The manufacturing process of APIs is a multifaceted endeavor that requires meticulous planning, execution, and adherence to regulatory standards. From the initial stages of drug discovery to full-scale production and distribution, each step is integral to ensuring that the final API is safe, effective, and of the highest quality. As pharmaceutical needs evolve, so too do the manufacturing processes, highlighting the importance of innovation and efficiency in this critical industry.
For APIs, stability testing serves to assess how the chemical, physical, and biological characteristics of the ingredient change over time. Various factors can influence API stability, including temperature, moisture, light exposure, and the presence of catalytic substances. Testing is generally conducted according to guidelines established by regulatory bodies such as the International Council for Harmonisation (ICH).