Full Service Analytical and Microbiological Lab

Areas of Expertise

• Compendia Testing According to CFR, USP, NF, EP, JP, AOAC and other standards
• Technical Transfer and Validation of Analytical Methods
• Microbiology
• In-Process Testing
• Biological Assays
• Finished Product Testing and Release
• Stability Study Development and Management Including Testing and Storage according to ICH guidelines

Analytical Chemistry Department
Chromatography

• High Performance Liquid Chromatography including:
  • Fluorescence Detection
  • Photo Diode Array Detection-UV/VIS
  • Refractive Index Detection
  • Evaporative Light Scattering Detection
  • Conductivity Detection
  • Ultra High Performance Liquid Chromatography (HPLC)
• Ion Chromatography
• Gas Chromatography including:
  • Flame Ionization Detection
  • Electron Capture Detection
  • Thermal Conductivity Detection
  • Headspace Analysis
  • Thin Layer Chromatography

Biological Assays

• Polyacrylamide Gel Electrophoresis (SDS-PAGE)
• Western Blotting
• Polyacrylamide Gel Isoelectric Focusing (PAG)
• Enzyme Linked Immunosorbant Assay (ELISA)
• Radial Immuno Diffusion (RID)

Protein Determination

• Lowry
• BCA
• Ninhydrin
• Kjeldhal Protein -- Protein Nitrogen Unit
• Coomassie

General Chemistry

• Karl Fischer Moisture
• Fourier Transform Infrared Spectroscopy
• Ultraviolet/Visible Spectroscopy
• Total Organic Carbon Analysis
• pH
• Specific Gravity
• Osmolality
• Conductivity
• Draeger Tube testing
• Optical Rotation
• Compendia USP/EP/JP testing
• Viscosity
• Titrimetry
• Classical Wet Chemistry

Stability Studies: Storage, Testing and Program Management
ICH Qualified Storage Conditions:
5° ± 3°C, Ambient Humidity
25° ± 2°C, 60 ± 5% RH
30° ± 2°C, 65 ± 5% RH
40° ± 2°C, 75 ± 5% RH

Microbiological Quality Assurance Department

• Bioburden Test Validation/Determination
• Bacterial Endotoxin (Gel Clot Method/Turbidimetric Method)
• USP Particulate Testing: HIAC/ROYCO and Microscopic
• Sterility Testing: Direct Inoculation or Membrane Filtration
• Bacteriostasis/Fungistasis Validation
• USP Microbial Limits Test
• USP Antimicrobial Perservative Effectiveness
• Bacterial and Fungal Identification
• Container/Closure Integrity Testing by Microbial Immersion