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Service Description
We offer a full range of stability testing services to assess the shelf-life, performance, and safety of products under various environmental conditions. Our studies are suitable for small molecules, biologics, large molecules, and medical devices. Each study is conducted according to a tailored protocol and documented with detailed reports at every stage. Types of studies available: Accelerated Stability – Predict long-term behavior in a short timeframe by exposing products to elevated stress conditions. Ongoing Stability – Monitor real-time product behavior throughout its shelf-life. In-Use Stability – Determine stability under actual usage conditions after packaging is opened or reconstituted. Photostability – Evaluate product degradation when exposed to light, according to ICH guidelines. Available storage conditions: 5°C ± 3°C -20°C ± 5°C -80°C ± 10°C 25°C ± 2°C / 60% ± 5% RH 30°C ± 2°C / 65% ± 5% RH 40°C ± 2°C / 75% ± 5% RH Support included: Stability Protocols – Custom-designed protocols approved and amended by the client. Stability Reports – Issued at each timepoint, detailing test conditions, deviations, and results.