N-Nitrosamines Impurities in Pharmaceuticals the Abrupt Challenges They Bring and Approaches to Tackle the Risk

Affiliations

• ¹ Merck & Co., Inc. 770 Sumneytown Pike WP78-110 West Point, PA 19486, United States.
• ² US Food and Drug Administration, Center for Drug Evaluation and Research, Office of Pharmaceutical Quality, Office of Testing and Research, 645 S Newstead Ave., St Louis, MO 63110, United States.
• ³ Merck Healthcare KGaA, Frankfurter Straße 250, 64293 Darmstadt, Germany.
• ⁴ Merck KGaA, Frankfurter Straße 250, 64293 Darmstadt, Germany. Electronic address: christoph.saal@merckgroup.com.