Impurities in Drug Substances and Drug Products

Raphael Nudelman, Chemical & Computational Toxicology, Teva Pharmaceuticals, Netanya, Israel (raphael.nudelman@teva.co.il)

Impurities are inevitably present in drug substances and drug products. They can result from residual carryovers of the synthetic process or form as degradation products during formulation of the drug product or during storage of the drug substance or drug product. The toxicity of such impurities is of a concern to drug manufacturers as well as for regulators who have provided various guidelines to assist in the analysis and control of impurities. The presentation will describe these guidelines and provide practical examples for coping with challenges that the industry is faced with. 

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Abstract Reference & Short Personal Biography of Presenting Author

Raphael completed his Ph.D. in organic chemistry from the Weizmann Institute of Science in Israel, followed by postdoctoral positions in the US Air Force Research Lab in Aberdeen Proving Ground, Maryland USA and in Duke University Medical Center, North Carolina USA. He joined Teva Pharmaceutical Industries' Medicinal Chemistry department in 2003 and in 2010 he established the Chemical & Computational Toxicology group which he currently heads.