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.

What we offer

Our company provides comprehensive sample management and analysis services in the field of pharmaceutical and chemical research. As part of our services, we undertake the secure storage of samples in specialized stability chambers under controlled temperature and relative humidity conditions. Specifically, samples can be stored in chambers set at 25°C / 60% RH, 30°C / 65% RH, 30°C / 75% RH and 40°C / 75% RH, in accordance with international standards for stability studies.

Throughout the storage period, continuous monitoring and recording of environmental conditions are carried out, ensuring the reliability and traceability of the data.

QACS is also able to undertake the analysis of samples in addition to their storage. By performing evaluation or transfer of the relevant analytical method (verification and/or transfer), our company can carry out the determination of Assay, Related Substances, Dissolution Profile, a wide range of physicochemical analyses (water content, viscosity, hardness, etc.), as well as microbiological testing.

In addition to the ICH conditions mentioned above, the possibility of applying customized storage conditions is also provided upon communication with the client, in order to conduct studies under special or “exotic” conditions, such as 25°C / 40% RH, 30°C / 35% RH, 25°C / 75% RH, etc. Furthermore, the company offers the capability to perform photostability studies in accordance with ICH guidelines.

The analyses aim to evaluate the stability, quality, and physicochemical characteristics of the products, while the results are documented in detailed analytical reports provided to the client. In this way, compliance with the applicable regulatory standards is ensured, supporting product development and quality assurance.

Why choose QACS Lab

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