Unraveling Nitrosamines: Navigating Compendial, Regulatory, and Analytical Challenges

Join us for an insightful webinar delving into the complexities surrounding nitrosamines in pharmaceutical products. Nitrosamines - known carcinogens, have emerged as a critical concern in the pharmaceutical industry, triggering stringent regulatory scrutiny. This webinar will explore the compendial standards, regulatory landscape, and analytical hurdles associated with detecting and mitigating nitrosamine contamination.

Gain invaluable insights from experts as we navigate the multifaceted challenges and discuss practical strategies for compliance and risk management.

Key Learnings:

• Best practices for conducting risk assessment and testing for nitrosamine impurities

• How to assess the risk associated with Nitrosamines and developing control strategies

• Workflow for 17 Nitrosamines covering Sample Prep and LC-MS/MS method

• Control strategies aimed at addressing sensitivity, selectivity, and reproducibility issues with particular emphasis on sample preparation challenges

Presenter: Dr. Amanda Guiraldelli, Ph.D (Scientific Affairs Manager, United States Pharmacopeia)

Amanda Guiraldelli has been with USP since 2012 and holds the position of scientific affairs manager. She also serves as scientific liaison for the USP Measurement and Data Quality Expert Committee, where she works to develop and revise USP standards related to analytical procedure lifecycle/validation. Previously, Amanda worked as senior scientist at the USP reference standard laboratory for 8 years with characterization of compendial standards. She is visiting professor at the Institute of Chemistry at the University of Campinas (UNICAMP) in Brazil and is a frequent speaker and instructor on topics related to analytical procedure life cycle, AQbD and Chromatography.

Amanda is specialist in mass spectrometry, chromatography, omics and chemometrics and has more than 15 years of experience in pharmaceutical R&D areas. Prior to joining USP, she was R&D scientist in a Brazilian pharmaceutical industry and visiting scientist at TU Berlin in Germany and Leiden University in Netherlands (Center for Proteomics and Metabolomics) working on proteins characterization by LC-HRMS and procedure development using UHPLC-HRMS. Amanda is graduated in pharmacy biochemistry and holds a Ph.D. in analytical chemistry from the FCFRP - University of São Paulo (metabolomics by UHPLC-HRMS, GC-MS and 1H NMR and chemometrics).

Presenter: Mr. Naiffer Romero (MSc, MPH, United States Pharmacopeia)

Naiffer has more than 19+ years of pharmaceutical industry experience. In his 15 years with USP, he has served several roles: lead scientist in performance testing compendial reference standards development, Manager in charge of LATAM Compendial engagement and education with stakeholders and national regulatory bodies, and certified USP Education instructor.

Naiffer joined USP’s Scientific Affair performance cell in 2020, where he leads scientific outreach and technical engagement for LATAM & US region on critical national health priority topics. His combined pharmaceutical expertise includes Analytical development, salt and polymorph selection, Development of dissolution methods, IVIVC modeling, and impurity analytical strategy. Naiffer is a recognized subject matter expert in Nitrosamines Impurities, and he also serves as a member of USP’s Nitrosamine workstream Committee and community manager to ‘Nitrosamine Exchange’, a knowledge community hosted by USP in All-things Nitrosamines Impurities.

Naiffer also liaises technical discussions on pharmacopeial collaboration, including the International Meeting of World Pharmacopeias (part of WHO), international compendial discussion groups, and several regional regulatory agencies’ nitrosamines working groups.

Presenter: Mr. Tobias Weimer (Produktspezialist LC & LC/MSD, Agilent Technologies)

Tobias hat in Marburg an der Philipps Universität Chemie studiert Seine Leidenschaft für die analytische Chemie und Chromatographie wurde bereits in der Oberschule geweckt und im Studium vertieft mit einer gezielten Ausrichtung auf analytische Trenntechniken. Über die Flüssigkeitschromatographie im Bereich LC Säulen führte Ihn sein Weg zu LC Systemen.