Pharmaceutical Stability Testing

Pharmaceutical stability testing is a critical component of drug development and quality assurance. Stability stydies for Pharmaceuticals determine how the quality, safety, and efficacy of a drug product change over time under environmental factors such as temperature, humidity, and light. Stability testing is essential not only for new drug products but also for reformulated or post-approval products, particularly after changes to the manufacturing process, formulation, or packaging system. These studies support shelf-life assignment, regulatory submissions, and overall product lifecycle management.

At QACS Labs, we provide GMP-compliant pharmaceutical stability testing following international standards and ICH guidelines. Our laboratory is equipped with state-of-the-art stability chambers that allow precise control and continuous monitoring of storage conditions, enabling accurate evaluation of product performance under long-term, intermediate, and accelerated conditions.

Our stability testing services include:

• Real-time stability studies to assess product performance throughout its intended shelf life

• Accelerated stability studies according to ICH or custom climatic zones

• Photostability testing in compliance with ICH Q1B guidelines

• Thermal stress and freeze–thaw cycle studies to evaluate product robustness under extreme conditions

• Post-approval and reformulation stability programs to ensure continued compliance and product integrity

Samples are carefully stored in validated stability chambers, and all analyses are conducted at the defined time points specified in your stability protocol. Our GMP-certified laboratories use validated analytical methods to ensure accuracy, reproducibility, and regulatory compliance. Analytical data is fully documented to support regulatory submissions, batch release, and shelf-life justification.

With over 20 years of experience in pharmaceutical quality control, our team of experts works closely with clients to design customized stability testing programs tailored to each product’s formulation, packaging, and intended market. By choosing QACS Lab, you ensure that your stability studies are comprehensive, reliable, and fully aligned with international regulatory expectations, providing the confidence needed to bring safe and effective pharmaceutical products to market.

For Pharmaceutical Testing solutions contact us –  [email protected] – +30 210 29 34745