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June 10, 2026Current Analytical Chemistry

A Review on Nitrosamines Impurities in Pharmaceuticals-From Contamination Sources to Analytical Determination

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Authors

PMPaulo Roberto Rodrigues MartiniGCGraciela CarlosCPClésio Soldateli Paim

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Overview

Review presents contamination sources and analytical methods for nitrosamines in pharmaceuticals, highlighting urgent regulatory needs.

Key Points

  • This review aims to outline the presence and risks associated with nitrosamines in pharmaceuticals, focusing on contamination sources and regulatory needs.
  • Comprehensive literature review on nitrosamines including contamination sources, effects, and analytical methods
  • Discussion of physicochemical properties and regulatory guidelines related to nitrosamine detection
  • Recommendations for future pharmaceutical design to minimize nitrosamine risks
  • Identified multiple routes of contamination in pharmaceutical products, with specific focus on Angiotensin II Receptor Blockers
  • Highlights the need for adaptable regulatory frameworks to keep up with the evolving challenges of nitrosamine detection
  • Advocates for enhanced drug synthesis strategies to prevent nitrosamine formation

Cite This Study

Martini et al. (2026) studied this question.

synapsesocial.com/papers/6a28ff6a6f82f25be989c5fdhttps://doi.org/10.2174/0115734110444455260424075451
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