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28 resultsUpdated October 24, 2026

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Analytical Methodologies to Detect N-Nitrosamine Impurities in Active Pharmaceutical Ingredients, Drug Products and Other Matrices

Chemical Research in Toxicology 37(9) (2024)

Krishna Moorthy Manchuri; Mahammad Ali Shaik; G. V. REDDY; Naziya Sultana; Sreenivasarao Gogineni

Innovations in the Detection of N-Nitrosamine Impurities in Pharmaceuticals: Analytical and Regulatory Challenges

Critical Reviews in Analytical Chemistry 56(7) (2025)

Yunes M. M. A. Alsayadi; Raghav Dogra; Vimal Arora; Aditya Shiven

Cost-effective, green HPLC determination of losartan, valsartan and their nitrosodiethylamine impurity: application to pharmaceutical dosage forms

Royal Society Open Science 9(6) (2022)

Soad S. Abd El‐Hay; Magda Elhenawee; Khaled Maged; Adel Ehab Ibrahim

Thymol-Based Hydrophobic Deep Eutectic Solvents as a Green Approach for Screening Polar Nitrosamines in Sartans Pharmaceutical Products by Ultrasound-Assisted Dispersive Liquid-Liquid Microextraction Combined with HPLC-DAD

Journal of Pharmaceutical Sciences 112(5) (2022)

Thiago Santana Novotný; Mychelle Alves Monteiro; Patrícia Condé de Lima; Soraya de Mendonça Ochs; Ricardo Luiz do Nascimento Maranho; Fernando Antônio Simas Vaz; Flávia Ferreira de Carvalho Marques

Development and validation of an analytical method for trace‐level quantification of genotoxic nitrosamine impurities in losartan and hydrochlorothiazide fixed‐dose combination tablets using ultra performance liquid chromatography triple quadrupole mass spectrometry

Rapid Communications in Mass Spectrometry 37(8) (2023)

Ravi Bharatkumar Patel; Ravi Bharatkumar Patel; Sanjay Purohit; Ravisinh Vikramsinh Solanki; Dignesh Khunt; Chhaganbhai N. Patel; Rucha Patel; Rucha Patel; Shalin Parikh

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

Journal of Chromatography A 1710 (2023)

Atsushi Ishizaki; Kazutaka Ozawa; Hiroyuki Kataoka

Microextraction by packed sorbent of N‐ nitrosamines from Losartan tablets using a high‐throughput robot platform followed by liquid chromatography‐tandem mass spectrometry

Journal of Separation Science 46(17) (2023)

Natalia Gabrielly Pereira dos Santos; Deyber Arley Vargas Medina; Fernando Mauro Lanças

Understanding How Chemical Pollutants Arise and Evolve in the Brewing Supply Chain: A Scoping Review

Foods 13(11) (2024)

Gabriel Pérez‐Lucas; Ginés Navarro; Simón Navarro

Development of a green-synthesized molecularly imprinted polymer-based electrochemical nanosensor for the determination of N-nitrosodimethylamine (NDMA) in serum and tap water

Microchimica Acta 191(12) (2024)

Nimisha Jadon; Ahmet Cetinkaya; Göksu Ozcelikay; S. Irem Kaya; Esen Bellur Atıcı; Lokman Uzun; Síbel A. Özkan

High‐Performance Liquid Chromatography–Tandem Mass Spectrometry Method Development and Validation for Simultaneous Determination of Seven Nitrosamine and Azidomethyl‐Biphenyl‐Tetrazole Impurities in Losartan

Journal of Separation Science 47(19) (2024)

Nguyen Minh Luan; Vo Thi Kim Khuyen; Nguyễn Đức Tuấn

Nitrosamine Control: From Risk Assessment to Analytical Testing with Emphasis on Sample Preparation and Phase-Appropriate Method Validation

Organic Process Research & Development 29(11) (2025)

Abhijit Tarafder; Edwin Vega; Hilary P. Beck; Devon A. Mundal; Mitul Tilala; Silas Wang

The Advancement of Analytical Techniques in Drug Development and Validation

Critical Reviews in Analytical Chemistry (2026)

Sk Manirul Haque; Abuzar Kabir; Nedal Y. Abu-Thabit; Akanksha Singh Kachhawaha; Pintu Prajapati; P.A. Sreekumar; Masoom Raza Siddiqui

Pharmaceutical Nitrosamines: A Comprehensive Review of Health Risks, Detection, Mitigation Strategies Supplemented with CYP450 Interactions as Molecular Simulations for Mechanistic Insight into Carcinogenicity

Molecular Pharmaceutics 22(9) (2025)

Kardile Punam Kashinath; Md Samim Sardar; Subhadeep Roy; Anoop Kumar; Santanu Kaity

A Pre-Column Derivatization Method for the HPLC-FLD Determination of Dimethyl and Diethyl Amine in Pharmaceuticals

Molecules 29(23) (2024)

Georgios Kamaris; Maria Tsami; Georgiana-Roxana Lotca; Sofia Almpani; Catherine K. Markopoulou

Development and Validation of an LC–MS/MS Method for Trace‐Level Nitrosamine Analysis in Mexiletine Formulations

Separation Science Plus 9(4) (2026)

Prasanth Katakam; Bharat Kumar Tripuramallu; E. Prashanth Kumar; Abhishek Sharma

Investigation of Carcinogenic Impurities of N-Nitrosamines in Sartan Pharmaceutical Products Marketed in Brazil: Development and Validation of Method Based on High-Performance Liquid Chromatography-Tandem Mass Spectrometry

Journal of Pharmaceutical Sciences 112(5) (2023)

Mychelle Alves Monteiro; Patrícia Condé de Lima; Thiago Santana Novotný; Daniela Silva Santana; Maria Emanuelle Damazio Lima; Anna Sophia Conhasco Lanzellotti Dantas; Laís Oliveira Dos Santos; Matheus Nicolau de Souza; Ricardo Luiz do Nascimento Maranho; Soraya de Mendonça Ochs

Simultaneous multianalyte trace-level quantification of eight genotoxic nitrosamine impurities in valsartan Active Pharmaceutical Ingredient and tablet formulation using UFLC-MS/MS and greenness assessment

Microchemical Journal 207 (2024)

Hemanth Vikram P R; Gunjan Kumar; Rajashree Deka; Narasimha Murthy Beeraka; Dilipkumar Reddy Kandula; Santosh Kapil Kumar Gorti; Namitha Bannimath; Pramod Kumar; Tegginamath Pramod Kumar; В.Н. Николенко; Bannimath Gurupadayya

A Review of Nitrosamine Management in Pharmaceuticals: From Source to Solution

Current Analytical Chemistry 22(6) (2025)

Ganesh D. Rahangdale; Krishna Radheshyam Gupta; Milind Janrao Umekar

Research progress of N -nitrosamine detection methods: a review

Bioanalysis 14(16) (2022)

Yahui Liu; Xingzhou Guo; Zhijuan Wang; Qing Zhang; Qiang Ma; Qing Lv

A voltammetric method for determining N-nitrosodimethylamine in losartan and olmesartan drugs

Journal of Pharmaceutical Sciences 114(2) (2025)

Tassio A. Nunes; Fernanda S. Soares; João V.M. Mariz; Luciano Bernardo Ramo; Rossana O. Nóbrega; Anabel S. Lourenço; Amanda C. Silva; Mário César Ugulino de Araújo

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

European Journal of Mass Spectrometry 31(1-2) (2025)

İbrahim DANİŞ; Durişehvar Özer Ünal

Analysis and risk assessment of nitrosamines in sartans using GC-MS and Monte Carlo simulation

Scientific Reports 15(1) (2025)

Fatemeh Shomali; Zahra Talebpour; Ghazaleh Abedi; Nilufar Mousavi; Shiva Mokhtarifar; Marjan Kohandani; Vahideh Mahdavi; Noushin Adib

Development and Validation of a Highly Sensitive LC‐MS/MS Method for the Quantification of N ‐Nitroso‐Desmethyl‐Zolmitriptan: A Nitrosamine Impurity in Zolmitriptan

Separation Science Plus 8(9) (2025)

Rajavenkata Prasad Patha; Karunakar Dasa; Rama Devi Bhoomireddy; Ravi Kiran Panchakarla; Sumanth Mullangi

Validated Reversed-Phase HPLC-PDA Quantitation of Three Nitrosamine Impurities in Valsartan Tablets Using Selective Acidic Sample Preparation

Analytical Letters (2026)

Antonis Giannopoulos; Dimitris Voulgaris; Ariadni Geballa-Koukoula; Eleni Kalogria; Constantinos Kousoulos; Constantinos M. Pistos; Irene Panderi

Recent Analytical Methods for N- Nitrosamine Analysis as Impurities in Drug Substances and Drug Products

Journal of Analytical Methods in Chemistry 2026(1) (2026)

Rimadani Pratiwi; Alifa Dhia Shalima; Mutakin Mutakin; Aliya Nur Hasanah