Exploration and detection of nitrosamine impurity nitroso-STG-19 in sitagliptin tablets and API as well as nitrites in excipients by LC-MS/MS methods

Yajie Hao, Juan Fu, Ruixia Wei, Hao Teng, Guang Yin, Qihui Cao, Zhong Feng and Guimin Zhang

Anal. Methods, 2024, 16, 5288
DOI: 10.1039/D4AY00967C

Development of a sensitive LC-MS/MS method for determination of N-nitrosopiperazine in levocetirizine

Yujin Lim, Aelim Kim, Yong-Moon Lee and Hwangeui Cho

Anal. Methods, 2024, 16, 6494
DOI: 10.1039/D4AY01067A

Development of a reliable method for determination of N-nitrosamines in medicines using disposable pipette extraction and HPLC-MS analysis

Almir Custodio Batista Junior, Yuri Arrates Rocha, Gabriela Guimarães Souza and Andréa Rodrigues Chaves

Anal. Methods, 2024, 16, 3318
DOI: 10.1039/D4AY00554F

Simultaneous determination of genotoxic nitrosamine impurities in sitagliptin/metformin combination tablets: comparative evaluation of ionisation techniques coupled with LC-MS/MS and high-resolution mass spectrometry

Hyojeong Lee, Minki Shim, Seungjin Jung, Sang Beom Han and Dong-Kyu Lee

Anal. Methods, 2025
DOI: 10.1039/D5AY01001B

Assessment of Nitrosamine Impurities in Lurasidone Hydrochloride Using APCI‐LC–MS/MS in MRM Mode for Regulatory Compliance and Stability Evaluation

Anant D. Yadav, Ashish C. Alaspure, Pinal S. Bhavsar, Sandesh R. Lodha and Anil H. Gore

Rapid Comm Mass Spectrometry, 2025, 39
DOI: 10.1002/rcm.10126

A practical HPLC-MS method for the analysis of nitrosamine drug substance related impurities using an inexpensive single quadrupole mass spectrometer

Jinjian Zheng, Christine L. Radich, Xiaoyi Gong, Xihui Liang and Mark D. Mowery

Journal of Chromatography A, 2024, 1736, 465399
DOI: 10.1016/j.chroma.2024.465399

Quantitative analysis of nitrosamine impurities using liquid chromatography tandem mass spectrometry

PhanikumarReddy Satti, Bhaskar Vallamkonda, Shubham Sharma and Vinod

Pure and Applied Chemistry, 2025
DOI: 10.1515/pac-2024-0397

Simultaneous Determination and Quantification of NineNitrosamine Impurities in Semi-Solid Forms Using a GC–MS/MS Method

Namjin Lee, Hyejin Go and Young-joon Park

Separations, 2025, 12, 120
DOI: 10.3390/separations12050120

Trace level quantification of N-nitrosorasagiline in rasagiline tablets by LC-TQ-MS/MS

Ravi Patel, Mansi Patel, Ravisinh Solanki and Dignesh Khunt

Annales Pharmaceutiques Françaises, 2024, 82, 771
DOI: 10.1016/j.pharma.2024.03.006

Comprehensive UHPLC–MS screening methods for the analysis of triazolopyrazine precursor and its genotoxic nitroso-derivative in sitagliptin pharmaceutical formulation

Jakub Jireš, Michal Douša, Petr Gibala, Jan Doubský, Daniel Pěček, David Mervart, Anna Kluk, Ardita Veseli, Stanislav Kalášek and Pavel Řezanka

Journal of Pharmaceutical and Biomedical Analysis, 2024, 238, 115861
DOI: 10.1016/j.jpba.2023.115861

Quantitative LC‐MS/MS Method for Simultaneous Quantification of N‐Nitroso‐Berotralstat and N‐Nitroso‐Boc‐Berotralstat in Berotralstat.HCl

Nagaraju Rajana and Shiva Kumar Kota Balaji

Separation Science Plus, 2025, 8
DOI: 10.1002/sscp.70046

Simultaneous analysis of carcinogenic N-nitrosamine impurities in metformin tablets using on-line in-tube solid-phase microextraction coupled with liquid chromatography-tandem mass spectrometry

Atsushi Ishizaki, Kazutaka Ozawa and Hiroyuki Kataoka

Journal of Chromatography A, 2023, 1710, 464416
DOI: 10.1016/j.chroma.2023.464416

Bumetanide as a Model NDSRI Substrate: N-nitrosobumetanide Impurity Formation and its Inhibition in Bumetanide Tablets

Diaa Shakleya, Bethel Asmelash, Alaadin Alayoubi, Nicolas Abrigo, Adil Mohammad, Jiang Wang, Jinhui Zhang, Jingyue Yang, Tim Andres Marzan, David Li, Maha Shaklah, Fahd M. Alsharif, Saaniya Desai, Patrick J. Faustino, Muhammad Ashraf, Thomas O'Connor, Matthew Vera, Andre Raw, Vilayat A. Sayeed and David Keire

Journal of Pharmaceutical Sciences, 2023, 112, 3075
DOI: 10.1016/j.xphs.2023.06.013

LC-ESI-MS/MS method for the accurate quantification of eight nitrosamines in pharmaceutical products

Ibrahim Danis and Durisehvar Ozer Unal

Eur J Mass Spectrom (Chichester), 2025, 31, 51
DOI: 10.1177/14690667251328823

Green and sustainable LC-APCI-MS/MS method for simultaneous quantification of genotoxic nitrosamines in antidiabetic medication: sitagliptin

Sriram Pepakayala, Venkata Nadh Ratnakaram, Yuvaraj Zunjarrao and Yogesh Kumar Lohia

BMC Chemistry, 2025, 19
DOI: 10.1186/s13065-025-01503-4