Nitrosamine in Pharmaceutical Products? A Deep Dive into Risk Management by Ron Najafi, Ph.D.

Dr. Ron Najafi discusses the formation of nitrosamines in pharmaceutical products in the video. He explores three root cause analysis approaches: supply chain, process impurities, and stability issues. He highlights the emergence of nitrosamines in Ranitidine and Valsartan, emphasizing the significance of conducting risk analysis throughout the pharmaceutical development process. About Emery Pharma: Emery Pharma is deeply committed to advancing public health and exclusively focuses on projects that enhance the well-being of both individuals and the environment. As a comprehensive contract research laboratory, Emery Pharma provides extensive support across the entire spectrum of pharmaceutical development, covering small molecule drugs, biologics, biosimilars, gene therapy, botanicals, and more. Emery Pharma's array of premium services includes analytical and bioanalytical solutions, microbiology and cell biology services, drug and impurity characterization, and comprehensive R&D with cGMP/GLP support. The Emery Pharma team excels in customizing innovative solutions tailored to the unique requirements of each client. They seamlessly oversee the entire process, from initial drug discovery to thorough data analysis and insights generation. Their expertise allows them to tackle scientific challenges proactively, ensuring clients avoid unnecessary setbacks. Emery Pharma's accomplished chemists and biologists harness state-of-the-art technology, encompassing cutting-edge tools such as high-resolution mass spectrometry (Orbitrap), triple quad LC-MS/MS, GC-MS, preparative HPLC, and 400 MHz multinuclear NMR. For further details, please don't hesitate to reach out to Emery Pharma at [email protected] or explore their website at: https://emerypharma.com/