Stability studies
Comprehensive range of stability services across time zones
We help you design container closure systems, storage and transportation condition early in the drug development through formal and ICH compliant stability studies.
What we offer
- Development and validation of stability indicating methods
- Developmental stability programs
- cGMP registration stability programs
- Comprehensive and readymade stability reports for regulatory submission
How does it work?
We have an extensive capacity and range of conditions including climatic walk-in chambers, refrigerator & freezer storage, with fully controlled and monitored stability chambers. These have 100% power back-up and 24-hour alarm systems for any excursions. Our dedicated “on-call” teams too are available 24 x 7 x 365, to respond to any excursions.
The stability samples are analysed using Stability Indicating Analytical Methods (SIAM), to generate scientifically sound data and trend. The stability programs are monitored, and the final reports are reviewed and approved by our QA team.
Infrastructure
- Real time walk-in chambers from Newtronic and Mack with 18000 liters capacity
- Intermediate and Accelerated chambers from Thermo lab and Newtronics with 400 to 800 liter capacity
- Refrigerator (5°C ± 3°C) chambers from Thermo lab and Newtronics with 400 liter capacity.
- Freezer (-20°C ± 5°C, -30°C ± 5°C & -80°C ± 5°C ) chambers from Arctiko, Thermo lab and Newtronics with 1000 liter capacity
- Photo stability chamber from Newtronics
