Stability Testing & QC Release

EAG offers complete stability testing program management in support of IND, clinical, registration stability and post-marketing programs. We offer a secure, DEA-licensed stability suite that covers all ICH conditions, as well as photostability and custom conditions—with over 35,000 cubic feet of stability storage space (the equivalent of 10 53-foot tractor trailers.)

A fully validated Rees monitoring system, redundant chamber systems and 100% backup power supply ensures an optimally-controlled, fully compliant cGMP environment for QC testing and sample storage. Our QC chemists work closely with Quality Assurance to ensure rapid turnaround of accurate, QA-reviewed data.

Storage Conditions

  • 25 °C / 60% RH
  • 30 °C / 60% RH
  • 30 °C / 65% RH
  • 40 °C / 75% RH
  • -20 °C, 5 °C, 50 °C
  • Controlled Room Temperature
  • Specially-Requested Conditions
  • Photostability

Physical Testing

  • Color Determination
  • Container Closure Integrity
  • Deliverable Volume
  • Particle Size
  • Appearance
  • Loss on Drying
  • Disintegration
  • Melting Point
  • Boiling Point
  • Density
  • Friability
  • pH
  • Turbidity
  • Viscosity
  • Moisture
  • Osmolarity
  • Hardness
  • Particulates

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