Under ICH Q1A guidelines, adopted by the FDA and EMA, stability testing is intended to demonstrate how the quality of a drug substance varies with time under a variety of environmental stresses. Stresses that are commonly used for stability testing include temperature, humidity, and light.
Stability testing is also used as a verification process for packaging and packaged goods. It can also establish a re-test period for active pharmaceutical ingredient or a shelf life for the medicinal product and recommended storage conditions.
Our Stability Testing Services
Our test laboratories provide stability testing for the medical, personal care and pharmaceutical industry. With years of experience performing stability testing service, we are available to test or store a wide range of products in specific temperature and/or humidity conditions.
Applications include, but are not limited to; stability testing, accelerated aging, packaging, life science, biomedical storage and research.
We are able to accommodate large products or large batches of products for stability testing in one of our walk-in test chambers.
Stability Testing Capabilities
||-20°C to 60°C, -4°C to 60°C
||10% to 95% RH