For those who have not seen it yet, Waters is hosting a 1hr webinar next week, led by @MTwohig & @mayank.bhanti
Episode 26- Advancing Nitrosamine Analysis: USP Frameworks and LC-MS/MS Solutions
Episode 26- Advancing Nitrosamine Analysis: USP Frameworks and LC-MS/MS Solutions
Please join the USP and Waters Corporation for Episode 26 of our joint series, which will focus on the current scientific, regulatory, and analytical approaches for addressing nitrosamine impurities in pharmaceutical products. The presentations will cover evolving industry expectations, available USP resources and frameworks, and practical LC-MS/MS strategies for the detection and quantification of NDBA and other nitrosamines
AGENDA:
USP’s Analytical Framework for Nitrosamines: Decoding the Puzzle with Compendial and Non‑Compendial Solutions
Nitrosamines have emerged as critical pharmaceutical impurities requiring a robust, science-based analytical and risk mitigation strategy. In response to global regulatory expectations, the United States Pharmacopeia (USP) has developed a comprehensive Analytical Framework for Nitrosamines that integrates both compendial and non-compendial solutions to support industry and regulators. Dr Mayank Bhanti will discuss the framework, which encompasses compendial solutions, including documentary standards, fit-for-purpose reference standards, and targeted USP education courses designed to strengthen laboratory capability and regulatory alignment. In parallel, non-compendial solutions are highlighted, such as emerging standards, scientific publications, nitrosamine exchange knowledge-sharing initiatives, risk assessment tool and the Analytical Hub.
Application of a Delay Column to Reduce Persistent Interference in the LC-MS/MS Analysis of NDBA in Normal Saline Infusion Bags
The second presentation will discuss the development of an LC-MS/MS method for detecting and quantifying N-nitrosodibutylamine (NDBA) and other small dialkyl nitrosamines in normal saline (0.9% NaCl) IV infusion bags, in the context of increasing regulatory scrutiny of nitrosamine impurities since 2018. Dr Marian Twohig will review the evolution of nitrosamine risk assessment from small molecule nitrosamines such as NDMA and NDEA to Nitrosamine Drug Substance Related Impurities (NDSRIs) and address the FDA CDER’s August 2025 Emerging Scientific and Technical Information notice highlighting concerns about NDBA detected in infusion bag drug products. Particular emphasis will be placed on analytical challenges associated with persistent interference from components sharing identical MRM transitions and retention times with NDBA, and how the application of a delay column was successfully used to mitigate these interferences and improve analytical specificity in LC-MS/MS analysis of sterile parenteral infusion products.