At Abiozen, our stability studies are designed to ensure that pharmaceutical products maintain their quality, safety, and efficacy throughout their shelf life. By simulating real-world and accelerated storage conditions, we generate robust data that supports regulatory submissions and helps our partners bring stable, market-ready products to global markets.

Long-Term and Accelerated Stability Testing

We conduct both long-term and accelerated stability studies to evaluate product performance over time. Long-term testing replicates typical storage environments, while accelerated testing simulates extreme conditions such as elevated temperature and humidity to stress the formulation. This dual approach allows us to build a comprehensive stability profile and predict shelf life accurately, even for complex or sensitive compounds.

Storage Under ICH Conditions

Our stability chambers are precisely calibrated to International Council for Harmonisation (ICH) standards to ensure globally accepted data. The conditions include 25°C/60% RH for long-term studies, 30°C/65% RH for intermediate conditions, and 40°C/75% RH for accelerated testing. These controlled environments are essential for generating consistent, reproducible results that are accepted by regulatory agencies worldwide.

Photostability and Forced Degradation Studies

To further evaluate product robustness, we perform photostability studies that examine the effects of light exposure on formulations, especially those that are light-sensitive. Additionally, forced degradation testing is conducted to intentionally stress samples and identify potential degradation pathways. These studies enhance our understanding of impurity profiles and inform risk-based stability strategies.

Industry Alignment

Abiozen draws upon best practices from global leaders such as Thermo Fisher CRDMO and Curia Global, adopting their meticulous approach to ICH-compliant stability programs. Our infrastructure and expertise allow us to support a wide range of dosage forms and formulation complexities, delivering data you can trust for lifecycle management and regulatory approval.