Ranitidine—Investigations into the Root Cause for the Presence of N-Nitroso-N,N-dimethylamine in Ranitidine Hydrochloride Drug Substances and Associated Drug Products

• DOI: 10.1021/acs.oprd.0c00462
• Publication Date: 2020-12-01T14:03:40Z
• Authors: Fiona J. King; Andrew D. Searle; Michael W. Urquhart
• Keywords: 03 medical and health sciences; 0302 clinical medicine; 3. Good health

The presence of low levels of N-nitroso-N,N-dimethylamine (NDMA) in ranitidine hydrochloride drug products has been reported by regulatory agencies. GlaxoSmithKline undertook a root cause analysis ...