Stability Studies

Stability studies are a pivotal element in drug development, spanning from early clinical trials to product registration. Possessing a comprehensive understanding of the stability of pharmaceutical substances and finished products is crucial for maintaining consistent quality throughout their shelf life.

At EMINENT’s Pharmaceutical Research Laboratory (PRL), we are equipped with state-of-the-art technology to carry out extensive pharmaceutical stability testing. This includes both accelerated (short-term) and long-term studies. Our stability storage chambers are meticulously mapped during their initial qualification and are subject to continuous scrutiny through a validated monitoring system. These studies follow rigorously developed and validated stability protocols, whether crafted by our laboratory analysts or provided by clients. Additionally, the tests evaluate the stability of drugs under various packaging conditions and closed system scenarios, taking into account their physical, chemical, microbiological, and toxicological properties.

The degradation profiles obtained from these stability tests are crucial. They help identify key factors affecting the stability of a drug product, such as temperature fluctuations, humidity, exposure to light, oxidation, and pH levels. Leveraging this data, we can make informed adjustments to manufacturing processes, formulation components, and packaging techniques, all aimed at enhancing the long-term stability of each drug product. Understanding these degradation profiles is invaluable, not only for accelerating the development of drug products but also for reducing the costs associated with their development.