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Photostabilität

Photostability

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

We analyze
  • Drugs
  • Finished pharmaceutical preparations
  • Primary packed products
  • Cosmetics
Equipment
  • Temperature and moisture-regulated photostability cabinet
  • The endpoint detection is performed with calibrated sensors
Dose
  • UV (300-400 nm): At least 100 Wh/m²
  • VIS (400-800 nm): At least 1.2 million lx
Analysis
  • Analysis of the unexposed and the exposed sample
  • Analysis of reference samples
  • Determination the physical properties
  • Assay
  • Detection and analysis of degradation products
  • Dissolution

The light intensity and temperature during the tests are measured on the surface of the sample.

GBA PHARMA GMBH