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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. AlsayadiChandigarh UniversityASAditya ShivenChandigarh UniversityAKAtul KabraChandigarh University

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Overview

Literature review reveals pathways and controls for nitrosamines in pharmaceuticals, suggesting stronger regulations are needed.

Key Points

  • Nitrosamines are genotoxic impurities formed from reactions between amines and nitrosating agents, impacting pharmaceutical safety.
  • Sensitive techniques like LC-MS and GC-MS allow for effective trace detection of nitrosamines in Active Pharmaceutical Ingredients.
  • The FDA and EMA have established Acceptable Intake limits for nitrosamines, emphasizing the importance of regulatory compliance.
  • Environmental factors and variability in excipient composition complicate prevention efforts, necessitating product-specific evaluations.

Cite This Study

Alsayadi et al. (2025) studied this question.

synapsesocial.com/papers/68d46cd731b076d99fa6955fhttps://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. 1Review on Nitrosamine: A Potential Genotoxic Impurity2025 · 1 citations
  2. 2Nitrosamine contamination of pharmaceuticals: Cases in Japan, formation mechanisms, detection methods, regulatory perspectives, and insights2024 · 12 citations
  3. 3Pharmaceutical Nitrosamines: A Comprehensive Review of Health Risks, Detection, Mitigation Strategies Supplemented with CYP450 Interactions as Molecular Simulations for Mechanistic Insight into Carcinogenicity2025 · 7 citations
  4. 4Innovations in the Detection of N-Nitrosamine Impurities in Pharmaceuticals: Analytical and Regulatory Challenges2025 · 9 citations
  5. 5Unraveling nitrosamine-induced carcinogenesis: toxicological aspects and molecular insights2025