At its core, stability testing involves the systematic evaluation of how the quality of a product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light. The primary goals are to determine the expiration date and the appropriate storage conditions for APIs and FPPs. Conducting these tests is essential not only for regulatory compliance but also for the assurance of patient safety.
Another fascinating example is the application of small-molecule APIs in the treatment of infectious diseases. Malaria, for instance, has been a global health challenge, prompting the development of effective small-molecule drugs such as artemisinin and its derivatives. These APIs, derived from the sweet wormwood plant, have become vital in the malaria treatment arsenal, showcasing the importance of natural products in API development. Advanced synthesis techniques and drug formulation strategies have further enhanced these molecules' efficacy, leading to better patient adherence and outcomes.
examples of api in pharma
PQQ is a small quinone molecule that was first identified as a co-factor for certain enzymes. Recent research has shown that PQQ possesses antioxidant properties, which help protect cells from oxidative stress. It is involved in the regulation of multiple biological processes, including cell signaling, gene expression, and mitochondrial biogenesis—the process by which new mitochondria are formed. Mitochondria, often referred to as the powerhouses of the cell, are essential for energy production.