Quantitative analysis of nitrosamine impurities using liquid chromatography tandem mass spectrometry DOI
PhanikumarReddy Satti, Bhaskar Vallamkonda, Shubham Sharma

et al.

Pure and Applied Chemistry, Journal Year: 2025, Volume and Issue: unknown

Published: April 8, 2025

Abstract Due to their potential carcinogenic and genotoxic effects on human health, nitrosamine impurities have become a significant concern for regulatory agencies globally. Thus, there is need highly sensitive specific analytical methods capable of detecting trace levels nitrosamines. Liquid chromatography tandem mass spectrometry (LC-MS/MS) has the method choice identifying quantifying these due its unparalleled sensitivity, selectivity, precision. Regulatory bodies such as United States Food Drug Administration, European Medicines Agency, International Council Harmonisation, World Health Organization emphasize importance addressing hazards, providing updated guidance manufacturers applicants. The key objective this review examine recent advancements in LC-MS/MS analysis, focusing detection limits, precision, accuracy, matrix ensure potentially compliance with global guidelines.

Language: Английский

Quantitative analysis of nitrosamine impurities using liquid chromatography tandem mass spectrometry DOI
PhanikumarReddy Satti, Bhaskar Vallamkonda, Shubham Sharma

et al.

Pure and Applied Chemistry, Journal Year: 2025, Volume and Issue: unknown

Published: April 8, 2025

Abstract Due to their potential carcinogenic and genotoxic effects on human health, nitrosamine impurities have become a significant concern for regulatory agencies globally. Thus, there is need highly sensitive specific analytical methods capable of detecting trace levels nitrosamines. Liquid chromatography tandem mass spectrometry (LC-MS/MS) has the method choice identifying quantifying these due its unparalleled sensitivity, selectivity, precision. Regulatory bodies such as United States Food Drug Administration, European Medicines Agency, International Council Harmonisation, World Health Organization emphasize importance addressing hazards, providing updated guidance manufacturers applicants. The key objective this review examine recent advancements in LC-MS/MS analysis, focusing detection limits, precision, accuracy, matrix ensure potentially compliance with global guidelines.

Language: Английский

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