In addition to our comprehensive services regarding stability testing and storage, we offer the test for photostability according to guideline ICH Q1B "Stability Testing: Photostability Testing of New Drug Substances and Products".
Equipment, Methods, Procedures
- Finished pharmaceutical preparations
- Primary packed products
- Temperature and moisture-regulated photostability cabinet
- The endpoint detection is performed with calibrated sensors
- UV (300-400 nm): At least 100 Wh/m²
- VIS (400-800 nm): At least 1.2 million lx
- Analysis of the unexposed and the exposed sample
- Analysis of reference samples
- Determination the physical properties
- Detection and analysis of degradation products
The light intensity and temperature during the tests are measured on the surface of the sample.