Genotoxic and non-genotoxic impurities in pharmaceuticals Current regulations, status and trend

摘要

Drug Substance (DS) process development and Drug Product (DP) formulation development are two major areas of the drug development process. Impurities/degradants can be generated in either of the processes, from DS degradation or DS-excipieni interaction. These impurities may be non-genotoxic or genotoxic in nature. Regardless, they are regulated by Food and Drug Administration (FDA)/ International Conference on Harmonization (ICH) guidelines. Routine impurity analysis in pharmaceuticals requires identification at levels of 0.05 percent to 0.2 percent depending on the daily dose. However, genotoxic impurities can be much harder to defect due to their presence at low ppm levels. This review concentrates on the regulations and analytical technologies used to detect and quantitate impurities (genotoxic and non-genotoxic} in pharmaceuticals.