Stability studies
The stability issue is faced in all parts of product development. The storage capabilities at Bioglan are fully compliant with ICH guidelines.
We offer:
- Stability study design and monitoring according to ICH (International Conference on Harmonization) guidelines
- Accelerated stability studies during product development
- Stability testing of API (active pharmaceutical ingredient) and finished product
- Screening stability studies during product development
- Trend analysis and suggestion for expiry date
- Stability reports
- Generation of documentation for Clinical Trial Applications (CTA, EU)/New Drug Applications (NDA, USA)
Storage conditions
General case
Condition | Temperature | Humidity control |
Freezer | -20°C ± 5°C | - |
Refrigerator | 5°C ±3°C | - |
Long term | 25°C ± 2°C | 60% RH ± 5% RH |
Intermediate | 30°C ± 2°C | 65% RH ± 5% RH |
Accelerated | 40°C ± 2°C | 75% RH ± 5% RH |
Semi-permeable containers
Condition | Temperature | Humidity control |
Long term | 25°C ± 2°C | 40% RH ± 5% RH |
Intermediate | 30°C ± 2°C | 60% RH ± 5% RH |
Accelerated | 40°C ± 2°C | ≤ 25% RH |
