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 and Q1 Scientific’s stability storage and sample management capabilities serve the Pharmaceutical, Medical Device and Life Sciences industries, with locations across North America and Europe.  We offer a variety of storage conditions, with walk-in and reach-in chambers that meet the ICH Q1A requirements. Our chambers are mapped and fully-qualified for long-term and short-term shelf life studies under various temperature and humidity requirements. This includes intermediate testing and accelerated testing per ICH Q1A (R2).  Our facilities and chambers are equipped with continuous monitoring and 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, with Q1 Scientific, provides the following capabilities and conditions for stability storage and testing:

  • 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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