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Stability

With many years of experience and thousands of samples on current storage in custom built, walk-in storage rooms, Chemical Analysis has all the skills and capacity to handle all types of stability programmes.

  • Fully validated to ICH Q1A (R2) requirements and meet strict temperature, relative humidity and uniformity requirements.
  • Fully controlled with round the clock 24/7 monitoring and electronic alert system.
  • Backed-up with on-site power generators in the event of a power outage.
  • Complete stability storage and testing services
  • Storage only service with temperature loggers during transportation if required
  • Support in designing studies for real time, stress tests and photostability studies
  • Development and validation of stability indicating methods
  • Examination of stability relevant parameters
  • Storage, coordination and management of stability samples
  • Issuance of stability reports with previous time point results at every testing time point
  • Backup storage facility for customer’s in-house stability samples due to emergencies or just overflow of samples from customer's in-house stability programme
  • 2-8°C
  • 25°C / 60% RH
  • 30°C / 65% RH
  • 30°C / 75% RH
  • 40°C / 75% RH
  • Photostability chambers
  • Customised storage conditions
  • −70°C
  • −35°C
  • −20°C
  • Cold chain transportation study (freeze-thaw cycles)
  • Simulated transport stability study (transport storage with simulated loads)


Chemical Analysis is licensed to handle both CYTOTOXIC and S8/S9 drug substances and products.