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September 10, 2025Separation Science Plus

Ultrasensitive Liquid Chromatography Triple Quadrupole Mass Spectrometry Detection and Quantification of N‐Nitroso‐Meglumine in Tafamidis Meglumine Capsules Using Electrospray Ionization

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Authors

KTKunjal ThakkarRSRavisinh SolankiRPRavi Patel

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Overview

This method reveals a reliable approach for detecting nitrosamine impurities in pharmaceuticals, pointing to improved drug safety compliance.

Key Points

  • The method ensures high sensitivity with a limit of detection of 0.5 ng/mL for n‐nitroso‐meglumine.
  • Results demonstrated excellent linearity over a range of 100–300 ng/mL, crucial for regulatory compliance.
  • Using liquid chromatography and triple quadrupole mass spectrometry, the study provides a novel quantification method.
  • This validated approach enhances the monitoring of nitrosamine impurities in tafamidis meglumine capsules for drug safety.

Cite This Study

Thakkar et al. (2025) studied this question.

synapsesocial.com/papers/68c23ed7b210217d64794a2bhttps://doi.org/10.1002/sscp.70091
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