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    Pharma Services Category of Quantex Laboratories

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    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 Analytical Method Development (3)

    02 Analytical Testing Services (5)

    03 Extractables and Leachables (1)

    04 Stability Studies (1)

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    01 Quantex Laboratories (10)

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    01 U.S.A (10)

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    Quantex Laboratories

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      METHOD DEVELOPMENT & VALIDATION

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      Quantex Laboratories provides cost effective outsourced cGMP and GLP laboratory services to industry. Analytical methods developed include procedures for active pharmaceutical ingredients (APIs), drug formulations, cosmetics, personal care producuts, and raw materials.

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      Pharma Service: Analytical

      Category: Analytical Method Development

      Sub Category: Method Development and Validation
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        PRODUCT QUALITY CONTROL & RELEASE TESTING

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        Quantex Laboratories supports your product Quality Control and Release Testing needs for Active Ingredients intermediates, excipients and finished products. We have experience testing for many types of formulations.

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        Pharma Service: Analytical

        Category: Analytical Testing Services

        Sub Category: Batch Release and Stability Lot Testing
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          cGMP COMPENDIAL / RAW MATERIALS TESTING

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          Quantex Laboratories performs comprehensive analytical testing of raw materials, APIs, excipients and FDFs. Compendial testing is performed in accordance with USP/NF, BP, EP, JP, ACS and FCC methodologies and monographs, as well as with client-supplied or vendor-specified methods.

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          Pharma Service: Analytical

          Category: Analytical Testing Services

          Sub Category: Complete Pharmacopoeial / Compendial Testing
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            RESIDUAL SOLVENTS

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            We have systems capable of performing the current USP monograph for Residual Solvents using dedicated HS-GC-FID systems. We can also perform residual solvent analysis by headspace GC/MS.

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            Pharma Service: Analytical

            Category: Analytical Testing Services

            Sub Category: Residual Solvents
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              TRACE, HEAVY METALS & ELEMENTAL IMPURITIES TESTING

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              For 25 years Quantex has been involved with developing and executing methods for trace and heavy metals analysis employing modern quantitative technologies.

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              Pharma Service: Analytical

              Category: Analytical Testing Services

              Sub Category: Trace / Elemental / Heavy Metals
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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

                Category: Extractables and Leachables

                Sub Category: Testing Services
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                  STABILITY AND SHELF LIFE SERVICES

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                  Quantex Laboratories offers a complete range of stability testing services to assist you with your stability testing requirements. We have numerous temperature and humidity conditions available in our qualified stability storage chambers, including all conditions needed to comply with the ICH

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                  Pharma Service: Analytical

                  Category: Stability Studies

                  Sub Category: Overview
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                    PHARMACEUTICAL METHOD DEVELOPMENT AND VALIDATION OF PRO...

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                    Our laboratory has 25 years of in depth experience with designing and executing method development and validation, verification and method transfer protocols and experiments.

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                    Pharma Service: Analytical

                    Category: Analytical Method Development

                    Sub Category: Method Development and Validation
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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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                        USP AND EP PURIFIED WATER TESTING

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                        The water used for manufacturing, cleaning, cooling, and filtration must be pure to ensure that your product is not contaminated. Our experienced and well versed scientists can help you determine the specific USP/EP purified water testing needed for your water systems.

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                        Pharma Service: Analytical

                        Category: Analytical Testing Services

                        Sub Category: Pharmaceutical Water
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