical

                                      Category: Analytical Testing Services

                                      Sub Category: Impurity Isolation and Identification
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                                      Nanjing Mingjie Biomedical Testing

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                                        NITROSAMINE IMPURITY DETECTION SERVICES

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                                        Mingjie Pharmaceuticals has dozens of nitrosamine reference substance reserves, and has a variety of high-sensitivity analysis methods. It provides nitrosamine risk assessment report, nitrosamine impurity method development, verification & sample testing.

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                                        Pharma Service: Analytical

                                        Category: Analytical Testing Services

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                                        Analytica Chemie

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                                          IMPURITY ISOLATION AND IDENTIFICATION

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                                          Analytica Chemie has GMP & GLP compliant, state-of-the art analytical chemistry services laboratory offering isolation and characterisation of unknown impurities (even at trace levels), metabolites and degradation products from APIs and finished products.

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                                          BOC Sciences

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                                            IMPURITY ISOLATION AND IDENTIFICATION

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                                            BOC Sciences' pharmaceutical separation and purification team are committed to the separation and identification of various impurities in the process of pharmaceutical research. It provides comprehensive impurity isolation and identification services.

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                                            Category: Analytical Testing Services

                                            Sub Category: Impurity Isolation and Identification
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                                            Labiana Life Sciences S.A

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                                            CHARACTERIZATION OF THE IMPURITY PROFILE

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                                            In the analytical development area, LABIANA GROUP offers a wide range of services for pharmaceutical and veterinary industries and provides study of solubility in different media.

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                                            Category: Analytical Method Development

                                            Sub Category: Impurity Isolation and Identification
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                                            Megsan Labs Private Limited

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                                            IMPURITY PROFILING

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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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                                            Category: Analytical Method Development

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                                            Megsan Labs Private Limited

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                                            RESIDUAL GENOTOXIC IMPURITIES TESTING

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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: Analytical Method Development

                                            Sub Category: Impurity Isolation and Identification
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                                            UPM Pharmaceuticals

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                                            PURITY TESTING

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                                            UPM’s analytical group has a diverse background in analytical method development and in-depth understanding of all facets of the drug development process.

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                                            Pharma Service: Analytical

                                            Category: Analytical Method Development

                                            Sub Category: Impurity Isolation and Identification
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                                            Arcinova

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                                              IMPURITY ISOLATION AND IDENTIFICATION

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                                              We perform impurity & degradation product identification through mutagenicity assessments. Our flexible approach allows us to provide this service both on a stand-alone basis or as part of an integrated service.

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                                              Pharma Service: Analytical

                                              Category: Analytical Testing Services

                                              Sub Category: Impurity Isolation and Identification
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                                              Servier

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                                              IMPURITY TRACKING & CHARACTERIZATION

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                                              Servier CDMO offers a full range of contract development and manufacturing services, from concept and product development to analytical testing, commercial scale and regulatory approval.

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                                              Pharma Service: Analytical

                                              Category: Analytical Method Development

                                              Sub Category: Impurity Isolation and Identification
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                                              Cambrex Corporation

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                                              IMPURITY ISOLATION AND IDENTIFICATION

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                                              At Cambrex we have a proven track record of identifying, isolating and characterizing impurities. Areas of expertise and capabilities include mass spectrometry (MS), preparative and semi-preparative chromatography, and NMR spectroscopy.

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                                              Pharma Service: Analytical

                                              Category: Analytical Method Development

                                              Sub Category: Impurity Isolation and Identification
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                                              Servier

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                                              IDENTIFICATION OF PHARMACEUTICAL IMPURITIES

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                                              Servier brings 60 years of experience in process development, intermediates, APIs and high-potency APIs. Our full cGMP?/?FDA-approved chemistry network includes R&D, production and supply chain expertise with full regulatory support.

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                                              Pharma Service: Analytical

                                              Category: Analytical Method Development

                                              Sub Category: Impurity Isolation and Identification
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                                              Diverchim S.A.

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                                              PURIFY & CHARACTERIZE PROCESS IMPURITIES

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                                              Thanks to its innovative techniques (HPLC, SFC or combined preparative HPLC/SFC), DIVERCHIM proposes to its customers to isolate, purify and characterize process impurities as well as reference compounds.

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                                              Pharma Service: Analytical

                                              Category: Analytical Method Development

                                              Sub Category: Impurity Isolation and Identification
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                                              CARBOGEN AMCIS AG

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                                              IMPURITY PROFILING & IDENTIFICATION

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                                              Carbogen Amcis SAS state-of-the-art infrastructure includes process research and development (PR&D) laboratories, one laboratory dedicated to conjugation of small and large molecules and manufacturing capabilities.

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                                              Pharma Service: Analytical

                                              Category: Analytical Method Development

                                              Sub Category: Impurity Isolation and Identification
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                                              CARBOGEN AMCIS AG

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                                              GEL PERMEATION CHROMATOGRAPHY FOR IMPURITIES

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                                              CARBOGEN AMCIS state-of-the-art infrastructure includes process research and development (PR&D) laboratories, one laboratory dedicated to conjugation of small and large molecules and manufacturing capabilities.

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                                              Pharma Service: Analytical

                                              Category: Analytical Method Development

                                              Sub Category: Impurity Isolation and Identification
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                                              Globela Pharma

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                                              IMPURITY PROFILING & IDENTIFICATION

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                                              Globela Pharma Pvt Ltd has uplifted our existing R & D facility, and installed fully functioning in house R & D center- with state of the art infrastructure, and experienced, skilled manpower.

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                                              Pharma Service: Analytical

                                              Category: Analytical Method Development

                                              Sub Category: Impurity Isolation and Identification
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                                              Siegfried AG

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                                              PURITY PROFILES & IMPURITY TRACKING

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                                              Siegfried recognizes and understands the importance of requisite analytical parameters & controls, as they are vital for ensuring effective and robust processes.

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                                              Pharma Service: Analytical

                                              Category: Analytical Method Development

                                              Sub Category: Impurity Isolation and Identification
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                                              Aragen Life Sciences

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                                              ISOLATION OF IMPURITIES & PURIFICATION OF COMPOUNDS

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                                              GVK BIO offers a broad range of analytical services for complex research needs. GVK BIO has expertise in isolation of impurities & purification of compounds using preparative LC & SFC.

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                                              Pharma Service: Analytical

                                              Category: Analytical Method Development

                                              Sub Category: Impurity Isolation and Identification
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                                              Siegfried AG

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                                              GENOTOXIC CONTAMINATION

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                                              Siegfried recognizes and understands the importance of requisite analytical parameters & controls, as they are vital for ensuring effective and robust processes.

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                                              Pharma Service: Analytical

                                              Category: Analytical Method Development

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                                              Aragen Life Sciences

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                                              IMPURITY & DEGRADATION PRODUCT IDENTIFICATION

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                                              GVK BIO offers a broad range of analytical services for complex research needs. We perform method development, validate and transfer Good Manufacturing Practice (cGMP) compliant methods for a broad spectrum of pharma compounds.

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                                              Aragen Life Sciences

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                                              IMPURITY & DEGRADATION PRODUCT STRUCTURAL ELUCIDATION

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                                              GVK BIO offers a broad range of analytical services for complex research needs. We perform method development, validate and transfer Good Manufacturing Practice (cGMP) compliant methods for a broad spectrum of pharma compounds.

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                                              Pharma Service: Analytical

                                              Category: Analytical Method Development

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                                              Aragen Life Sciences

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                                              RELATED IMPURITIES

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                                              GVK BIO offers a broad range of analytical services for complex research needs. We perform method development, validate and transfer Good Manufacturing Practice (cGMP) compliant methods for a broad spectrum of pharma compounds.

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                                              Category: Analytical Method Development

                                              Sub Category: Impurity Isolation and Identification
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