Nitrosamine impurities have been in the center of the stage of impurities in drug products for the past 3 years. Regulators and industry have been deliberating the methods for determining limits for this special class of mutagenic/carcinogenic impurities. Preliminary guidelines have been published by regulatory agencies, however, they lack guidance on how to set limits for API-related nitrosamines, also known as “Complex Nitrosamines”. My presentation will discuss the ongoing activities to come to a consensus between the regulatory agencies and the pharmaceutical industry on what is the adequate process to set acceptable intake limits for the complex nitrosamines.
Raphael has over 20 years of pharmaceutical industry experience. He has a Ph.D. in organic chemistry from the Weizmann Institute of Science in Israel, a post-doctorate at the US Air Force Research Lab in Aberdeen Proving Ground, Maryland, and another post-doctorate at Duke University Medical Center, North Carolina. In 2001 he joined a startup biotech company in Israel that performed rational drug design by molecular modeling, and in 2003 Raphael joined the Medicinal Chemistry department at Teva Pharmaceuticals. In 2010 he established the Chemical & Computational Toxicology group in Teva, which he headed until mid-2021. Raphael now holds the position of Senior Director Impurity Expert in the R&D Operations department. Raphael's main topics of expertise are impurity and excipient qualification in drug substances and drug products.