With many years of experience and thousands of samples on current storage in custom built, walk-in storage rooms, Eurofins | 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
- 25°C / 60% RH
- 30°C / 65% RH
- 30°C / 75% RH
- 40°C / 75% RH
- Photostability chambers
- Customised storage conditions
- Cold chain transportation study (freeze-thaw cycles)
- Simulated transport stability study (transport storage with simulated loads)
Eurofins | Chemical Analysis is licensed to handle both CYTOTOXIC and S8/S9 drug substances and products.