Phenylbutyrate is a chemical compound used in the treatment of urea cycle disorders. However, the manufacturing process of phenylbutyrate may result in the presence of impurities that can affect its safety and efficacy. These impurities can include residual solvents, isomers, and other related compounds that must be identified and controlled to ensure product quality and patient safety. Analytical methods are used to detect and quantify these impurities, and regulatory agencies have established limits for their levels in pharmaceutical products.
