How Are Impurities Managed in Pharmaceutical Manufacturing?
Impurities in pharmaceuticals can arise from various sources, including raw materials, manufacturing processes, and degradation. Toxicologists assess the potential risks associated with these impurities and establish acceptable limits. Advanced analytical techniques, such as chromatography and mass spectrometry, are employed to detect and quantify impurities. Regulatory guidelines, such as ICH Q3A and Q3B, provide frameworks for impurity management to ensure drug safety.
