Stability Studies

Pharmaceutical stability testing is conducted to determine how the quality of API, drug substance or drug product varies with time under the influence of environmental factors such as temperature, humidity and light. These studies also help determine optimal storage conditions, product quality and expiration date(s). The ICH Guideline Q1A is the consensus document for performing stability studies. In addition to the traditional shelf-life stability studies, Avista Pharma routinely performs specialized studies designed for individual products, performance requirements, regions and study goals.

 

Avista Pharma is your one-stop Stability Testing Partner:

 

  • Over 3,000 square feet of stability space
    • Redundant storage locations for business continuity
    • Continuous electronic monitoring and backup power to prevent service interruptions
    • Over 25 validated chambers across 3 locations covering the following ICH Q1A recommended conditions:
      • 25°C ± 2°C / 60%RH ± 5%RH
      • 30°C ± 2°C / 65%RH ± 5%RH
      • 40°C ± 2°C / 75%RH ± 5%RH
      • 5°C ± 3°C
      • -20°C ± 5°C
      • -70°C ± 15°C
      • Custom conditions/validation available
  • Fully-compliant GMP analytical chemistry and microbiological labs
  • Specialized studies to accommodate multiple needs:
    • Custom temperature and humidity settings
    • Custom study duration
    • Varying container and lot sizes
    • Freeze/thaw or other temperature cycles
    • IV set/drug compatibility studies
    • API/container compatibility studies
    • Dose solution stability
    • Photostability studies
      • ICH Guideline Q1B conditions
        • Not less than 1.2 million lux hours
        • Not less than 200 watt hours
      • Custom conditions available