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LC-IR Hyphenated Technology for
       Excipient Analysis
         FDA on Jan. 12, 2010

         USP on Jan. 13, 2010
      George Giansanti, Tom Kearney

          Gerrit Blok, Ming Zhou

          Spectra Analysis, Inc.
                                      1
OUTLINE



Introduction: Company & LC-IR Technology

DiscovIR-LC System: Instrumentation & Features

Applications of LC-IR: Case Studies

Q&A




                                                 2
The Company
257 Simarano Drive
Marlborough, MA 01752




Completed product engineering
with patent protected ‘breakthrough’
technology during 2005 & 2006.

Initiated sales and began building a ‘top tier’ customer base, 2007 thru 2009.

Received R&D Magazine’s ‘Top 100’ product Award, 2008.

Received Massachusetts Life Science Center, Certification & Award, 2009.

Spectra has great people, ‘breakthrough’ products, huge market and is positioned for
explosive growth !


                                       December 2009                               3
Meet the Spectra Team




 George Giansanti          William W. Carson, PE        Ming Zhou, PhD.           Tom Kearney, MBA
  President & CEO             Sr. VP Engineering     Applications Engrg. Mgr.     Technical Sales Mgr.
      Cal Poly                        MIT               Univ. Connecticut            Univ. Vermont




Sidney Bourne, PhD.            Andrew Chung               David Dunn                   Stacy Follo
Sr. VP & Chief Scientist      Product Engineer       Sr. Applications Chemist      Southeast Sales Rep.
    Univ. Wisconsin             Northeastern               Northeastern                Northeastern

 Part time support:
 Lisa Velardo, CPA – CFO
                                                             Gerrit Blok
                                                        Mid-Atlantic Sales Rep.
 Cheryl McCarthy – Accountant
                                                            Broek Institute,
 Amy Guyton – Materials & Logistics
                                                             Amsterdam
 James Dwyer, PhD. – Technical Advisor
DiscovIR Users

Merck                               Pharma
Johnson & Johnson                   Pharma
Novartis                            Pharma
Shire Pharmaceuticals               Pharma
Du Pont                             Polymers
Dow Chemical                        Polymers
Lawrence Livermore National Lab     Trace Analysis
Oak Ridge National Laboratory       Environmental
Naval Research Laboratory           Organics
US Army Aberdeen Proving Ground     Forensics
Pennsylvania State Police           Forensics
Alabama Department of Forensics     Forensics
Vermont State Police Forensic lab   Forensics
DiscovIR Product Line

                         Separate→Concentrate→Identify
                       DiscovIR-GCTM                    DiscovIR-LCTM
                                                        2008 Award Winner
Applications:                                                                     Applications:
General Analytical
Capability                                                                        Excipients
Forensic Labs                                                                     Polymers
(Controlled
Substance Analysis)                                                               Advanced
                                                                                  Materials




                      DiscovIR-GCTM (GC-FTIR)            DiscovIR-LCTM (LC-FTIR)
                      real-time, vapor to solid phase     real-time, solvent removal
DiscovIR Software &
  Data Processing




   Dell Desktop Computer
   Thermo-GRAMS /32
   Software Package
    • Library Search & Creation
    • Ratio Chromatograms
    • CFR 21-Part 11 Compliant
Direct Deposition FTIR
  & Data Processing
How Does It Work?
How is the Solvent Removed?
                                 N2 Addition
                                                 Cyclone
From LC                           Cyclone        Evaporator
                                 Evaporator
          Thermal Nebulization



                                 Air Cooled
                                 Condenser

                                                 Patent pending:
                                                 PCT/US2007/025207

                                  Chilled
                                 Condenser




                                                         Particle Stream to DiscovIR




                                 Waste Solvent
ZnSe Sample Disk



Auto sampler compatible

Unattended overnight runs

The ZnSe sample disk (yellow)
is under vacuum without
moisture or CO2 interference

Re-usable after solvent
cleaning

Transmission IR analysis is
done on the solid deposit.
DiscovIR Components

                                         IR Detector
                                               Interferometer   PCB
                         Cryogenic LN2




                                                 ABB Bomem
                                         M
                                         C
                                         T
Sample deposit 
ZnSe window




   Vacuum 
   chamber

Precision Vacuum Back 
plate                     Optical path
Direct Deposition IR in Action




                            13
What is Direct Deposition FTIR?
GPC-IR Hyphenated Technology
      3-dimensional Plot




                         15
Features of DiscovIR-LC


High Quality Solid Phase Transmission IR Spectra

Real-Time On-line Detection

Microgram Sensitivity

Compatible with all LC Solvents and Gradients

• e.g. Water, ACN, Methanol, THF, Chloroform, HFIP

Compatible with all GPC/SEC Solvents

Fully Automated Operation: No Fractionation

Multi-Sample Processing: 10 Hr ZnSe Disk Time
Applications


Applications of DiscovIR-LC for Excipient Analysis

• Excipient Characterization: Copovidone PVP/VAc

• Excipient Degradation from HME Process: HPMCAS

• Forced Degradation Analysis: PEG

• De-Formulation of Polymers and Additives

   (Macromolecules + Small Molecules)



Q&A


                                                     17
IR Spectrum of Copovidone
                Excipient - VP/VAc Copolymer


Peak 1680 cm-1 from VP comonomer

Peak 1740 cm-1 from VAc comonomer
Excipient Compositional Drift
                                   w/ MWD Vs. Bulk Average
          GPC-IR Chromatogram Overlay with Comonomer Ratios



        Copovidone

        Bulk Average




                          (Molecular Weight Distribution)
Abs. Peak Ratio: AVA / AVP = (k1*b*MVA) / (k2*b*MVP) = k (MVA / MVP) ~ Comonomer Ratio
Excipient Compositional Drift
                                                 w/ MWD Vs. Bulk Average
                     .6


                                                                 Copovidone: sample A    50
                          molecular weight
                     .5




                                                                                         % acetate comonomer
                          distribution
max. IR absorbance




                                                                                         45
                     .4




                     .3   Bulk Average                           comonomer composition   40
                          40% VAc                                distribution
                     .2


                                                                                         35

                     .1




                      0                                                                  30




                             106         105   104   103   102   Molecular Weight
Copovidone MW Distributions from
                                                   Different Suppliers (Manf. Processes)
                     .6

                          Copovidone: sample A
                                      sample B
                     .5
                                      sample C
max. IR absorbance




                     .4




                     .3




                     .2




                     .1




                      0




                                                                           Molecular Weight
                               106       105        104     103     102
                          Copovidone A gave clear tablets while Copovidone C led to cloudy ones.
Copovidone Compositional Drifts
                                                        from Different Manf. Processes
                     .6

                          Copovidone: sample A
                                                                                                  50
                                      sample B




                                                                                                  % acetate comonomer
                     .5
                                      sample C
                                                                                                  45
                     .4
                            Molecular Weight
                                                                          Comonomer Composition
max. IR absorbance




                            Distribution
                     .3
                                                                          Distribution
                                                                                                  40

                                                                             Bulk 40% VAc
                     .2


                                                                                                  35

                     .1




                      0                                                                           30




                               106       105         104      103   102
                                                 Molecular Weight
Excipient Characterization
                                           by LC-IR

Copolymer Compositional Analysis with MW Distributions

 • Comonomer Ratio Drift (Functional Groups) vs. Bulk Average

 • Excipient Lot-to-Lot Variations: QbD Studies

Excipient Performance & Functional Group Correlations

 • Hydrophobic/Hydrophilic Ratio Drift vs. Phase Separations

 • Effects on Excipient Dissolution Behavior



Reference
 (1) Chemical Heterogeneity on Dissolution of HPMC,
     EU J. of Pharma Sci., P392 (2009), A. Viriden et al.
 (2) Comp Drift Effect on Dissolution of PMMA/MAA,
     Materials Letters, P1144 (2009), E. Manias et al.
                                                                23
Excipient Degradation from HME
                                      Process

Hot Melt Extrusion Process: To Make Solid Dispersions
for Low Solubility Drugs to Improve Bioavailability

Degradation Issues
 • Excipient & API Degradation at High Temp. (100-200C)
 • Discoloration / Residues
 • Degradant / API Interactions

Process Variables
 • Temperature
 • Time
 • Screw Speed (Torque)
 • Screw Design
                                                          24
Excipient HPMCAS Degradation
 in Hot Melt Extrusion Process
Degradant from HPMCAS
              in Hot Melt Extrusion Process




IR Database Search Result: Succinic Acid
HPMCAS Degradation
                         in Hot Melt Extrusion Process




Functional Group Ratio Changes from High Temp Process (Sample C)
Degradation of HPMC-AS in
                              Hot Melt Extrusion Process
    Detected Degradant: Succinic Acid
    Detected Functionality Ratio Change: Hydroxyl Vs. Carbonyl
    Help Understand Excipient Degradation Mechanism
    Study Excipient / API Interactions
    Define Process Window: QbD




Fig. A Schematic Structure of HPMC Derivatives, Cellulose Ethers & Esters
Forced Degradation Study of
                                 Excipient PEG
PEG-1000 at 55C Air Bubbling Overnight; Reverse-Phase HPLC: H2O / ACN
IR Spectrum from
                        Main PEG Peak



Oxidation bands in bulk material seen at
               1720 and 1645
HPLC-IR of Std PEG-1000

AU Scale for all traces


                            1116 cm-1 band chromatogram


                            1607 cm-1 band chromatogram


                            1719 cm-1 band chromatogram




                                                          Minutes
HPLC-IR for
                               Degraded PEG-1000


Three Chromatographic displays
generated from one time ordered set of
FTIR Spectra
IR Identification of
                       Degraded Products




                              Na+ or K+ Cation
                Aldehyde      Carboxylate Salt
                  1719             1607

11.45 minutes


4.93 minutes

1.50 minutes
Proposed Mechanism of PEG Oxidation
     Supported by HPLC-IR Data
GPC-IR Analysis for Macromolecules and
                                 Small Molecules in the Same Run



          Macromolecules                                Small Molecules
           Polymers                                      Additives
           Excipients                                    Impurities
                                                         Degradants
                                                         or API’s




                             (Molecular Weight Distribution)
Polymer Additive Analysis Data with GPC-IR for ABS Plastic w/o Extraction Step:
IR chromatogram and ratio plot for ABS sample. Ratio (green) of characteristic IR
absorbance bands for nitrile (2240 cm-1) and styrene (1495 cm-1).
Polymer Additive Analysis with
                                   GPC-IR for ABS Plastic w/o Extraction Step




IR spectra at different elution times across the low MW peak of the SEC analysis of ABS. Spectra
                              indicate presence of multiple components.
Common Polymeric Excipients

Neutral Cellulose Derivatives
 • HydroxyPropyl Methoxy Cellulose (Hypromellose): HPMC
 • HydroxyPropyl Cellulose: HPC
 • Cellulose Acetate Butyrate: CAB
Acidic Cellulose Derivatives
 • HPMC Acetate Succinate: HPMC-AS
 • HPMC Phthalate: HPMC-P
 • Cellulose Acetate Phthalate: C-A-P
Copovidone: PolyVinyl Pyrrolidone / Vinyl Acetate – PVP/VAc

SoluPlus Terpolymer: PEG / PCL / PVAc

Methacrylate Copolymers: Eudragit

Polyethylene Oxide: PEO (MW > 20K) or PEG (MW < 20K)

Excipient Combinations with Plasticizers and Additives
                                                              37
LC-IR Applications in Excipient
                            Supply Chain and Formulations

  Excipient                Formulation               Formulated Drugs
  Manufacturing            Develop. & Manf.          Shelf Life Stability

         • Process           • Incoming QC              • Stressed
           Control           • Excipient                  Degradation
         • Lot-to-lot          Functionality
           Variations        • Formulation              • De-Formulate
         • CoA                 Development                Excipient
                             • QbD                        Blends
         • Novel
           Excipient R&D     • Process (HME)            • Trouble-Shoot
                               Degradation                Problem Drugs
                             • Define Safe                in the Market
                               Process Window
                             • Process
                               Monitoring




Users:    Excipient             Pharma Co.                 Pharma Co.
         Manufacturers       HME Service Providers       Generic Drug Co.
Excipient QbD Space

Slide from USP International Excipient Workshop (July 2009)
Excipient QbD Space

Slide from USP International Excipient Workshop (July 2009)




                                                       GPC
Excipient QbD Space
                            GPC-IR-Performance
Slide from USP International Excipient Workshop (July 2009)




                                                       GPC



                            IR
Excipient QbD Space
                             GPC-IR-Performance
 Slide from USP International Excipient Workshop (July 2009)




Performance




                                                        GPC



                             IR
THANK YOU !
 A NEW WORKHORSE TECHNOLOGY – DIRECT
DEPOSITION, SOLID PHASE, FULLY AUTOMATED
                   LC-IR
                Now formulation chemists can
                characterize excipient
                macromolecules with
                more accurate
                composition
                information


                                 Contact
                              Gerrit Blok
                            Sales Representative
                                 Mid-Atlantic
                               (717) 368-0549
                        blokg@spectra-analysis.com

               Learn more………..
                                                     43
  WWW.SPECTRA-ANALYSIS.COM
LC-IR Applications
Excipient Characterization, Functionality & Degradation Analysis

Copolymer Compositional Analysis across MW Distribution

Polyolefin Copolymer Branching Analysis by High Temp GPC-IR

Polymer Blend Ratio Analysis across MW Distribution

Polymer Additive & Impurity Analysis

De-Formulation for Polymers and Additives: Competitive Analysis

Process Control & Optimization

Excipients, Plastics, Rubbers, Films, Fibers, Foams & Composites

Reactive Polymer Analysis for Coating, Adhesive, Sealant & Elastomer

Isomer Analysis for Chemicals, Forensics & Pharmaceuticals

General Analytical Capability: Trouble Shooting
                                                                   44

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LC-IR Hyphenated Technology For Excipient Analysis-FDA USP Seminars-1-13-2010

  • 1. LC-IR Hyphenated Technology for Excipient Analysis FDA on Jan. 12, 2010 USP on Jan. 13, 2010 George Giansanti, Tom Kearney Gerrit Blok, Ming Zhou Spectra Analysis, Inc. 1
  • 2. OUTLINE Introduction: Company & LC-IR Technology DiscovIR-LC System: Instrumentation & Features Applications of LC-IR: Case Studies Q&A 2
  • 3. The Company 257 Simarano Drive Marlborough, MA 01752 Completed product engineering with patent protected ‘breakthrough’ technology during 2005 & 2006. Initiated sales and began building a ‘top tier’ customer base, 2007 thru 2009. Received R&D Magazine’s ‘Top 100’ product Award, 2008. Received Massachusetts Life Science Center, Certification & Award, 2009. Spectra has great people, ‘breakthrough’ products, huge market and is positioned for explosive growth ! December 2009 3
  • 4. Meet the Spectra Team George Giansanti William W. Carson, PE Ming Zhou, PhD. Tom Kearney, MBA President & CEO Sr. VP Engineering Applications Engrg. Mgr. Technical Sales Mgr. Cal Poly MIT Univ. Connecticut Univ. Vermont Sidney Bourne, PhD. Andrew Chung David Dunn Stacy Follo Sr. VP & Chief Scientist Product Engineer Sr. Applications Chemist Southeast Sales Rep. Univ. Wisconsin Northeastern Northeastern Northeastern Part time support: Lisa Velardo, CPA – CFO Gerrit Blok Mid-Atlantic Sales Rep. Cheryl McCarthy – Accountant Broek Institute, Amy Guyton – Materials & Logistics Amsterdam James Dwyer, PhD. – Technical Advisor
  • 5. DiscovIR Users Merck Pharma Johnson & Johnson Pharma Novartis Pharma Shire Pharmaceuticals Pharma Du Pont Polymers Dow Chemical Polymers Lawrence Livermore National Lab Trace Analysis Oak Ridge National Laboratory Environmental Naval Research Laboratory Organics US Army Aberdeen Proving Ground Forensics Pennsylvania State Police Forensics Alabama Department of Forensics Forensics Vermont State Police Forensic lab Forensics
  • 6. DiscovIR Product Line Separate→Concentrate→Identify DiscovIR-GCTM DiscovIR-LCTM 2008 Award Winner Applications: Applications: General Analytical Capability Excipients Forensic Labs Polymers (Controlled Substance Analysis) Advanced Materials DiscovIR-GCTM (GC-FTIR) DiscovIR-LCTM (LC-FTIR) real-time, vapor to solid phase real-time, solvent removal
  • 7. DiscovIR Software & Data Processing Dell Desktop Computer Thermo-GRAMS /32 Software Package • Library Search & Creation • Ratio Chromatograms • CFR 21-Part 11 Compliant
  • 8. Direct Deposition FTIR & Data Processing
  • 9. How Does It Work?
  • 10. How is the Solvent Removed? N2 Addition Cyclone From LC Cyclone Evaporator Evaporator Thermal Nebulization Air Cooled Condenser Patent pending: PCT/US2007/025207 Chilled Condenser Particle Stream to DiscovIR Waste Solvent
  • 11. ZnSe Sample Disk Auto sampler compatible Unattended overnight runs The ZnSe sample disk (yellow) is under vacuum without moisture or CO2 interference Re-usable after solvent cleaning Transmission IR analysis is done on the solid deposit.
  • 12. DiscovIR Components IR Detector Interferometer PCB Cryogenic LN2 ABB Bomem M C T Sample deposit  ZnSe window Vacuum  chamber Precision Vacuum Back  plate Optical path
  • 13. Direct Deposition IR in Action 13
  • 14. What is Direct Deposition FTIR?
  • 15. GPC-IR Hyphenated Technology 3-dimensional Plot 15
  • 16. Features of DiscovIR-LC High Quality Solid Phase Transmission IR Spectra Real-Time On-line Detection Microgram Sensitivity Compatible with all LC Solvents and Gradients • e.g. Water, ACN, Methanol, THF, Chloroform, HFIP Compatible with all GPC/SEC Solvents Fully Automated Operation: No Fractionation Multi-Sample Processing: 10 Hr ZnSe Disk Time
  • 17. Applications Applications of DiscovIR-LC for Excipient Analysis • Excipient Characterization: Copovidone PVP/VAc • Excipient Degradation from HME Process: HPMCAS • Forced Degradation Analysis: PEG • De-Formulation of Polymers and Additives (Macromolecules + Small Molecules) Q&A 17
  • 18. IR Spectrum of Copovidone Excipient - VP/VAc Copolymer Peak 1680 cm-1 from VP comonomer Peak 1740 cm-1 from VAc comonomer
  • 19. Excipient Compositional Drift w/ MWD Vs. Bulk Average GPC-IR Chromatogram Overlay with Comonomer Ratios Copovidone Bulk Average (Molecular Weight Distribution) Abs. Peak Ratio: AVA / AVP = (k1*b*MVA) / (k2*b*MVP) = k (MVA / MVP) ~ Comonomer Ratio
  • 20. Excipient Compositional Drift w/ MWD Vs. Bulk Average .6 Copovidone: sample A 50 molecular weight .5 % acetate comonomer distribution max. IR absorbance 45 .4 .3 Bulk Average comonomer composition 40 40% VAc distribution .2 35 .1 0 30 106 105 104 103 102 Molecular Weight
  • 21. Copovidone MW Distributions from Different Suppliers (Manf. Processes) .6 Copovidone: sample A sample B .5 sample C max. IR absorbance .4 .3 .2 .1 0 Molecular Weight 106 105 104 103 102 Copovidone A gave clear tablets while Copovidone C led to cloudy ones.
  • 22. Copovidone Compositional Drifts from Different Manf. Processes .6 Copovidone: sample A 50 sample B % acetate comonomer .5 sample C 45 .4 Molecular Weight Comonomer Composition max. IR absorbance Distribution .3 Distribution 40 Bulk 40% VAc .2 35 .1 0 30 106 105 104 103 102 Molecular Weight
  • 23. Excipient Characterization by LC-IR Copolymer Compositional Analysis with MW Distributions • Comonomer Ratio Drift (Functional Groups) vs. Bulk Average • Excipient Lot-to-Lot Variations: QbD Studies Excipient Performance & Functional Group Correlations • Hydrophobic/Hydrophilic Ratio Drift vs. Phase Separations • Effects on Excipient Dissolution Behavior Reference (1) Chemical Heterogeneity on Dissolution of HPMC, EU J. of Pharma Sci., P392 (2009), A. Viriden et al. (2) Comp Drift Effect on Dissolution of PMMA/MAA, Materials Letters, P1144 (2009), E. Manias et al. 23
  • 24. Excipient Degradation from HME Process Hot Melt Extrusion Process: To Make Solid Dispersions for Low Solubility Drugs to Improve Bioavailability Degradation Issues • Excipient & API Degradation at High Temp. (100-200C) • Discoloration / Residues • Degradant / API Interactions Process Variables • Temperature • Time • Screw Speed (Torque) • Screw Design 24
  • 25. Excipient HPMCAS Degradation in Hot Melt Extrusion Process
  • 26. Degradant from HPMCAS in Hot Melt Extrusion Process IR Database Search Result: Succinic Acid
  • 27. HPMCAS Degradation in Hot Melt Extrusion Process Functional Group Ratio Changes from High Temp Process (Sample C)
  • 28. Degradation of HPMC-AS in Hot Melt Extrusion Process Detected Degradant: Succinic Acid Detected Functionality Ratio Change: Hydroxyl Vs. Carbonyl Help Understand Excipient Degradation Mechanism Study Excipient / API Interactions Define Process Window: QbD Fig. A Schematic Structure of HPMC Derivatives, Cellulose Ethers & Esters
  • 29. Forced Degradation Study of Excipient PEG PEG-1000 at 55C Air Bubbling Overnight; Reverse-Phase HPLC: H2O / ACN
  • 30. IR Spectrum from Main PEG Peak Oxidation bands in bulk material seen at 1720 and 1645
  • 31. HPLC-IR of Std PEG-1000 AU Scale for all traces 1116 cm-1 band chromatogram 1607 cm-1 band chromatogram 1719 cm-1 band chromatogram Minutes
  • 32. HPLC-IR for Degraded PEG-1000 Three Chromatographic displays generated from one time ordered set of FTIR Spectra
  • 33. IR Identification of Degraded Products Na+ or K+ Cation Aldehyde Carboxylate Salt 1719 1607 11.45 minutes 4.93 minutes 1.50 minutes
  • 34. Proposed Mechanism of PEG Oxidation Supported by HPLC-IR Data
  • 35. GPC-IR Analysis for Macromolecules and Small Molecules in the Same Run Macromolecules Small Molecules Polymers Additives Excipients Impurities Degradants or API’s (Molecular Weight Distribution) Polymer Additive Analysis Data with GPC-IR for ABS Plastic w/o Extraction Step: IR chromatogram and ratio plot for ABS sample. Ratio (green) of characteristic IR absorbance bands for nitrile (2240 cm-1) and styrene (1495 cm-1).
  • 36. Polymer Additive Analysis with GPC-IR for ABS Plastic w/o Extraction Step IR spectra at different elution times across the low MW peak of the SEC analysis of ABS. Spectra indicate presence of multiple components.
  • 37. Common Polymeric Excipients Neutral Cellulose Derivatives • HydroxyPropyl Methoxy Cellulose (Hypromellose): HPMC • HydroxyPropyl Cellulose: HPC • Cellulose Acetate Butyrate: CAB Acidic Cellulose Derivatives • HPMC Acetate Succinate: HPMC-AS • HPMC Phthalate: HPMC-P • Cellulose Acetate Phthalate: C-A-P Copovidone: PolyVinyl Pyrrolidone / Vinyl Acetate – PVP/VAc SoluPlus Terpolymer: PEG / PCL / PVAc Methacrylate Copolymers: Eudragit Polyethylene Oxide: PEO (MW > 20K) or PEG (MW < 20K) Excipient Combinations with Plasticizers and Additives 37
  • 38. LC-IR Applications in Excipient Supply Chain and Formulations Excipient Formulation Formulated Drugs Manufacturing Develop. & Manf. Shelf Life Stability • Process • Incoming QC • Stressed Control • Excipient Degradation • Lot-to-lot Functionality Variations • Formulation • De-Formulate • CoA Development Excipient • QbD Blends • Novel Excipient R&D • Process (HME) • Trouble-Shoot Degradation Problem Drugs • Define Safe in the Market Process Window • Process Monitoring Users: Excipient Pharma Co. Pharma Co. Manufacturers HME Service Providers Generic Drug Co.
  • 39. Excipient QbD Space Slide from USP International Excipient Workshop (July 2009)
  • 40. Excipient QbD Space Slide from USP International Excipient Workshop (July 2009) GPC
  • 41. Excipient QbD Space GPC-IR-Performance Slide from USP International Excipient Workshop (July 2009) GPC IR
  • 42. Excipient QbD Space GPC-IR-Performance Slide from USP International Excipient Workshop (July 2009) Performance GPC IR
  • 43. THANK YOU ! A NEW WORKHORSE TECHNOLOGY – DIRECT DEPOSITION, SOLID PHASE, FULLY AUTOMATED LC-IR Now formulation chemists can characterize excipient macromolecules with more accurate composition information Contact Gerrit Blok Sales Representative Mid-Atlantic (717) 368-0549 blokg@spectra-analysis.com Learn more……….. 43 WWW.SPECTRA-ANALYSIS.COM
  • 44. LC-IR Applications Excipient Characterization, Functionality & Degradation Analysis Copolymer Compositional Analysis across MW Distribution Polyolefin Copolymer Branching Analysis by High Temp GPC-IR Polymer Blend Ratio Analysis across MW Distribution Polymer Additive & Impurity Analysis De-Formulation for Polymers and Additives: Competitive Analysis Process Control & Optimization Excipients, Plastics, Rubbers, Films, Fibers, Foams & Composites Reactive Polymer Analysis for Coating, Adhesive, Sealant & Elastomer Isomer Analysis for Chemicals, Forensics & Pharmaceuticals General Analytical Capability: Trouble Shooting 44