2,452
Views
24
CrossRef citations to date
0
Altmetric
Review Articles

Regulatory Updates and Analytical Methodologies for Nitrosamine Impurities Detection in Sartans, Ranitidine, Nizatidine, and Metformin along with Sample Preparation Techniques

, , & ORCID Icon
Pages 53-71 | Published online: 21 Jul 2020

Keep up to date with the latest research on this topic with citation updates for this article.

Read on this site (1)

Mohammed ALSaeedy, Arwa Al-Adhreai, Elif Mine Öncü-Kaya & Erol Şener. (2023) An Overview of Advances in the Chromatography of Drugs Impurity Profiling. Critical Reviews in Analytical Chemistry 53:7, pages 1455-1471.
Read now

Articles from other publishers (23)

Ravisinh Solanki, Pooja Wadhwana, Ravi Patel, Bhavinkumar Gayakvad, Charmy Kothari & Chhaganbhai Patel. (2023) Analytical Method Capable of Quantifying Eight Nitrosamine Impurities from Five Different Commercially Available Metformin Formulations with Glipizide, Glibenclamide, Gliclazide, Evogliptin, and Glimepiride by Ultra High Performance Liquid Chromatography Tripple Quadrupole Mass Spectrometry. Journal of Pharmaceutical Sciences 112:5, pages 1268-1276.
Crossref
Harshita Akkaraju, Ritik Tatia, Sayalee Sanjay Mane, Amol B. Khade & Swapnil J. Dengale. (2023) A comprehensive review of sources of nitrosamine contamination of pharmaceutical substances and products. Regulatory Toxicology and Pharmacology 139, pages 105355.
Crossref
Wisut Wichitnithad, Siriwan Nantaphol, Kachathong Noppakhunsomboon, Worathat Thitikornpong & Pornchai Rojsitthisak. (2023) Current status and prospects of development of analytical methods for determining nitrosamine and N-nitroso impurities in pharmaceuticals. Talanta 254, pages 124102.
Crossref
Wisut Wichitnithad, Siriwan Nantaphol, Kachathong Noppakhunsomboon & Pornchai Rojsitthisak. (2023) An update on the current status and prospects of nitrosation pathways and possible root causes of nitrosamine formation in various pharmaceuticals. Saudi Pharmaceutical Journal 31:2, pages 295-311.
Crossref
Marko Trampuž, Mateja Žnidarič, Fabrice Gallou & Zdenko Časar. (2022) Does the Red Shift in UV–Vis Spectra Really Provide a Sensing Option for Detection of N -Nitrosamines Using Metalloporphyrins? . ACS Omega 8:1, pages 1154-1167.
Crossref
Shanshan Chen, Yi Zhang, Qinghua Zhao, Yaodi Liu & Yun Wang. (2022) Simultaneous Determination for Nine Kinds of N-Nitrosamines Compounds in Groundwater by Ultra-High-Performance Liquid Chromatography Coupled with Triple Quadrupole Mass Spectrometry. International Journal of Environmental Research and Public Health 19:24, pages 16680.
Crossref
Mirela Paraschiv, Ion Smaranda, Irina Zgura, Paul Ganea, Madalina Chivu, Bogdan Chiricuta & Mihaela Baibarac. (2022) Degradation of Losartan Potassium Highlighted by Correlated Studies of Photoluminescence, Infrared Absorption Spectroscopy and Dielectric Spectroscopy. Pharmaceutics 14:11, pages 2419.
Crossref
Gangasani Jagadeesh Kumar, Sachin Dattram Pawar, Swati Ramesh Pawar, Abraroddin Mumtajoddin Khatib, Anurag Saini, Pintu Das, Kalyan K. Sethi, Pullapanthula Radhakrishnanand, Upadhyayula Suryanarayana Murty, P. L. Sahu, Sachin Dubey, Kapendra Sahu, Awanish Upadhyay, Rajesh Kumar Kori & Pramod Kumar. (2022) Process development for the total synthesis of the novel drug metabolite Carboxy toremifene as a standard reference material along with characterization and purity assessment for the Antidoping quality Control Purposes. Drug Testing and Analysis 14:11-12, pages 2002-2006.
Crossref
Feifei Luo, Yunya Liu, Yangguo Xie, Wei Hou, Lei Zhang & Zhongli Zhang. (2022) Simultaneous determination of 13 nitrosamine impurities in biological medicines using salting-out liquid-liquid extraction coupled with liquid chromatography tandem mass spectrometry. Journal of Pharmaceutical and Biomedical Analysis 218, pages 114867.
Crossref
Yahui Liu, Xingzhou Guo, Zhijuan Wang, Qing Zhang, Qiang Ma & Qing Lv. (2022) Research progress of N -nitrosamine detection methods: a review . Bioanalysis 14:16, pages 1123-1135.
Crossref
Ashish Miglani, Chandan Saini, Pankaj Musyuni & Geeta Aggarwal. (2021) A review and analysis of product recall for pharmaceutical drug product. Journal of Generic Medicines: The Business Journal for the Generic Medicines Sector 18:2, pages 72-81.
Crossref
Soad S. Abd El-Hay, Magda Elhenawee, Khaled Maged & Adel Ehab Ibrahim. (2022) Cost-effective, green HPLC determination of losartan, valsartan and their nitrosodiethylamine impurity: application to pharmaceutical dosage forms. Royal Society Open Science 9:6.
Crossref
Shardrack O. Asare, Jessica N. Hoskins, Richard A. Blessing & Russell L. Hertzler. (2022) Mass spectrometry based fragmentation patterns of nitrosamine compounds. Rapid Communications in Mass Spectrometry 36:8.
Crossref
K. Jony Susanna, Rahul Gajbhiye, Bhaskar Sarmah, Sachin Dattram Pawar, Pakhuri Mehta, Upadhyayula Suryanarayana Murty, V. Ravichandiran, Amit Alexander & Pramod Kumar. (2022) Simultaneous Method Development and Validation of Anastrozole Along with Piperine: Degradation Studies and Degradants Characterization Using LC-QTOF-ESI-MS Along with In-silico ADMET Predictions . Current Drug Metabolism 23:2, pages 113-130.
Crossref
Sachin D. Pawar, Gangasani J. Kumar, Aruna Chikkondra, Banwari Lal, P. Radhakrishnanand, Upadhyayula S. Murty, P. L. Sahu, Sachin Dubey, Arpit Soni & Pramod Kumar. (2021) Synthesis, characterization, method development, and validation of nor‐ethylmorphine hydrochloride reference material using established analytical techniques for dope control analysis. Drug Testing and Analysis 14:2, pages 388-392.
Crossref
Athira Joseph, Gangasani Jagadeesh Kumar, Sachin Dattram Pawar, Bhakti Umesh Hirlekar, Prasad V. Bharatam, Satyanand Konda, Mohana Krishna Reddy Mudiam, Upadhyayula Suryanarayana Murty, P. L. Sahu, Sachin Dubey, P. Radhakrishnanand, Daya Raju Adye, Roshan M. Borkar, Choppari Thirupathi & Pramod Kumar. (2021) Analytical developments of p ‐hydroxy prenylamine reference material for dope control research: Characterization and purity assessment . Drug Testing and Analysis 14:2, pages 224-232.
Crossref
Carmelo Scarpignato. 2022. Gastroesophageal Reflux in Children. Gastroesophageal Reflux in Children 273 305 .
Nahid Rehman & Anjana Pandey. (2022) An Overview of COVID-19 and Its Vaccines. Biology Bulletin Reviews 11:S1, pages 47-64.
Crossref
Amitkumar J. VyasJayshree P. GodhaniyaAjay I. PatelAshok B. PatelNilesh K. PatelAlpesh ChudasamaSunny R. Shah. (2021) A Review on Carcinogenic Impurities Found in Marketed Drugs and Strategies for its Determination by Analytical Methods. Asian Journal of Pharmaceutical Analysis, pages 159-169.
Crossref
Varun Sharma, Khaja Moinuddin Shaik, Archita Choudhury, Pramod Kumar, Prateek Kala, Yasmin Sultana, Rahul Shukla & Dalip Kumar. (2021) Investigations of process parameters during dissolution studies of drug loaded 3D printed tablets. Proceedings of the Institution of Mechanical Engineers, Part H: Journal of Engineering in Medicine 235:5, pages 523-529.
Crossref
Sonali S. Bharate. (2021) Critical Analysis of Drug Product Recalls due to Nitrosamine Impurities. Journal of Medicinal Chemistry 64:6, pages 2923-2936.
Crossref
P. P. Shchetinin, S. P. Senchenko & K. K. Gordeev. (2020) N-nitrosamine Impurities in Medicines: Toxicity, Formation Pathways, Methods of Determination, and Limits (Review). Drug development & registration 9:4, pages 180-190.
Crossref
Onkar Bedi, Amit Bandyopadhyay Banerjee, Thakur Gurjeet Singh, Sandeep Arora & Manisha Gupta. (2020) Ranitidine Induced Hepatotoxicity: A Review. Journal of Pharmaceutical Technology, Research and Management 8:1, pages 39-46.
Crossref

Reprints and Corporate Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

To request a reprint or corporate permissions for this article, please click on the relevant link below:

Academic Permissions

Please note: Selecting permissions does not provide access to the full text of the article, please see our help page How do I view content?

Obtain permissions instantly via Rightslink by clicking on the button below:

If you are unable to obtain permissions via Rightslink, please complete and submit this Permissions form. For more information, please visit our Permissions help page.