We offer testing on a range of stability testing, including the most commonly used 5 ±3°C, 25°C/60%, 30°C/65%RH, and 40°C/75%RH. We conduct stability studies at all stages of product development. Krins will ensure that stability studies methodology comply with ICH, US-FDA, and Health Canada and other relevant regulatory requirements/recommendations.
Our Service Portfolio Includes:
- Stability Protocol Design and Execution
- Forced Degradation Studies Design and Execution
- Development and Validation of Stability Indicating Methods
- Long Term Stability Studies
- Intermediate Stability Studies
- Accelerated Stability Studies
- Photo-stability Studies
- Customized Conditional Stability Studies
- Formulation Evaluation Stability Studies
- Stability Testing for R&D Stages (IND, NDA, and ANDA)
- Commercial / Post-Market Stability Studies
- Transportation Stability Studies (Including Simulation Studies)
- Freeze/Thaw Studies
- Customized Data Recording and Reporting
- OOT and OOS Trending Reports
- Stability Studies Summary Report Preparation
| Case | Study | Conditions |
|---|---|---|
| General | Long term2
Intermediate 2 Accelerated |
25 °C ± 2 °C/60% RH ± 5% RH; or 30 °C ± 2 °C/65% RH ± 5% RH; 30 °C ± 2 °C/65% RH ± 5% RH 40 °C ± 2 °C/75% RH ± 5% RH |
| Stored in refrigerator |
Long term Intermediate |
5 °C ± 3 °C 25 °C ± 2 °C/60% RH ± 5% RH |
| Stored in freezer |
Long term | -20 °C ± 5 °C |