Stability studies
At RS-LAB, we understand that stability is fundamental to the safety, efficacy, and shelf life of pharmaceutical products. Our Stability Studies service is designed to help you generate the reliable data required for regulatory submission, product labeling, and long-term quality assurance.
We conduct ICH-compliant long-term, accelerated, stress condition studies, and climate zone storage all tailored to your product’s unique characteristics and storage needs. With environmental chambers monitored around the clock and rigorous data documentation, we ensure precise control over every test parameter.
Whether you are launching a new formulation, modifying packaging, or expanding to new markets, our stability programs provide the scientific foundation you need to make informed decisions with confidence.
Core elements
- Accelerated Stability Studies: Rapid evaluation of product stability under elevated temperature and humidity conditions to simulate the effects of time. This approach supports faster decision-making during product development and helps predict shelf life early in the lifecycle.
- Real-Time Stability Studies: Long-term monitoring of product stability under standard storage conditions to assess its performance throughout the intended shelf life. These studies are essential for ensuring sustained product quality, efficacy, and compliance with regulatory standards.
- Climate Zone Storage: Secure, monitored storage in controlled environments that reflect various ICH climatic zones. Customized temperature and humidity settings ensure that your product remains stable and compliant throughout storage, transportation, and distribution.
- Stress Condition Studies: Designed to evaluate the resilience of your product by exposing it to extreme environmental conditions such as high temperature, humidity, light, and oxidation. These studies help identify potential degradation pathways and support the development of robust formulations and packaging systems.
Benefits
- Regulatory Confidence: Ensure full alignment with global industry standards through our meticulous stability testing and controlled storage protocols, supporting smooth regulatory submissions and approvals.
- Proven Expertise: Leverage the knowledge of our experienced team and advanced laboratory capabilities to generate precise, reliable data that supports informed decision-making and robust product development.
- Cost-Effective Insight: Detecting stability issues early helps reduce development risks, minimize product loss, and avoid costly delays—saving both time and resources.
- Market Advantage: Strengthen your position in the market by validating the stability and quality of your products, building trust with regulators, partners, and customers alike.