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August 17, 2025ChemosensorsOpen Access

Development and Application of Analytical Methods to Quantitate Nitrite in Excipients and Secondary Amines in Metformin API at Trace Levels Using Liquid Chromatography–Tandem Mass Spectrometry

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Authors

IAIl‐Young AhnSLSo‐Yeon LeeMJMin Jung

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Overview

This study developed methods for detecting nitrite and secondary amines in metformin, indicating measures to reduce nitrosamine contamination.

Key Points

  • Detecting nitrite levels in excipients varied from <LOQ to 4.74 ppm, showing significant contamination risks across samples.
  • The validation of methods was successfully conducted according to ICH guidelines, ensuring accuracy for detecting trace contaminants.
  • Liquid chromatography–tandem mass spectrometry was utilized, optimizing electrospray ionization for effective trace analysis of amines.
  • Implementing these methods highlights the necessity for proactive safety measures in pharmaceutical manufacturing to manage nitrosamine risks.

Cite This Study

Ahn et al. (2025) studied this question.

synapsesocial.com/papers/68a35152234c60ad5c20d11bhttps://doi.org/10.3390/chemosensors13080307
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Also Consider

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

  1. 1The Nitrite-Amines Nexus in Nitrosamine Formation: Mechanisms, Mutagenic Implications, Regulations, and Root Causes in Medicines2025
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  3. 3A Review on Synthesis and Biological Activities of Nitrosamine Impurities in Active Pharmaceutical Ingredients (APIs)2025
  4. 4<i>N</i>-Nitrosamine Quantitation in Pharmaceuticals by Tandem Mass Spectrometry2025
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