Stability Studies: ICH Stability and Photostability Testing
- Long-term stability studies
- Accelerated and intermediate testing
- Photostability testing (ICH Q1B)
- Shelf-life determination
- Packaging and container studies
- Stress and forced degradation
Common ICH Stability Storage Conditions
| Study | Typical storage condition | Notes |
|---|---|---|
| Long-term | 25 °C / 60% RH or 30 °C / 65% RH; 30 °C / 75% RH for hot and very humid climates | The condition depends on the climatic zone of the intended market |
| Intermediate | 30 °C / 65% RH | Used when accelerated testing shows significant change |
| Accelerated | 40 °C / 75% RH | Typically six months |
| Refrigerated products | 5 °C ± 3 °C | Long-term condition for products stored in a refrigerator |
| Photostability (ICH Q1B) | At least 1.2 million lux hours of visible light and 200 W·h/m² of near-UV | Exposure for confirmatory photostability testing |
Percival RX Stability and Photostability Chambers
SCADA/LIMS connection
Running Reliable Stability Programmes
Map the chamber
Monitor continuously
Catalogues and Compliance Documents
Frequently Asked Questions
What is a stability chamber?
A chamber that holds a defined temperature and relative humidity for months or years, so products can be stored under ICH conditions and tested at set time points to establish shelf life and storage instructions.
Which ICH conditions do Percival RX chambers cover?
RX stability chambers control relative humidity up to 75% at 40 °C, covering common long-term, intermediate and accelerated conditions. The RX-3000 and RX-3600 run 2–44 °C ± 0.5 °C; the RX-3600E extends to 70 °C.
How does the RX-3000L meet ICH Q1B?
It exposes samples to LED light replicating visible sunlight (6500 K) at 52 klux and near-UV (UVA) at 40 W/m², meeting ICH Q1B Option 1 within a 24-hour cycle.
What chamber sizes are available?
The compact RX-3000 and RX-3000L (0.3 m³) and the RX-3600 and RX-3600E (0.8 m³).
Do you provide qualification documents?
Installation, operational and performance qualification documentation can be provided as an option for supported equipment. Ask when you request a quotation.
Who uses stability chambers?
Pharmaceutical, medical device and cosmetic manufacturers and the research and testing laboratories that support them.