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October 15, 2025International journal of research and scientific innovationOpen Access

A Review on Synthesis and Biological Activities of Nitrosamine Impurities in Active Pharmaceutical Ingredients (APIs)

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Authors

PDPrasadS DalviSSSharad S Sankhe

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Overview

This review discusses the formation of nitrosamine impurities in pharmaceuticals, highlighting their carcinogenic potential and analytical detection methods.

Key Points

  • Nitrosamine impurities formed during API manufacturing are carcinogenic and genotoxic, raising safety concerns.
  • Validated analytical methods like HPLC and GC are crucial for quantifying nitrosamine impurities effectively.
  • Understanding the synthesis of nitrosamines from secondary amines during manufacturing can help mitigate risks.
  • Identifying nitrosamine impurities involves highly sensitive techniques such as MS and NMR to ensure product safety.

Cite This Study

Dalvi et al. (2025) studied this question.

synapsesocial.com/papers/68efa18f9d05deea71d13e57https://doi.org/10.51244/ijrsi.2025.120800343
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Also Consider

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  1. 1The Nitrite-Amines Nexus in Nitrosamine Formation: Mechanisms, Mutagenic Implications, Regulations, and Root Causes in Medicines2025
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  3. 3Development 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
  4. 4Navigating The N-Nitrosamine Impurities Challenge: Comprehensive Strategies For Ensuring Paracetamol Purity Through Analytical Advances, Control Measures, And Emerging Mitigation Trends2024
  5. 5Carbon Quantum Dots-Based Fluorometric Detection of Nitrosamines Impurities in Active Pharmaceutical Ingredients2025