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Genotoxic effects of NDMA-contaminated ranitidine on Allium cepa cells and unveiling carcinogenic mechanisms via DFT and molecular dynamics simulation study.
Sci Rep
December 2024
Department of Genetic Engineering and Biotechnology, University of Rajshahi, Rajshahi, 6205, Bangladesh.
This study investigated the potential genotoxic and carcinogenic effects of N-nitrosodimethylamine (NDMA), a hazardous compound found in ranitidine formulations that are used to treat excessive stomach acid. The study first examined the effects of NDMA-contaminated ranitidine formulation on Allium cepa root growth and mitotic activity. The results demonstrated dose-dependent decreases in both root growth and mitotic index indicating genotoxicity and cell division disruption.
View Article and Find Full Text PDF[Determination of 8 N-nitrosamines in the workplace air by GC-MS/MS method].
Zhonghua Lao Dong Wei Sheng Zhi Ye Bing Za Zhi
August 2024
Central Laboratory, the Beijing Prevention and Treatment Hospital of Occupational Disease for Chemical Industry, Beijing 100093, China.
To establish a method for the determination of eight N-nitrosamines (N-nitrosodimethylamine, N-nitrosodimethylamine, N-nitrosomethylmethylamine, N-nitrosodibutylamine, N-nitrosopropylamine, N-nitrosomorpholine, N-nitrosodianiline and N-nitrosopiperidine) in the air of workplace by gas chromatography-tandem mass spectrometry (GC-MS/MS) . From January to August 2023, eight N-nitrosamines in the air of workplace were collected by ThermoSorb/N column, eluted with 4 ml methanol-dichloromethane (1∶1 volume ratio), separated by VF-624 ms capillary column, detected by multiple reaction monitoring mode and quantified by external standard method. The detection limit and precision of the method were also analyzed.
View Article and Find Full Text PDFN-nitrosamine impurity risk assessment in pharmaceuticals: Utilizing In vivo mutation relative potency comparison to establish an acceptable intake for NTTP.
Regul Toxicol Pharmacol
September 2024
Nonclinical Drug Safety, MRL, Merck & Co., Inc., Rahway, NJ, USA.
The finding of N-nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA) in marketed drugs has led to implementation of risk assessment processes intended to limit exposures to the entire class of N-nitrosamines. A critical component of the risk assessment process is establishing exposure limits that are protective of human health. One approach to establishing exposure limits for novel N-nitrosamines is to conduct an in vivo transgenic rodent (TGR) mutation study.
View Article and Find Full Text PDFDevelopment and validation of high-performance liquid chromatography-Orbitrap mass spectrometric method for quantification of NDMA in ranitidine drug products and evaluation of antioxidants as inhibitors of classical nitrosation reaction.
Rapid Commun Mass Spectrom
June 2024
Department of Pharmaceutical Analysis, National Institute of Pharmaceutical Education and Research (NIPER), Hajipur, Bihar, India.
Article Synopsis
- N-Nitroso dimethylamine (NDMA) is a harmful impurity found in ranitidine products, with the potential to form during storage due to the drug's chemical structure, prompting the FDA to recommend antioxidants as a solution.
- A sensitive liquid chromatography/high-resolution mass spectrometry (LC-HRMS) method was developed for detecting NDMA, achieving high sensitivity and precise quantification of NDMA levels in ranitidine samples.
- The study confirmed that antioxidants effectively reduce NDMA formation during nitrosation of ranitidine, with ascorbic acid being the most effective, significantly lowering NDMA levels by nearly 97%.
Evaluating the mutagenicity of N-nitrosodimethylamine in 2D and 3D HepaRG cell cultures using error-corrected next generation sequencing.
Arch Toxicol
June 2024
Division of Genetic and Molecular Toxicology, National Center for Toxicological Research, U.S. Food and Drug Administration, Jefferson, AR, 72079, USA.
Article Synopsis
- Human liver-derived HepaRG cells were used in both 2D and 3D formats to assess mutagenesis by exposing them to the chemical N-nitrosodimethylamine (NDMA) for 72 hours.
- The study measured cytotoxicity, DNA damage, micronucleus formation, and mutation frequency, finding that the 3D spheroids responded more significantly than the 2D cells.
- NDMA primarily caused A:T → G:C transitions in mutations, suggesting that the HepaRG models could serve as effective tools for genotoxicity testing, but caution is needed regarding cytotoxic concentration levels.
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