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    Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced. Many factors are attributed to this rapid market growth, including continuous outsourcing from pharmaceutical companies, growing pipelines for biological candidates, and increasing demand for more analytical details on drugs and process development by regulatory agencies. In response to the changing market dynamics, service providers are striving to provide analytical testing with quality, accuracy, and robustness all within tight timelines. As the contract research organizations (CROs) have become more integrated, small analytical labs need to establish their niche to succeed. Global contract analytical Laboratories provide QC laboratory analysis, method development, validation and expert advice for both finished products and raw materials for pharmaceutical and biopharmaceutical companies. Stability assay methods should be specific enough to differentiate between analytes and possible degradation products. The overall quality of drug-substance and drug-product batches placed on formal stability studies should represent the quality of materials used in clinical studies and of the quality of materials to be made at manufacturing scale. Supporting stability data can be provided using stability data generated from batches of drug substances and drug products made on a laboratory scale. Stability studies also should be conducted on material stored in a container–closure system that is the same as (or simulates) packaging proposed for real storage and distribution. Stability Studies are performed to understand the compounds/formulation in development: Physical & Chemical properties of API and drug product, Drug and excipient compatibility, Impact of manufacturing process steps, Interactions with packaging materials, Assignment of shelf life etc. Analytical stability programs for a drug substance or drug product also can be used for the characterization of impurities and related substances in line with dissolution studies, and to residual solvents, disintegration, and friability. Testing can be performed at ambient temperature, accelerated conditions, intermediate conditions, and other storage conditions. cGMP stability analyses include ICH Stability Services, Real-Time & Long Term Stability, Accelerated Stability, Forced Degradation Studies, Stress Stability Testing, R&D Stability Testing, In-Use Studies, Photostability, Comparative/Comparator Stability, Follow Up Stability Testing (FUST), Formulation Evaluation Stability, Finished Product Release, Cycling Chamber Stability Studies etc.

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    Acceleration Laboratory Services

    Aizant Drug Research Solutions Pvt. Ltd.

    CARBOGEN AMCIS AG

    Cebiphar

    ChemCon GmbH

    Crenza Pharma

    Dalton Pharma Services

    Dishman Carbogen Amcis

    Eurofins CDMO

    GRAM Laboratory Inc

    GVK Biosciences

    Lamda Laboratories

    Lubrizol Life Science Health

    Malladi Drugs & Pharmaceuticals Limited

    Megsan Labs Private Limited

    Mithra CDMO

    Neopharm Labs Inc

    One Pharma S.A

    Pace Analytical Services, LLC

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    Malladi Drugs & Pharmaceuticals Limited

    • FDA
    • EDQM
    • WHO-GMP

    Virtual BoothUSFDA, EDQM, ANSM, KFDA, TGA Inspected// in 60 countries // Ephedrine, Pseudoephedrine Salts & Phenylephrine HCl

    INDIA India

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    Photostability Studies

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    Malladi-Photostability-Studies

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    Malladi’s R&D is well-equipped with a wide range of process & analytical capabilities such as method & development and validation for API, stability including stability studies, photostabiltiy studies, stress testing & degradation profiling.

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    Pharma Service: Analytical

    Category: Stability Studies

    Sub Category: Photostability

    Eurofins CDMO

    • FDA
    • EDQM

    Virtual BoothYour Drug Development partner of drug substance/API and Drug Product Operations for biologics and small molecules.

    FRANCE France

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    CPhI Japan

    1K-79

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    Photostability Studies

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    Eurofins-CDMO-Photostability-Studies

    - Service Details

    We perform ICH compliant stability studies including stress studies, accelerated and long-term stability studies to support regulatory CMC programs and process development.

    - Directory Listing

    Pharma Service: Analytical

    Category: Stability Studies

    Sub Category: Photostability

    RECRO GAINESVILLE

    • FDA
    • EDQM

    Virtual BoothExperts in Development and Manufacturing Solutions for Oral Solid Dosage Forms

    UNITED STATES United States

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    PODD: Partnerships in Drug Delivery

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    ICH Stability/Photo Stability Testing

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    - Service Details

    Recro provides various analytical testing services including raw material, in-process & finished product release testing, ICH stability testing, photo stability, physiochemical characterization, method development & validation, residual solvents by GC.

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    Pharma Service: Analytical

    Category: Stability Studies

    Sub Category: Photostability

    Softigel Procaps

    • FDA
    • EDQM

    Virtual BoothA leading provider of Contract Development and Manufacturing services in softgel advanced technologies for the global market.

    COLOMBIA Colombia

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    BE PHARMA 2020

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    Photo Stability Studies

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    Softigel-Photo-Stability-Studies

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    Our R&D services include Drug substance, clinical trial materials, IND, NDA & ANDA registration stability testing, All ICH climatic stability zones, Photostability chamber, Forced degradation studies, Computerized data management & pull schedules, etc

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    Pharma Service: Analytical

    Category: Stability Studies

    Sub Category: Photostability

    QUINTA-ANALYTICA s.r.o

    • FDA
    • EDQM

    Virtual BoothGlobal provider of comprehensive top services in the field of Drug Testing, Clinical Trials & Bioanalytical Services.

    CZECH REPUBLIC Czech Republic

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    IFT Annual Expo

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    Photostability Studies

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    - Service Details

    Quinta-Analytica has been providing a complete service of stability studies with active substances and dosage forms. Also these studies are conducted within the GMP framework and according to the ICH guidelines with photostabiity chambers

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    Pharma Service: Analytical

    Category: Stability Studies

    Sub Category: Photostability

    WellSpring

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      CANADA Canada

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      IFT Annual Expo

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      Photostability Studies

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      - Service Details

      Our scientists at WellSpring have years of experience using advanced analytical equipment to ensure precision during all our testing procedures. Our facility is fully equipped with modern chemistry and microbiology laboratories that operate beyond cGMP standards.

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      Pharma Service: Analytical

      Category: Stability Studies

      Sub Category: Photostability

      Crenza Pharma

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        INDIA India

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        IFT Annual Expo

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        Photo Stability Studies

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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.

        - Directory Listing

        Pharma Service: Analytical

        Category: Stability Studies

        Sub Category: Photostability

        Pace Analytical Services, LLC

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          UNITED STATES United States

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          IFT Annual Expo

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          Photostability Studies

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          - Service Details

          Pace Analytical provides secure long- and short-term (accelerated) storage and stability testing to support your cGMP stability programs. We offer a broad range of conditions temperature only, temperature and humidity, photostability, cycling and freeze/thaw that supports ICH guidelines.

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          Pharma Service: Analytical

          Category: Stability Studies

          Sub Category: Photostability

          One Pharma S.A

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            GREECE Greece

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            IFT Annual Expo

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            Photostability and In-use stability

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            - Service Details

            The R&D Department is staffed with fully trained and highly experienced scientists and has at its disposal state-of-the-art facilities striving to produce products according to GMP/GLP global standards.

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            Pharma Service: Analytical

            Category: Stability Studies

            Sub Category: Photostability

            Acceleration Laboratory Services

            • FDA

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            UNITED STATES United States

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            ICH Photostability

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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: Stability Studies

            Sub Category: Photostability

            SEQUENT SCIENTIFIC LTD

            • FDA
            • WHO-GMP

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            INDIA India

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            IFT Annual Expo

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            Photo stability (UV & Daylight) per ICH Q1B

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            - Service Details

            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.

            - Directory Listing

            Pharma Service: Analytical

            Category: Stability Studies

            Sub Category: Photostability

            GRAM Laboratory Inc

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              UNITED STATES United States

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              Photostability Evaluation

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              - Service Details

              GRAM Laboratories offers services for conduct of preformulation studies. These studies are performed to gather in-depth knowledge about the physical and chemical characteristics of the active ingredient and eventually aid in the development and optimization.

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              Pharma Service: Analytical

              Category: Stability Studies

              Sub Category: Photostability

              Dishman Carbogen Amcis

              • FDA
              • EDQM
              • WHO-GMP

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              INDIA India

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              IFT Annual Expo

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              Stressing Tests & Photostability Studies

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              - Service Details

              Dishman offers various analytical services under Stability which includes ICH Stability Studies, Stressing Studies, Photostability Studies, Drug Substance & Drug Product Stability and Degradation profiling.

              - Directory Listing

              Pharma Service: Analytical

              Category: Stability Studies

              Sub Category: Photostability

              Mithra CDMO

              • EDQM

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              BELGIUM Belgium

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              IFT Annual Expo

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              Drug Product Photostability Studies

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              - Service Details

              We offer stability testing under International Conference on Harmonization (ICH) conditions and custom conditions.

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              Pharma Service: Analytical

              Category: Stability Studies

              Sub Category: Photostability

              RD Laboratories

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                UNITED STATES United States

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                IFT Annual Expo

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                Photostability Studies

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                - Service Details

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

                - Directory Listing

                Pharma Service: Analytical

                Category: Stability Studies

                Sub Category: Photostability

                Neopharm Labs Inc

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                  CANADA Canada

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                  IFT Annual Expo

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                  Photostability (ICH Q1B, Option II)

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                  - Service Details

                  Neopharm offers a full range of stability testing and storage services to meet the performance needs of our clients. Our stability operations include 15,000 cubic feet of walk-in/reach-in chambers/incubators that meet the ICH guidelines requirements.

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                  Pharma Service: Analytical

                  Category: Stability Studies

                  Sub Category: Photostability

                  Ropack Inc

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                    UNITED STATES United States

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                    Virtual Booth Virtual Booth

                    IFT Annual Expo

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                    Photostabilty

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                    - Service Details

                    ICH-compliant stability storage temperatures and, where applicable, humidity control, with many intermediate options available.

                    - Directory Listing

                    Pharma Service: Analytical

                    Category: Stability Studies

                    Sub Category: Photostability

                    Aizant Drug Research Solutions Pvt. Ltd.

                    • WHO-GMP

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                    INDIA India

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                    IFT Annual Expo

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                    Photo Stability Studies

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                    - Service Details

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

                    - Directory Listing

                    Pharma Service: Analytical

                    Category: Stability Studies

                    Sub Category: Photostability

                    Lamda Laboratories

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                      GREECE Greece

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                      IFT Annual Expo

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                      Photostability Studies

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                      - Service Details

                      Lamda’s analytical options are available on a stand-alone bases or as part of a full development package such as Analytical method development & Validation, Forced degradation studies, Photostability studies, Method transfer, API controls etc

                      - Directory Listing

                      Pharma Service: Analytical

                      Category: Stability Studies

                      Sub Category: Photostability

                      Megsan Labs Private Limited

                      • Audit Compliance

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                      INDIA India

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                      Photostability

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                      - Service Details

                      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

                      - Directory Listing

                      Pharma Service: Analytical

                      Category: Stability Studies

                      Sub Category: Photostability

                      Stason Pharmaceuticals, Inc.

                      • FDA

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                      UNITED STATES United States

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                      Photostability of API

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                      - Service Details

                      Characterization studies for your product can be conducted prior to formulation. We specialize in the design and execution of pertinent pre-formulation activities required for successful pharmaceutical product development.

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                      Pharma Service: Analytical

                      Category: Stability Studies

                      Sub Category: Photostability

                      Stason Pharmaceuticals, Inc.

                      • FDA

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                      Matrix Stability Evaluations

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                      - Service Details

                      Characterization studies for your product can be conducted prior to formulation. We specialize in the design and execution of pertinent pre-formulation activities required for successful pharmaceutical product development.

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                      Pharma Service: Analytical

                      Category: Stability Studies

                      Sub Category: Photostability

                      Stason Pharmaceuticals, Inc.

                      • FDA

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                      QC Testing & Stability Monitoring

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                      - Service Details

                      Stason has quality control systems, which require strict adherence to cGMP regulations. Total system quality is monitored from sample receipt to report generation. Offers QC testing for API’s, pharmaceutical intermediates, excipients & finished products.

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                      Pharma Service: Analytical

                      Category: Stability Studies

                      Sub Category: Photostability

                      ChemCon GmbH

                      • FDA
                      • EDQM

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                      GERMANY Germany

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                      Photostability Testing

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                      - Service Details

                      ChemCon carries out ICH-compliant stress and stability programs.

                      - Directory Listing

                      Pharma Service: Analytical

                      Category: Stability Studies

                      Sub Category: Photostability

                      Lubrizol Life Science Health

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                        UNITED STATES United States

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                        IFT Annual Expo

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                        Photostability Analysis

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                        - Service Details

                        Our services include Development of stability indicating methods, photostability, accelerated and long-term stability programs.

                        - Directory Listing

                        Pharma Service: Analytical

                        Category: Stability Studies

                        Sub Category: Photostability

                        CARBOGEN AMCIS AG

                        • FDA
                        • EDQM

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                        SWITZERLAND Switzerland

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                        IFT Annual Expo

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                        Forced Degradation Studies & Stress Tests

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                        At CARBOGEN AMCIS AG, we can perform forced degradation tests, stress tests, and stability studies according to the International Conference on Harmonisation (ICH) guidelines.

                        - Directory Listing

                        Pharma Service: Analytical

                        Category: Stability Studies

                        Sub Category: Photostability

                        Dalton Pharma Services

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                          CANADA Canada

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                          IFT Annual Expo

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                          Photostability

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                          - Service Details

                          Dalton supports its customers' products with our in-house stability services including full stability services from protocol development for accelerated stability, intermediate term stability and long term stability programs.

                          - Directory Listing

                          Pharma Service: Analytical

                          Category: Stability Studies

                          Sub Category: Photostability

                          GVK Biosciences

                          • FDA
                          • EDQM

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                          INDIA India

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                          Photo-Stability

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                          - Service Details

                          GVK BIO performs stability analysis of drug products and active ingredient (APIs), packaging as per ICH, quality control testing and release as per cGMP requirements.

                          - Directory Listing

                          Pharma Service: Analytical

                          Category: Stability Studies

                          Sub Category: Photostability

                          Cebiphar

                          • FDA
                          • EDQM
                          • Audit Compliance

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                          FRANCE France

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                          Photostability Studies

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                          - Service Details

                          Is the drug substance/product sensitive to light? Is this impact acceptable ? Are precautionary measures needed in manufacturing? Is a light resistant packaging mandatory? For all those questions, CEBIPHAR provides its support from protocol up to analyses

                          - Directory Listing

                          Pharma Service: Analytical

                          Category: Stability Studies

                          Sub Category: Photostability

                          Analytical testing is a critical part in every step of drug development and manufacturing. The qualitative and quantitative results generated from validated analytical testing provide first-hand information to control and ensure the quality and safety of raw materials, intermediates, and finished products. Like many other CMC (chemical, manufacturing and control) activities, analytical testing is also frequently outsourced. Many factors are attributed to this rapid market growth, including continuous outsourcing from pharmaceutical companies, growing pipelines for biological candidates, and increasing demand for more analytical details on drugs and process development by regulatory agencies. In response to the changing market dynamics, service providers are striving to provide analytical testing with quality, accuracy, and robustness all within tight timelines. As the contract research organizations (CROs) have become more integrated, small analytical labs need to establish their niche to succeed. Global contract analytical Laboratories provide QC laboratory analysis, method development, validation and expert advice for both finished products and raw materials for pharmaceutical and biopharmaceutical companies. Stability assay methods should be specific enough to differentiate between analytes and possible degradation products. The overall quality of drug-substance and drug-product batches placed on formal stability studies should represent the quality of materials used in clinical studies and of the quality of materials to be made at manufacturing scale. Supporting stability data can be provided using stability data generated from batches of drug substances and drug products made on a laboratory scale. Stability studies also should be conducted on material stored in a container–closure system that is the same as (or simulates) packaging proposed for real storage and distribution. Stability Studies are performed to understand the compounds/formulation in development: Physical & Chemical properties of API and drug product, Drug and excipient compatibility, Impact of manufacturing process steps, Interactions with packaging materials, Assignment of shelf life etc. Analytical stability programs for a drug substance or drug product also can be used for the characterization of impurities and related substances in line with dissolution studies, and to residual solvents, disintegration, and friability. Testing can be performed at ambient temperature, accelerated conditions, intermediate conditions, and other storage conditions. cGMP stability analyses include ICH Stability Services, Real-Time & Long Term Stability, Accelerated Stability, Forced Degradation Studies, Stress Stability Testing, R&D Stability Testing, In-Use Studies, Photostability, Comparative/Comparator Stability, Follow Up Stability Testing (FUST), Formulation Evaluation Stability, Finished Product Release, Cycling Chamber Stability Studies etc.

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