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