Accelerated Stability Testing
Dalton supports its customers' products with our in-house stability services including full stability services from protocol development for accelerated stability, intermediate term stability and long term stability programs. Data and trending analysis performed by Dalton's stability experts, means results you can rely on. We even offer stability testing programs for your controlled drug products (scheduled drugs).
Our modern laboratory and experienced analysts ensure your stability pulls are performed on time and that the high-quality test results are provided to you on schedule. We can compile and generate detailed stability reports that meet your reporting requirements for commercial products as well as programs designed to support your clinical programs.
All stability programs are maintained in qualified in-house stability chambers that are controlled and monitored 24/7 for any change in Temperature and Humidity and are fully supported with our alarm notification system and backup generator keeping your stability studies safe and secure.
Dalton offers a wide range of ICH compliant stability conditions including:
- 25°C ± 2°C / 60% RH ± 5% RH
- 30°C ± 2°C / 65% RH ± 5% RH
- 40°C ± 2°C / 75% RH ± 5% RH
- 5°C ± 3°C
- -20°C ± 5°C
- Photo-stability ICH Q1B: 14,000 Lux Vis and 200 W/m2 U
We offer a wide range of stability and analytical services:
- Protocol Development
- Development and Evaluation of Stability indicating methods
- Long-Term Stability Testing
- Intermediate Stability testing
- Accelerated Stability Testing
- Formulation Evaluation Stability Testing
- Forced Degradation Studies
- Data and trending analysis
- Controlled Drug Products Stability Testing
- Commercial Product Stability Testing
- Comparator Stability Testing
- Photostability
Let Dalton be your trusted partner for all of your stability and analytical testing needs.