Losartan API and Nitrosamines Impurities-Stability Profile Investigation Using HPLC, LC-MS, and In Silico Assessment. [PDF]
J Sep SciABSTRACT Nitrosamines are potent genotoxic impurities with well reported mutagenic and carcinogenic effects. Their presence has been detected in several pharmaceutical products among them losartan, an angiotensin II receptor blocker. Considering the risks already reported for these impurities, the present study aimed to investigate the influence of ...
Martini PRR +6 more
europepmc +2 more sources
Adjusting the Preincubation Conditions to Enhance the Ames Test for Detecting the Mutagenicity of N-Nitrosamines. [PDF]
Environ Mol MutagenABSTRACT Conducting S9‐mediated preincubations at slightly acid pHs (e.g., pH 5.0 to pH 6.5) has been reported to enhance the mutagenicity of small‐molecule nitrosamines in the Ames test. In this study, we have evaluated the effect of adjusting the preincubation mix used in the Enhanced Ames Test (EAT) from pH 7.4 to pH 6.0 and supplying the activation
Bishop ME +11 more
europepmc +2 more sources
Sustainability in Analytical Chemistry Illustrated by Pharmaceutical Nitrosamine Testing. [PDF]
ElectrophoresisABSTRACT Following the valsartan scandal in 2018, the testing of drug substances and drug products for N‐nitrosamines has become a critical and mandatory quality control measure. The European Pharmacopoeia chapter 2.5.42 currently describes three analytical methods for this purpose: HPLC–MS/MS, GC–MS, and GC–MS/MS.
Bredendiek F, Schmidtsdorff S, Parr MK.
europepmc +2 more sources
Assessment and Risk Analysis of Nitrosamines in Sausages From Northern Iran. [PDF]
Food Sci NutrThis study evaluates nitrosamine levels in chicken and red meat sausages from northern Iran, identifying health risks for consumers. Using high‐performance liquid chromatography (HPLC), significant variations in nitrosamine concentrations were observed, with red meat sausages showing the highest levels.
Allahkhah MS, Movassaghghazani M.
europepmc +2 more sources
Evaluation and ranking of manufactured cars in Iran using Network Data Envelopment Analysis model [PDF]
Revista Română de Informatică și Automatică, 2020 Data Envelopment Analysis (DEA) is a mathematical programming-based approach to evaluating and ranking decision-making units (DMUs) with multiple inputs and outputs.
Kamran JALILIAN +1 more
doaj +1 more source
Cancer Cell International, 2011 Background/objective This study was designed to evaluate the potential chemopreventive activities of Ginkgo biloba extract (EGb) and Silybum marianum extract (silymarin) against hepatocarcinogenesis induced by N-nitrosodiethylamine (NDEA) in rats ...
El Mesallamy Hala O +4 more
doaj +1 more source
Amelioration of oxidative stress, inflammation and liver function by nutraceuticals in rat model of hepatic cancer initiation induced by N-nitrosodiethylamine [PDF]
Journal of HerbMed Pharmacology, 2021 Introduction: Nutraceuticals might serve as protective agent against liver cancer induced by pro-cancerous chemicals that initiate high oxidative stress, inflammation and affect DNA integrity.
Sahar Y. Al-Okbi +2 more
doaj +1 more source
Anais da Academia Brasileira de Ciências, 2010 N-nitroso compounds, such as N-nitrosodiethylamine (NDEA), can be formed by the reaction of secundary amines with nitrosating agents, and are suspected to be involved in tumors in humans.
Claudia R. de Rainho +3 more
doaj +1 more source
Presence of nitrosamine impurities in medicinal products
Arhiv za Higijenu Rada i Toksikologiju, 2021 In 2018, some sartan medicinal products were reported to be contaminated with nitrosamine compounds, which are potent mutagenic carcinogens. Two nitrosamines received particular attention: N -nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA ...
Sedlo Ilijana +2 more
doaj +1 more source
Mechanisms of hepatoprotective effects of white and black garlic extracts against preneoplastic lesions induced by N-nitrosodiethylamine in rats [PDF]
Journal of HerbMed Pharmacology, 2021 Introduction: Garlic has many pharmacological properties such as antibacterial, anti-inflammatory, and antioxidant activities. This study aimed to investigate the possible mechanisms of the hepatoprotective effect of white garlic extract (WGE) and black ...
Mostafa Abbas Shalaby +2 more
doaj +1 more source