| Photostability
Chamber
- Photostability chamber that satisfy both FDA and ICH guidelines.
- A state of the art photostability chambers are available.
- This chamber has the capability to provide fluorescent light intensities from 1,000 to 10,000 Lux hour.
- Samples stored at 10,000 Lux can satisfy the ICH guidelines for light exposure in as little as five days.
- The UV study is done simultaneously. Separate switches are provided for incandescent and UV light sources.
- Door switch for switch off the UV light when door is opened.
- Regular & GMP model.
- T emperature range : 5°C to 50°C, ± 0.5°C.
- Humidity range : 40% to 95% ± 2% RH.
- Illumination : 1.2 million Lux hours.
- UV light : UV-A, 200 watts hours/m2
- Capacity : 200 / 400 / 800 / 1000 Litres
Storage Conditions
5°C Refrigerated Condition.
25°C Ambient Humidity.
25°C / 60% R.H. Primary ICH Long Term Condition.
30°C Ambient Humidity.
30°C / 60% R.H. Intermediate ICH Condition.
40°C / 75% R.H. Accelerated ICH Condition.
Photostability... 1,000 to 10,000 Lux (ICH Option 2).
Sequential and simultaneous ageing test. In addition to the temperature and humidity ageing, the short period photo-ageing is separately carried out with extremely strong light having a defined lighting specifications or the simultaneous ageing with temperature, humidity and lighting in accordance with ICH guidelines.
The stability tests in accordance to the ICH guidelines CPMP/ICH/279/95 under constant temperature and humidity conditions and at the same time under the effect of light. |
