APIs are defined as chemical substances or compounds that are intended to be used in the formulation of a drug product. They can be derived from various sources, including natural extracts, synthetic chemicals, or biotechnological processes. The development and manufacturing of APIs involve a series of intricate steps, where each stage is critical to ensuring the quality, safety, and efficacy of the final pharmaceutical product.
Stability studies typically involve long-term, accelerated, and intermediate testing. Long-term studies provide information about the API’s stability under normal storage conditions, often conducted over a period of 12 months or more. Accelerated testing involves higher temperatures and humidity levels to expedite decomposition, allowing manufacturers to predict long-term stability in a shorter time frame. Intermediate testing often serves as a bridge, assessing stability under conditions that fall between long-term and accelerated studies.
Ensuring the microbiological quality of water is essential, especially in industries like food and beverage, pharmaceutical, and cooling water systems. Disinfectants such as chlorine, ozone, and ultraviolet light are commonly used to eliminate harmful microorganisms. Biocides are used to control biological growth in systems like cooling towers and membrane processes, preventing fouling and contamination.
