Pharmaceutical Stability Testing
ICH-compliant storage and testing to determine shelf-life and ensure product integrity across global climate zones.
The Benchmark for Reliability
Stability testing is the evidence required to support a drug's commercial life. At BrownBiology Laboratory, we provide a full-service managed stability program following ICH Q1A(R2) guidelines.
Comprehensive Forced Degradation
To establish stability-indicating methods, we perform rigorous stress testing, including acidic/basic hydrolysis, oxidative stress, thermal degradation, and photostability (ICH Q1B).
Managed Storage
Redundant HVAC systems, 24/7 continuous monitoring, and emergency power backup for every chamber.
Real-time Pulls
Automated scheduling and sample retrieval for immediate testing at designated time points.
Regulatory Reporting
Our stability data is delivered in ready-to-use formats for IND, NDA, and ANDA submissions. We provide comprehensive data trending and shelf-life extrapolation using ICH Q1E statistical models.
Secure Your Product's Future
From pilot batches to commercial monitoring, our stability programs are designed for long-term peace of mind.