Study on the Detection Method of Nitrosamines in Livestock Food [PDF]
E3S Web of Conferences, 2021 In view of the complex and cumbersome problems in the detection of nitrosamines in the past, this article optimizes the detection method of nitrosamines in livestock food and establishes a more complete detection method of nitrosamines.
Xiaolin Hou
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Advances in New Approach Methodologies at FDA's Division of Applied Regulatory Science. [PDF]
Clin Pharmacol TherNew Approach Methodologies (NAMs) represent a paradigm shift in drug development and regulatory science, offering human‐relevant alternatives to traditional preclinical models. This mini‐review highlights recent advances in NAM development, validation, and regulatory application from FDA's Division of Applied Regulatory Science (DARS).
Blinova K +9 more
europepmc +2 more sources
A Rapid and Sensitive LC-MS/MS Method for Quantification of NDSRI in Melatonin Drug Product via Controlled In Situ Formation. [PDF]
Biomed ChromatogrABSTRACT Nitrosamine drug substance–related impurities (NDSRIs) pose a significant safety risk due to their mutagenic and carcinogenic potential, prompting strict regulatory oversight under ICH M7. The propensity for in situ formation of NDSRIs during analytical procedures, particularly in active pharmaceutical ingredients containing reactive amines ...
Yalamanchili J, Himavathi G, Suresh S.
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Comprehensive Assessment of Nitrosamine Formation in Meat Products Using UHPLC-HRMS: Analytical Challenges and Potential Dietary Implications [PDF]
MoleculesNitrosamines (NAs) pose a risk due to their carcinogenic properties, especially in processed and cured meats where nitrites and nitrates are widely used.
Tiziana Nardin +4 more
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Colorimetric Detection of Nitrosamines in Human Serum Albumin Using Cysteine-Capped Gold Nanoparticles [PDF]
SensorsNitrosamines, including N-nitroso diethylamine (NDEA) have emerged as pharmaceutical impurities and carcinogenic environmental contaminants of grave public health safety concerns.
Sayo O. Fakayode +6 more
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Nitrosamines in medicinal products [PDF]
Farmacja Polska, 2022 Nitrosamines are compounds that have a harmful effect on the organisms of animals and humans. The first information about their teratogenic, mutagenic, and genotoxic effects appeared in the mid-twentieth century.
Katarzyna Dominiak +2 more
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N-nitrosamines in processed meats: Exposure, formation and mitigation strategies
Journal of Agriculture and Food Research, 2023 Nitrite and nitrate have been widely used in the preservation of meat products for the effective antimicrobial action against several pathogenic bacteria such as Clostridium botulinum, Salmonella and mesophilic bacteria.
Yingfeng Xie +7 more
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Toxics, 2021 Nitrosamines can be produced during the manufacture of rubber-type products such as pacifiers or the nipples of baby bottles. Humans can be exposed to the nitrosamines in these products when they are eluted into saliva.
Hyungsoo Kim +7 more
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Lipid metabolism disorders contribute to hepatotoxicity of ICR mice induced by nitrosamines exposure
Environment International, 2022 Health risks caused by crucial environmental carcinogens N-nitrosamines triggered ubiquitous attention. As the liver exerted vital function through metabolic process, lipid metabolism disorders have been confirmed as potential drivers for toxicological ...
Hu Zhang +9 more
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The EU Response to the Presence of Nitrosamine Impurities in Medicines
Frontiers in Medicine, 2021 The unexpected detection of nitrosamine impurities in human medicines has recently seen global regulators act to understand the risks of these contaminations to patients and to limit their presence.
Robin Ruepp +7 more
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