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