288 страниц. 2012 год. LAP Lambert Academic Publishing The impurities in pharmaceuticals are unwanted chemicals that remain with the active pharmaceutical ingredients (APIs) or develop during formulation or upon aging of both API and formulation. The presence of these unwanted chemicals even in trace amount may influence the efficacy and safety of pharmaceutical product. The control of impurities is currently a critical issue to the pharmaceutical industry. International Conference on Harmonization (ICH) formulated guidelines regarding the control of impurities.