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    Pharma Services Category of Boston Analytical

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    01 Analytical Method Development (3)

    02 Analytical Testing Services (20)

    03 Extractables and Leachables (1)

    04 Stability Studies (1)

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    01 Boston Analytical (25)

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    01 U.S.A (25)

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    Boston Analytical

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      METHOD DEVELOPMENT & VALIDATION

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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: Method Development and Validation
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        ANALYTICAL TESTING - RAW MATERIALS

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        Boston Analytical is an analytical testing laboratory that provides pharmaceutical analysis for drug development, analytical development & microbiology testing. It provides analytical solutions along with analytical testing services for CMC parameters.

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        Pharma Service: Analytical

        Category: Analytical Testing Services

        Sub Category: Overview
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          IN-PROCESS AND LOT RELEASE TESTING

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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 Testing Services

          Sub Category: Batch Release and Stability Lot Testing
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          Boston Analytical

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            STABILITY TESTING & STORAGE SUPPORT

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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 Testing Services

            Sub Category: Batch Release and Stability Lot Testing
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              USP COMPLIANCE PRODUCT TESTING

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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 Testing Services

              Sub Category: Complete Pharmacopoeial / Compendial Testing
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                CLEANING VALIDATION

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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 Testing Services

                Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)
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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

                  Sub Category: Impurity Isolation and Identification
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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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                      FINISHED PRODUCT RELEASE

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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 Testing Services

                      Sub Category: Batch Release and Stability Lot Testing
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                        DISSOLUTION ANALYSIS (APPARATUS I – V & VII)

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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 Testing Services

                        Sub Category: Dissolution
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                          RESIDUAL SOLVENTS

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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 Testing Services

                          Sub Category: Residual Solvents
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                            HPLC & GC WITH VARIOUS DETECTORS

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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 Testing Services

                            Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)
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                              WATERS UPLC® (ULTRA PERFORMANCE LIQUID CHROMATOGRAPHY...

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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 Testing Services

                              Sub Category: Chromatography (TLC / LC / HPLC / UPLC / GC)
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                                USP MONOGRAPH TESTING

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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 Testing Services

                                Sub Category: Complete Pharmacopoeial / Compendial Testing
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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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                                  Pharma Service: Analytical

                                  Category: Analytical Testing Services

                                  Sub Category: Trace / Elemental / Heavy Metals
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                                    CLASS 100 GLOVE BOX ISOLATOR WITH VHP STERILIZATION SYS...

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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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                                    Pharma Service: Analytical

                                    Category: Analytical Testing Services

                                    Sub Category: Microbiology
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                                      DIRECT INOCULATION TESTING UNDER USP/EP GUIDELINES

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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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                                      Pharma Service: Analytical

                                      Category: Analytical Testing Services

                                      Sub Category: Microbiology
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                                        ENDOTOXIN TESTING UNDER USP/EP GUIDELINES

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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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                                        Pharma Service: Analytical

                                        Category: Analytical Testing Services

                                        Sub Category: Microbiology
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                                          WATER TESTING- USP <1231>, USP <643>, USP <645>

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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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                                          Pharma Service: Analytical

                                          Category: Analytical Testing Services

                                          Sub Category: Pharmaceutical Water
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                                            MICROBIAL ENUMERATION TESTING – USP <61>

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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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                                            Pharma Service: Analytical

                                            Category: Analytical Testing Services

                                            Sub Category: Microbiology
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                                              ANTIMICROBIAL EFFECTIVENESS TESTING – USP <51>

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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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                                              Pharma Service: Analytical

                                              Category: Analytical Testing Services

                                              Sub Category: Microbiology
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                                                BIOLOGICAL INDICATOR TESTING – USP <55> AND USP <1035...

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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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                                                Pharma Service: Analytical

                                                Category: Analytical Testing Services

                                                Sub Category: Microbiology
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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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                                                  Pharma Service: Analytical

                                                  Category: Analytical Testing Services

                                                  Sub Category: Trace / Elemental / Heavy Metals
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                                                    EXTRACTABLES & LEACHABLES ANALYSIS

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                                                    Boston Analytical's staff has experience evaluating Extractables & Leachables in pharmaceutical packaging, medical devices, drug-delivery/combination products, processing equipment, Single Use Systems, e-cigarettes, and consumer product packaging.

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                                                    Pharma Service: Analytical

                                                    Category: Extractables and Leachables

                                                    Sub Category: Testing Services
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                                                      ICH & FDA COMPLIANT STABILITY TESTING FOR DRUG DEVELOPM...

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                                                      Our stability samples are housed in ICH compliant storage chambers. All chambers and rooms are mapped, monitored for temperature and humidity, alarmed, and backed up with emergency power to ensure accurate results.

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                                                      Pharma Service: Analytical

                                                      Category: Stability Studies

                                                      Sub Category: Overview
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