Regulatory Compliance
We adhere to the ICH Q1B guideline, conducting photostability testing on a single batch of material to provide reliable data on how your drug substance or product reacts to light exposure. This helps you meet regulatory requirements and avoid compliance issues.
Proactive Quality Assurance
Whether performing forced degradation or confirmatory studies, data from our fully qualified, temperature and humidity-controlled photostability chambers helps you take proactive steps to ensure product quality.
Consistent Light Exposure
We expose your samples side-by-side to guarantee consistent light exposure, ensuring accurate and reliable results.
Precise Testing Duration
Samples are exposed for the precise duration required to meet ICH Q1B standards, including:
- Illumination of not less than 1.2 million lux hours (equivalent to 2 to 3 days’ exposure close to a sunny window in the summer).
- Integrated near UV energy (320 nm to 400 nm: UVA) of not less than 200 watt hours per square meter (equivalent to 1 to 2 days close to a sunny window).
Accurate Monitoring
We use calibrated radiometers and lux meters to monitor light exposure accurately, ensuring the integrity of your data.
Thermal Change Assessment
If specified, we place dark controls (wrapped in aluminium foil) alongside your samples to assess any thermally induced changes.
Detailed Reporting
We generate a detailed graph that confirms light exposure over time, providing you with clear and comprehensive data.
