Handbook of Isolation and Characterization of Impurities in Pharmaceuticals Michael V University of Paderborn

University of Paderborn

capacity and demand participation

What has happened to those technologies

* ISI impact factor of 4

Handbook of Isolation and Characterization of Impurities in Pharmaceuticals Michael V University of PaderbornThe United States Food and Drug Administration (FDA) and other regulatory bodies around the world require that impurities in drug substance and drug product levels recommended by the International Conference on Harmonisation (ICH) be isolated and characterized. Identifying process related impurities and degradation products also helps us to understand the production of impurities and assists in defining degradation mechanisms. When this process is