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Primera Analytical Solutions Corp.
   Founded in 2002.

   Strong, solid, steady
    organic growth.

   Strong base of PhD level
    scientists heading our
    groups.

   Working relationships
    with many international
    and domestic
    pharmaceutical
    enterprises


                               Primera Analytical Solutions Corp.
   GMP Analytical

   Release Testing

   Bioanalysis of Clinical
    Samples

   Formulation Development

   GMP Analytical Method
    Development, Validation

   Stability Testing/Stability
    Indicating Method
    Development.

   Method Transfer
                                  Primera Analytical Solutions Corp.
0.120
    UPLC/HPLC Experience




                                                                              30.010

                                          0.110
       SEC/GPC                           0.100

       Ion Exchange                      0.090

       Chiral Methods                    0.080

       Conventional Reverse Phase        0.070




                                     AU
       Conventional Normal Phase         0.060

                                          0.050

                                          0.040
   SDS PAGE                              0.030

                                          0.020




                                                                    25.705



                                                                                        34.683
    GC/FID, GC/MS, GC
                                          0.010

                                          0.000
    Headspace                                0.00   10.00   20.00            30.00               40.00   50.00   60.00   70.00
                                                                                       Minutes



   HPLC Detection Systems
       CAD
       ELSD
       DAD
       RI                                                                         Primera Analytical Solutions Corp.
Mass Spectroscopy Laboratory
                     Bioanalysis of Clinical
                       Trial/BE Samples

                         Method Transfer

                       Method Development

                        Method Validation

                         Clinical Partners


                             Primera Analytical Solutions Corp
      Characterization of Proteins
                 and Peptides

                                         30.010
     0.0045


     0.0040
                               25.705




     0.0035


     0.0030


     0.0025


                                                                                         SDS PAGE
AU




     0.0020                                                                     
     0.0015                                                                             ELISA
                                                  34.683




     0.0010                                                                             Protein Stability Studies
     0.0005                                                                             Peptide Mapping with HPLC or LC/MS/MS
     0.0000
                                                                                        Amino Acid Analysis
                                                                                         Chiral Edman Degradation
     -0.0005
               10.00   20.00            30.00           40.00   50.00   60.00
                                                                                70.00

                                                                                         qPCR
                                                  Minutes
                                                                                

                                                                                        Cell Viability Assays.
                                                                                        Endotoxins…



                                                                                                        Primera Analytical Solutions Corp.
Preformulation

Physicochemical Properties

Particle size analysis

Solubility profile

pH and pKa determination

Solid and solution state
stability

Drug-excipient compatibility

Drug-drug compatibility
(combination drugs)


                                Primera Analytical Solutions Corp.
Our Facilities Include:
 ICH Stability Chambers



   Photostability Chamber

   Full Power Back Up

   -70C, -20C Freezers.

   24/7 Alarms: Cellphone/
    Online Veriteq System

   Unique Conditions Capability
                                   Primera Analytical Solutions Corp.
   Robust System of SOP’s

   Full GLP/GMP Staff
    Training Program

   Secure Data Backup

   FDA Audited 2008
   and 2012

   No 483’s



                             Primera Analytical Solutions Corp.
Primera Analytical Solutions Corp.
Thank You!!!


Primera Analytical Solutions Corp.


          259 Wall Street
        Princeton, NJ 08540
          (609) 921-7715

       www.primera-corp.com

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21 quantitative lc-msms analysis of 15 estrogens and estrogen metabolites in human plasma using supported liquid extraction (sle) technique steve cines - primera analytical solutions

  • 2. Founded in 2002.  Strong, solid, steady organic growth.  Strong base of PhD level scientists heading our groups.  Working relationships with many international and domestic pharmaceutical enterprises Primera Analytical Solutions Corp.
  • 3. GMP Analytical  Release Testing  Bioanalysis of Clinical Samples  Formulation Development  GMP Analytical Method Development, Validation  Stability Testing/Stability Indicating Method Development.  Method Transfer Primera Analytical Solutions Corp.
  • 4. 0.120 UPLC/HPLC Experience 30.010  0.110  SEC/GPC 0.100  Ion Exchange 0.090  Chiral Methods 0.080  Conventional Reverse Phase 0.070 AU  Conventional Normal Phase 0.060 0.050 0.040  SDS PAGE 0.030 0.020 25.705 34.683 GC/FID, GC/MS, GC 0.010  0.000 Headspace 0.00 10.00 20.00 30.00 40.00 50.00 60.00 70.00 Minutes  HPLC Detection Systems  CAD  ELSD  DAD  RI Primera Analytical Solutions Corp.
  • 5. Mass Spectroscopy Laboratory Bioanalysis of Clinical Trial/BE Samples Method Transfer Method Development Method Validation Clinical Partners Primera Analytical Solutions Corp
  • 6. Characterization of Proteins and Peptides 30.010 0.0045 0.0040 25.705 0.0035 0.0030 0.0025 SDS PAGE AU 0.0020  0.0015  ELISA 34.683 0.0010  Protein Stability Studies 0.0005  Peptide Mapping with HPLC or LC/MS/MS 0.0000  Amino Acid Analysis Chiral Edman Degradation -0.0005 10.00 20.00 30.00 40.00 50.00 60.00 70.00 qPCR Minutes   Cell Viability Assays.  Endotoxins… Primera Analytical Solutions Corp.
  • 7. Preformulation Physicochemical Properties Particle size analysis Solubility profile pH and pKa determination Solid and solution state stability Drug-excipient compatibility Drug-drug compatibility (combination drugs) Primera Analytical Solutions Corp.
  • 8. Our Facilities Include:  ICH Stability Chambers  Photostability Chamber  Full Power Back Up  -70C, -20C Freezers.  24/7 Alarms: Cellphone/ Online Veriteq System  Unique Conditions Capability Primera Analytical Solutions Corp.
  • 9. Robust System of SOP’s  Full GLP/GMP Staff Training Program  Secure Data Backup  FDA Audited 2008  and 2012  No 483’s Primera Analytical Solutions Corp.
  • 11. Thank You!!! Primera Analytical Solutions Corp. 259 Wall Street Princeton, NJ 08540 (609) 921-7715 www.primera-corp.com