2024
DOI: 10.1002/jssc.202400277
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High‐Performance Liquid Chromatography–Tandem Mass Spectrometry Method Development and Validation for Simultaneous Determination of Seven Nitrosamine and Azidomethyl‐Biphenyl‐Tetrazole Impurities in Losartan

Nguyen Minh Luan,
Vo Thi Kim Khuyen,
Nguyen Duc Tuan

Abstract: Nitrosamine‐related impurities (N‐nitrosomethylamino butyric acid [NMBA], N‐nitrosodiethylamine [NDEA], N‐nitrosodiisopropylamine [NDIPA], N‐nitrosomethylphenylamine [NMPA], N‐nitrosodibutylamine [NDBA], N‐nitrosodimethylamine [NDMA], and N‐nitrosoethylisopropylamine [NEIPA]) and 5‐[4'‐(azidomethyl)‐[1,1'‐biphenyl]‐2‐yl]‐2H‐tetrazole (AZBT) formed during the manufacture of sartan medicines have been classified into human mutagens and carcinogens after long‐term treatment. The study developed a simple, economic… Show more

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