Quality Control Services
Analytical Testing
- Testing and Release of Raw Materials
- In-process and release testing of intermediates, drug substances, and drug product
- Final Product Testing and Release
- Stability Testing Support
HPLC Systems:
- Two Agilent 1200 Systems
- Two Waters Acquity Arc Systems
- Waters Alliance System
High Performance Liquid Chromatography including:
- Photo Diode Array Detection-UV/VIS/Dual Wavelength
- Ultra High Performance Liquid Chromatography (HPLC)
- QDa – mass detector
General Chemistry
- Karl Fischer Moisture (colurmetric)
- Fourier Transform Infrared Spectroscopy
- Ultraviolet/Visible Spectroscopy
- pH
- Specific Gravity
- Osmolality
- Conductivity
- Compendia USP/EP testing
- Viscosity
- Titrimetry
- Classical Wet Chemistry
- Particle size and Distribution
Microbiology
- Bacterial Endotoxin (USP <85>)
- Tests for Specified Organisms (USP <62>)
- Microbial Enumeration (USP <61>)
- Growth Promotion
- Antimicrobial Effectiveness Testing (USP <51>)
- Finished Product and Stability Test Support
Stability
With a 375 ft2 dedicated stability room, our team works with clients for all aspects surrounding stability from study development to program management.
ICH Qualified Storage Conditions:
- 5 ± 3 °C
- 25 ± 2 °C, 60 ± 5% RH
- 30 ± 2 °C, 65 ± 5% RH
- 40 ± 2 °C, 75 ± 5% RH