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    The pharmaceutical industry is heavily regulated beyond all other industries. This is for a good reason because many of the materials produced are potentially dangerous and can be severely toxic if not manufactured with proper care. Regulation has led to the mandatory examination of all substances from starting materials to finished products. Generally this includes the proof of product stability, drug-release profiles, Active Pharmaceutical-Ingredient (API) form, API quantification, and product

    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 Renejix (1)

    02 ACTA Laboratories Inc (3)

    03 Anacipher (1)

    04 Aragen Life Sciences (1)

    05 Arbro Pharmaceuticals Pvt. Ltd (1)

    06 Arevipharma (2)

    07 Boston Analytical (2)

    08 CARBOGEN AMCIS AG (1)

    09 Cebiphar (1)

    10 Chemtos (1)

    11 Dalton Pharma Services (1)

    12 Diverchim S.A. (1)

    13 Doctor's Analytical Laboratories (1)

    14 GRAM Laboratory Inc (1)

    15 Grace (1)

    16 Jubilant HollisterStier (1)

    17 Labiana Life Sciences S.A (1)

    18 Megsan Labs Private Limited (1)

    19 Nutrasource (1)

    20 Pace Analytical Services, LLC (1)

    21 Primera Analytical Solutions Corp (1)

    22 Quantex Laboratories (1)

    23 RD Laboratories (3)

    24 SEQUENT SCIENTIFIC LTD (1)

    25 Servier (1)

    26 Shijiazhuang Rainbowlabs Pharmaceutical Technology (1)

    27 Siegfried AG (1)

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    01 Canada (2)

    02 China (1)

    03 France (3)

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    05 India (6)

    06 Spain (1)

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    08 U.S.A (16)

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    Renejix

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      ELEMENTAL & HEAVY METAL ANALYSIS

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      Renejix offers analytical testing services including trace, elemental, or heavy metal analysis, UV spectrophotometry, XRPD, TGA, and NMR-proton.

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      Pharma Service: Analytical

      Category: Analytical Testing Services

      Sub Category: Trace / Elemental / Heavy Metals

      Elemental & Heavy Metal Analysis

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      ACTA Laboratories Inc

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        HEAVY METALS TESTING USP <231>, <232>, AND <233>

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        ACTA Laboratories, Inc. is a cGMP FDA Registered Testing Laboratory that performs USP <231> (wet chemistry testing for heavy metals) and USP <232>/<233> (ICP-MS testing for Elemental Impurities) on Pharmaceutical APIs (Active Pharmaceutical Ingredients) and Drug Products.

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        RD Laboratories

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          ELEMENTAL ANALYSIS

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          R.D. Laboratories has significant expertise and a variety of specialized equipment to assist with inorganic impurity testing.

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          ACTA Laboratories Inc

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            USP <231> HEAVY METALS TESTING

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            The current procedure in the USP for Heavy Metals testing is a wet chemistry test that utilizes sulfide to precipitate certain heavy metals (Pb, Hg, Bi, As, Sb, Sn, Cd, Ag, Cu, and Mo). The test sample preparation is visually examined to see if it is darker than the standard.

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            Pharma Service: Analytical

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            Arbro Pharmaceuticals Pvt. Ltd

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              LIMIT TESTS FOR HEAVY METALS

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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

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              ACTA Laboratories Inc

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                USP <232> ELEMENTAL IMPURITIES – LIMITS

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                The new ICP-MS procedures are quantitative and will provide an accurate assessment of elemental impurities. The USP <232> Elemental Impurities Limits lists the proposed limits for allowable levels of elemental impurities in drug products and drug substances.

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                Pharma Service: Analytical

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                Quantex Laboratories

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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

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                  Primera Analytical Solutions Corp

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                  HEAVY METAL ANALYSIS BY ICP/MS

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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

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                  Nutrasource

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                    HEAVY METALS TESTING

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                    To ensure your product complies with the regulations, we offer testing for most metals via ICP-MS equipment providing very low detection limits.

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                    Shijiazhuang Rainbowlabs Pharmaceutical Technology

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                      HEAVY METAL TEST

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                      Shijiazhuang Rainbowlabs pharmaceutical Technology Co. Ltd (Rainbowlabs) is a FDA-inspected laboratory set up to provide high quality laboratory testing and services to pharmaceutical companies throughout the world.

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                      Pharma Service: Analytical

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                      Chemtos

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                        COMBUSTION ELEMENTAL ANALYSIS

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                        Chemtos' other analysis that are available upon request include Combustion Elemental Analysis

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                        SEQUENT SCIENTIFIC LTD

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                        ELEMENTAL ANALYSIS -TRACE METAL ANALYSIS

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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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                        RD Laboratories

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                          MERCURY TRACING

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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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                          Arevipharma

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                          TRACE ANALYSIS

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                          Arevipharma develops, validates and transfers new methods of analysis, this is done also in the field of trace analysis, e.g. for potential genotoxic substances. Thorough reporting is included, of course.

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                          RD Laboratories

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                            SELENIUM TRACING

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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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                            Boston Analytical

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                              ELEMENTAL ANALYSIS VIA INDUCTIVELY COUPLED PLASMA

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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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                              Arevipharma

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                              DETERMINATION OF ELEMENTS

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                              Arevipharma puts focus on the process development of stable and robust chemical synthesis routes, and its quality management to ensure its Active Pharmaceutical Ingredients (API) are of the highest quality.

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                              GRAM Laboratory Inc

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                                COMPATIBILITY WITH METAL IONS

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                                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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                                Boston Analytical

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                                  PARTICULATE ANALYSIS – USP <788> AND USP <789>

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                                  Boston Analytical offers an extensive line of microbiological testing services for pharmaceuticals. Our FDA/DEA Registered, cGMP compliant, and ISO/IEC-17025:2005 certified laboratory is well equipped with the latest technology and instrumentation, ensuring timely and accurate testing results.

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                                  Anacipher

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                                    TRACE ANALYSIS & CARRY OVER STUDIES

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                                    Trace analysis of impurities like organic, inorganic and residual solvents and their carry over in the finished product can be performed as per regulatory requirements. The report with suitability of the method along with the limits of detection and quantification.

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                                    Doctor's Analytical Laboratories

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                                      ANALYTICAL TESTING FOR HEAVY METALS

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                                      DALPL offers routine and advanced analytical testing services for impurities & contaminants, heavy metals, microbiology preservatives, chemico-physical analysis, residue analysis, vitamins, etc.

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                                      Megsan Labs Private Limited

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                                      ELEMENTAL ANALYSIS

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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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                                      Pace Analytical Services, LLC

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                                        ELEMENTAL IMPURITIES 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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                                        Labiana Life Sciences S.A

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                                        TRACE ANALYSIS IN SURFACE CONTROLS

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                                        In the analytical development area, LABIANA GROUP offers a wide range of services for pharmaceutical and veterinary industries.

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                                        Diverchim S.A.

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                                        ELEMENTARY ANALYSIS & COULOMETRY

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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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                                        Grace

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                                          ICP-OES

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                                          Grace Albany Fine Chemicals' site is designed to meet customers' highest quality, regulatory, and confidentiality expectations for the manufacture of fine chemicals and intermediates.

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                                          CARBOGEN AMCIS AG

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                                          PROCESS CONTROL & MATERIAL CHARACTERIZATION

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                                          Carbogen Amcis SAS has established a service supporting our customers with crystallization investigations including solubility tests, salt screening, and optimization of the crystallization process and the solid-liquid separation in the API isolation process.

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                                          Servier

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                                          METAL DETECTION

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                                          Servier CDMO has the capabilities to deliver your project from development through to the manufacture of large commercial batch sizes of tablets, capsules or powders. Servier has 60 years of experience with a proven track record of quality and regulatory approval to ensure reliability for your

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                                          Jubilant HollisterStier

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                                          METALS ANALYSIS BY ICP

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                                          Jubilant HollisterStier’s innovative microbiological and analytical labs are operated by experienced professionals using the most current equipment and procedures to ensure seamless technical transfer of analytical methods for our clients.

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                                          Dalton Pharma Services

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                                            ICP-MS ELEMENTAL ANALYSIS

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                                            In accordance with the updated ICH Q3D Guideline for Elemental Impurities, Dalton now offers ICP-MS testing services.

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                                            Siegfried AG

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                                            HEAVY METAL DETERMINATION

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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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                                            Aragen Life Sciences

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                                            CHNS ANALYSER - ELEMENTOR

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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 Testing Services

                                            Sub Category: Trace / Elemental / Heavy Metals
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                                            SPECTROPHOTOMETRY

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                                            Our technical platforms encompasses, among others: UV-visible spectrophotometers, infra-red spectrometer, atomic absorption spectrophotometer (SAA) flame & oven, colorimeter.

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                                            Pharma Service: Analytical

                                            Category: Analytical Testing Services

                                            Sub Category: Trace / Elemental / Heavy Metals
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                                            US
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                                            your Marketing & Sales content
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