Evaluating Light Sensitivity to Support Shelf Life and Labeling
Exposure to light can degrade pharmaceuticals and biologics, affecting safety, product quality, and shelf life. Demonstrating that a product is appropriately protected—or understanding how light affects its integrity—is a requirement for many regulatory filings.
BA Sciences designs and conducts ICH Q1B-compliant photostability studies for a wide range of drug products. We tailor protocols to dosage form, packaging configuration, and development phase, helping clients generate the data needed to support regulatory submission and shelf life claims.
Our Photostability Testing Services Include
- ICH Q1B Option 1 and Option 2 testing protocols
- Confirmatory and forced degradation studies
- Quantitative and qualitative evaluation of degradation products
- Support for both product development and regulatory submission
- Testing conducted in a Powers Scientific photostability chamber equipped with a Honeywell eZtrend® data recorder
- Light exposure per ICH Q1B Option 2 using a cool white fluorescent lamp (per ISO 10977) and a near UV fluorescent lamp with spectral distribution from 320 nm to 400 nm
Why Work with BA Sciences
We help pharmaceutical and biologics developers evaluate light-related degradation risks with precision and efficiency. Every project is supported by a dedicated manager and a multidisciplinary scientific team with decades of experience. Since 1987, we’ve served life sciences clients around the world with regulatory-aligned testing and responsive communication.
What we provide:
- Photostability studies aligned with ICH Q1B guidance
- Controlled lighting environments using dedicated stability chambers
- Integrated support for packaging compatibility and shelf life
- Clear timelines and documentation from start to finish
