Navigating Nitrosamines – Back to Basics

Nitrosamines have been the compounds of interest for the pharmaceutical industry in recent years due to the mutagenic nature of these impurities. This all started with one nitrosamine impurity N-Nitroso dimethylamine (NDMA) and eventually the list expanded to many nitrosamines in various drug substances and drug products. 

More recently nitroso-drug substance-related impurities (NDSRI) became the major concern for the industry. As per regulations, any possibility for the formation of Nitroso impurity in the synthetic route or the manufacturing process of the drug substance must be evaluated, and steps must be taken to identify, quantify and minimize/eliminate such impurities. So, the presence of robust methods for the detection and quantitation of such impurities is the need of analytical laboratories. By attending this session, you will understand that the discussion will focus on helping companies getting started in their journey with nitrosamines. It will cover the steps companies need to take to ensure they have a sufficient nitrosamines risk assessment.

Presenter: Danita Broyles (Harmony Biosciences)

is a native of Clarksdale, MS. She received her B.S. in Chemistry from Rust College and a dual degree M.S. in Biomedical Engineering from the University of Memphis, and the University of TN-Memphis Health Science Center. Danita has an extensive career in the pharmaceutical industry where she tested and released raw materials, performed analytical method validations/transfers, and led compendial compliance and advocacy initiatives throughout her career. Danita is currently the Director of Quality Assurance – CAMS at Harmony Biosciences. She leads a group that specialized in all things Compendial, Analytical, Microbiology, Stability, and Special Project related at Harmony Biosciences. Danita is Co-Chairperson of the Mid-West Compendial Discussion Group, Treasurer of the New Jersey Pharmaceutical Quality Control Association, and she Co-Chairs the USP Stakeholder Engagement Planning Committee. Danita also serves on the USP’s Nominating Committee for the Council of Experts for the 2025-2030 cycle. Danita is a well sought after speaker who has presented a numerous conferences and events throughout her career.

Presenter: Chander Mani (Field Technical Specialist-LC Columns, Agilent Technologies, Inc.)

Mr. Chander Mani holds a Master’s degree in Chemistry and began his career at Panacea Biotec in the Analytical & Bioanalytical department of new drug discovery research. There, he specialized in method development for analytical and bioanalytical analysis, as well as ADME/DMPK-related studies. He later joined Bureau Veritas, where he developed multiple LC-MS-based methods for analyzing textiles and environmental analytes of interest. For over 12 years at Agilent, Chander has been actively involved in providing LC and LC-MS application support across pharmaceuticals, food safety, and environmental applications in various roles. Recently, he has focused extensively on Nitrosamine analysis in pharmaceuticals, utilizing both LCTQ and LCQTOF platforms, and has published multiple application notes. In his current role as a Technical Specialist for LC and GPC columns, he collaborates closely with customers across the US and Canada.