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June 10, 2025Critical Reviews in Analytical Chemistry

Innovations in the Detection of N-Nitrosamine Impurities in Pharmaceuticals: Analytical and Regulatory Challenges

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Authors

YAYunes M. M. A. AlsayadiChandigarh UniversityRDR.K.S. DograVAVimal AroraChandigarh University

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Implication

Literature review reveals analytical challenges in detecting trace carcinogenic nitrosamines across commercial drugs, highlighting the need for sensitive mass spectrometry and harmonized testing.

Key Points

  • To review the mechanisms of formation, toxicological implications, evolving regulatory guidelines, and advanced analytical strategies for monitoring trace N-nitrosamine impurities in pharmaceuticals.
  • Conducted a comprehensive literature search spanning 2018 to 2025 across PubMed, Web of Science, ScienceDirect, and Scopus.
  • Identified and evaluated studies focusing on nitrosamine impurities, N-nitrosodimethylamine (NDMA), and regulatory guidelines from agencies like the USFDA and EMA.
  • Critically assessed chromatographic and mass spectrometric workflows, sample preparation methods, and validation hurdles in complex drug matrices.
  • Trace-level quantification of N-nitrosamines remains analytically demanding due to their wide structural diversity and exceptionally low regulatory intake limits.
  • Liquid chromatography-mass spectrometry (LC-MS), gas chromatography-mass spectrometry (GC-MS), and high-resolution mass spectrometry (HRMS) provide the requisite sensitivity, but face persistent sample preparation and matrix-interference bottlenecks.

Cite This Study

Alsayadi et al. (2025) studied this question.

synapsesocial.com/papers/6a961dcb1ef7d57b8dee70f6https://doi.org/10.1080/10408347.2025.2512443
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Also Consider

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  1. 1Role of Carbonyl Compounds for N-Nitrosamine Formation during Nitrosation: Kinetics and Mechanisms2024 · 10 citations
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  4. 4Performance Characteristics of Mass Spectrometry-Based Analytical Procedures for Quantitation of Nitrosamines in Pharmaceuticals: Insights from an Inter-laboratory Study2023 · 15 citations
  5. 5Simultaneous Estimation of Six Nitrosamine Impurities in Valsartan Using Liquid Chromatographic Method2021 · 22 citations