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The Presence of Nitrosamines and Nitrosamine Drug-Related Substances in Pharmaceutical Products: An Overview of Regulatory Concerns, Analytical Methodologies, and Control Strategies.
Curr Drug Saf
January 2025
Department of Chemistry, K J Somaiya College of Science and Commerce, Vidyavihar, Mumbai-77, India.
The presence of N-nitrosamine impurities in pharmaceutical products is well known. In 2019, it resulted in drug recall by the Food and Drug Administration (FDA). Soon, several groups identified the presence of many N-nitrosamines (NAs) in various Active Pharmaceutical Ingredients (APIs) and drug formulations worldwide.
View Article and Find Full Text PDFOptical and Electrical Dual-Mode Detection of a Carcinogenic Substance Based on Synergy of Liquid Crystals and Ionic Liquids.
ACS Sens
January 2025
School of Materials Science and Engineering, Tongji University, Shanghai 201804, P. R. China.
Visual, sensitive, and selective detection of carcinogenic substances is highly desired in portable health protection and practical medicine production. However, achieving this goal presents significant challenges with the traditional single-mode sensors reported so far, as they have limited sensing mechanisms and provide only a single output signal. Here, we report an effective optical and electrical dual-mode sensor for the visual, sensitive, and selective detection of -nitrosodiethylamine (NDEA), a typical volatile carcinogenic substance, leveraging the synergy of ionic liquid-doped liquid crystals (IL-LC).
View Article and Find Full Text PDFResolution of Historically Discordant Ames Test Negative / Rodent Carcinogenicity Positive N-nitrosamines using a Sensitive, OECD-aligned Design.
Mutagenesis
November 2024
GSK Research & Development, Stevenage, SG1 2NY, UK.
The in vitro Bacterial Reverse Mutation (Ames) Test is crucial for evaluating the mutagenicity of pharmaceutical impurities. For N-nitrosamines (NAs) historical data indicated that for certain members of this chemical class the outcomes of the Ames Test did not correlate with their associated rodent carcinogenicity outcomes. This has resulted in negative outcomes in an OECD aligned Ames Test alone (standard or enhanced) no longer being considered sufficient by regulatory authorities to assess potential carcinogenic risk of NAs if present as impurities in drug products.
View Article and Find Full Text PDFIndustrial Genotoxicology Group (IGG): 36th Annual Meeting Report.
Mutagenesis
October 2024
Safety Innovation, Clinical Pharmacology & Safety Sciences, R&D, AstraZeneca, Cambridge, UK.
The proceedings of the 36th annual meeting of the Industrial Genotoxicology Group (IGG) are shared here. The meeting held at Lhasa Limited, Leeds, UK on 28th November 2023, focussed two aspects; New Approach Methodologies (NAM's), including those for the assessment of non-standard modalities such as gas-vapour assessments and nanomaterials, and addressing the regulatory challenges associated with understanding the genotoxic and carcinogenic potential of N-nitrosamines and N-nitrosamine impurities. New approach methodologies, such as error-corrected sequencing and enhanced Ames tests that may help address these challenges were also discussed.
View Article and Find Full Text PDFSelection of solvent and positive control concentration for enhanced Ames test conditions for N-nitrosamine compounds.
Regul Toxicol Pharmacol
December 2024
Department of Pharmacology and Toxicology, Zydus Research Center, Zydus Lifesciences Limited, Ahmedabad, 382213, India. Electronic address:
The Ames test is a widely used bacterial mutagenicity assay to evaluate the potential of chemical compounds to induce mutations. In recent years, there has been growing concern regarding the presence of N-nitrosamines in pharmaceuticals, food, and other consumer products. N-Nitrosamines are probable mutagens and carcinogens.
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