While polyacrylamide is effective in various applications, its use is not without concerns. The primary issue revolves around the potential toxicity of acrylamide, a monomer that can be harmful if not completely polymerized. Ensuring the proper handling, use, and disposal of polyacrylamide is essential to minimize its impact on human health and the environment. Regulatory bodies have set guidelines to limit the concentration of unreacted acrylamide in products, and manufacturers need to comply with these regulations to ensure safety.
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.
API manufacturing can be broadly categorized into two methods chemical synthesis and biotechnological processes. Chemical synthesis involves the creation of APIs through chemical reactions, often requiring multiple steps to achieve the final product. This approach is well-established and can be scaled effectively, making it suitable for small-molecule drugs.