Determination of Nitrosamine Drug Substance-Related Impurities Derived from Nortriptyline and Sertraline Using LC-MS/MS: A Comparative Evaluation of Chromatographic Separation and Pharmaceutical Application

<b>Background/Objectives</b>: Nitrosamine drug substance-related impurities (NDSRIs) are a class of potent genotoxic impurities that pose a critical risk to patient safety, thereby necessitating the stringent control of pharmaceutical products. Nortriptyline (NORT) and sertraline (SERT) are two wide...

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Bibliografische Detailangaben

Hauptverfasser:	Minki Shim, Ji Yeon Kim, Seungjin Jung, Minkyeong Hong, Sang Beom Han, Dong-Kyu Lee
Format:	Artigo
Sprache:	Inglês
Veröffentlicht:	MDPI AG 2025-11-01
Schriftenreihe:	Pharmaceuticals
Schlagworte:	nortriptyline sertraline antidepressant nitrosamine drug substance related impurities liquid chromatography-tandem mass spectrometry
Online-Zugang:	https://www.mdpi.com/1424-8247/18/11/1673
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