Stability Storage & Testing
ICH-compliant stability storage and analytical testing supporting clinical development and global regulatory submissions.
Identifies degradation risks and confirms shelf life. ICH-compliant stability protocols across Zones I–IVb. Includes accelerated (40/75), long-term (25/60) and Intermediate (30/65) and photostability testing.
Supports
- ICH Q1
- FDA
- Global submissions
- Zones I–IVb
Capabilities
Stability Storage Conditions
ICH-Compliant
| No. | Condition | Use |
|---|---|---|
| 01 | 25°C / 60% RH | Long-term (25/60) |
| 02 | 30°C / 65% RH | Intermediate (30/65) |
| 03 | 40°C / 75% RH | Accelerated (40/75) |
| 04 | 2–8°C | Controlled conditions |
| 05 | −20°C | Frozen and ultra-low storage |
| 06 | −30°C | Frozen and ultra-low storage |
| 07 | −80°C | Frozen and ultra-low storage (biologics) |
| 08 | Photostability | Photostability testing |
Full compliance with FDA and ICH guidelines.
02
ICH Climatic Zones I–IVb
Global submissions
- ZoneI
- ZoneII
- ZoneIII
- ZoneIVa
- ZoneIVb
- ICH-compliant stability protocols across Zones I–IVb
- Mitigation across ICH climatic zones
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ICH Stability and Release Testing
ICH Q1 · FDA
- API and drug product release testing
- ICH-compliant stability studies (long-term, intermediate, accelerated)
- Method verification, transfer, and validation
- Comparative and trend analysis
- Regulatory-aligned reporting for FDA and global submissions
04
Stability Programs
Stability programs for small molecules, peptides, biologics, and medical devices.
- 01Small molecules
- 02Peptides
- 03Biologics
- 04Medical devices
- Stability study design, data generation, and reporting per ICH Q1
- Shelf-life determination and storage condition verification
- Stability Studies under ICH conditions, including low temperatures (-20C to -80C)
- Initial stability assessments
Quality · Compliance
Full compliance with FDA and ICH guidelines.
- FDA-registered lab*
- ICH Zones I–IVb
- Storage down to −80 °C
- Reporting per ICH Q1
- Comparative and trend analysis
- U.S.-based operations
*Analytical Lab