Stability Testing & Sample Storage
At Aptuit, the stability testing and sample storage options represent extensive, comprehensive programs that provide fully validated and continuously monitored storage environments for all ICH and WHO (including e.g. ASEAN countries) test conditions. In addition, we can provide analytical capabilities to evaluate the physical, chemical, and microbiological properties of solids, liquids, semisolids, and parenteral formulations.
We can also support study design and management of forced degradation studies to assess the “stability-indicating” power of the analytical methods under development for stability testing, statistical support for stability testing includes support in both sample management (i.e. statistical randomization sampling plans) and statistical evaluation of both long-term (i.e. in line to ICH guidelines) and accelerated (i.e. for both traditional Arrhenius temperature and newer temperature/humidity Accelerated Stability Assessment Program approaches) stability data.
All of our analytical equipment is qualified and calibrated with full documentation covering the IQ/OQ/PQs, as well as routine and non-routine maintenance. Our access to validated data handling networks allows us to compile and deliver data to our clients quickly and efficiently.
We can therfore provide the following integrated services in the stability field:
- Stability Protocol Design per ICH and for global registration
- Forced degradation studies protocol design and study management
- Stability study management with physical, chemical and microbiological testing of samples
- Evaluation and reporting of Stability Data
- IND/NDA/IMPD/MAA/CTA filable data tables and text comments
- Statistical evaluation of data
- Sample storage in fully mapped, qualified, and continuously monitored walk-in and reach-in chambers
Conditions for walk-in and reach-in chambers:
• 5°C/ ambient humidity • 30°C/75% RH
• 15°C/75% RH • 30°C/ambient humidity
• 25°C/40% RH • 40°C/ambient humidity
• 25°C/60% RH • 40°C/NMT 25%RH
• 25°C/75% RH • 40°C/75% RH
• 25°C/90% RH • 50°C/ambient humidity
• 30°C/35% RH • 60°C/ambient humidity
• 30°C/60% RH# • -20°C/ambient humidity
• 30°C/65% RH • -70°C/ambient humidity
• 30°C/70% RH • ICH Photostability Option 2
• Thermal cycle exposure