Stability storage

Stability storage and testing is a critical component in drug development. It is conducted to determine how the quality of drug substance or drug product varies with time under the influence of environmental factors such as temperature, humidity and light. Cambrex offers a variety of storage conditions with our walk-in and reach-in chambers that meet the ICH Q1A requirements. Our chambers are mapped and fully qualified and are equipped with continuous monitoring with an added security of reserve power.

In addition to traditional shelf-life stability studies, Cambrex routinely performs specialized studies such as freeze/thaw, compatibility, and photo stability studies. Our analytical experts can support your stability testing at all phases of development and we offer a seamless experience to the customer from sample receipt to the issuance of the report.

Cambrex is your one-stop Stability Testing Partner:

  • Redundant storage locations for business continuity across multiple sites
  • Continuous electronic monitoring and backup power to prevent service interruptions
  • Various GMP stability storage conditions:
    • 25°C ± 2°C / 60%RH ± 5%RH
    • 25°C ± 2°C / 40%RH ± 5%RH
    • 30°C ± 2°C / 65%RH ± 5%RH
    • 40°C ± 2°C / 75%RH ± 5%RH
    • 40°C ± 2°C / 25%RH ± 5%RH
    • 60°C ± 2°C
    • 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
    • Freeze/thaw or other temperature cycles
    • IV set/drug compatibility studies
    • API/container compatibility studies
    • Dose solution/In-use stability studies
    • Photo stability studies
      • ICH Guideline Q1B conditions
        • Not less than 1.2 million lux hours
        • Not less than 200 watt hours
      • Custom conditions available

Find out more

Explore safe, stable storage solutions with Cambrex. Get in touch with a member of our team today.

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