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September 19, 2025Current Topics in Medicinal Chemistry

The Nitrite-Amines Nexus in Nitrosamine Formation: Mechanisms, Mutagenic Implications, Regulations, and Root Causes in Medicines

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Authors

YAYunes M. M. A. AlsayadiASAditya ShivenAKAtul Kabra

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Overview

Literature review shows mechanisms and regulations for nitrosamine formation in pharmaceuticals, indicating health risks.

Key Points

  • Nitrosamines are carcinogenic compounds formed from reactions involving amines and nitrosating agents, posing health risks.
  • Trace detection methods like LC-MS and GC-MS are essential for monitoring nitrosamines in Active Pharmaceutical Ingredients.
  • Regulatory agencies, notably the FDA and EMA, have set limits and requirements for nitrosamine risk assessments in pharmaceuticals.
  • Prevention of nitrosamine contamination relies on stringent risk evaluation and adherence to manufacturing regulations.

Cite This Study

Alsayadi et al. (2025) studied this question.

synapsesocial.com/papers/68d43706713b0b5dfea76ee8https://doi.org/10.2174/0115680266379308250827055006
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Also Consider

Synapse has enriched 5 closely related papers on similar clinical questions. Consider them for comparative context:

  1. 1Pharmaceutical Nitrosamines: A Comprehensive Review of Health Risks, Detection, Mitigation Strategies Supplemented with CYP450 Interactions as Molecular Simulations for Mechanistic Insight into Carcinogenicity2025
  2. 2A Review on Synthesis and Biological Activities of Nitrosamine Impurities in Active Pharmaceutical Ingredients (APIs)2025
  3. 3Computational Mechanistic Study on N-Nitrosation Reaction of Secondary Amines2025
  4. 4Development and Application of Analytical Methods to Quantitate Nitrite in Excipients and Secondary Amines in Metformin API at Trace Levels Using Liquid Chromatography–Tandem Mass Spectrometry2025
  5. 5Navigating The N-Nitrosamine Impurities Challenge: Comprehensive Strategies For Ensuring Paracetamol Purity Through Analytical Advances, Control Measures, And Emerging Mitigation Trends2024