UV light, temperature, humidity have a strong influence on the quality of pharmaceutical products. The preparate can lose its efficacy through inaccurate storage conditions. In the pharmaceutical industry, API and medicines are tested under long-term conditions to determine shelf life.

ICH Q1B Guideline standardizes the photostability testing on new pharmaceutical drug substances and drug products. For laboratories developing or manufacturing pharmaceutical drug substances and drug products, a robust design of photostability testing process is essential to ensure performance reliability, product quality and regulatory compliance. Inadequate testing chamber which is not designed in compliance with ICH Q1B Guideline can result in time delays and high investment cost. Whether performing forced degradation or confirmatory research, the solution is a carefully designed photostability chamber which creates environmental test conditions comply with ICH Q1B Guideline.

Homogeneous irradiation of the specimens is one of the most important requirements of the photostability tests. To achieve this, all the specimens are placed at same distance from the light source and the inhomogeneous emission of light by florescent lamps is compensated with the help of special light and UV filter systems. ICH Guideline Q1B Option 2 stated the lighting arrangement in order to ensure photostability tests to be carried out in less than 125 hours (approx. 18000 lux at 25°C).

Areas of Application

  • Cosmetics
  • Pharmaceutical
  • Solar Energy
  • Wind Energy