NDMA Formation Due to Active Ingredient Degradation and Nitrite Traces in Drug Product

Risk assessment for nitrosated pharmaceuticals: A future perspective in drug development

(2022) Sebastian Schmidtsdorff et al.   ARCHIV DER PHARMAZIE

Metabolic Activation and DNA Interactions of Carcinogenic N-Nitrosamines to Which Humans Are Commonly Exposed

(2022) Yupeng Li et al.   INTERNATIONAL JOURNAL OF MOLECULAR SCIENCES

Avoiding N-nitrosodimethylamine formation in metformin pharmaceuticals by limiting dimethylamine and nitrite

(2022) Joerg Schlingemann et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

Nitrocellulose blister material as a source of N-nitrosamine contamination of pharmaceutical drug products

(2022) Nejc Golob et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

A Nitrite Excipient Database: A useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products

(2022) Ruth Boetzel et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

In-use stability assessment of FDA approved metformin immediate release and extended release products for N-Nitrosodimethylamine and dissolution quality attributes

(2022) Sathish Dharani et al.   INTERNATIONAL JOURNAL OF PHARMACEUTICS

NDMA analytics in metformin products: Comparison of methods and pitfalls

(2021) Matthias Fritzsche et al.   EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES

Pathways for N-nitroso compound formation: secondary amines and beyond

(2020) Rocio López-Rodríguez et al.   ORGANIC PROCESS RESEARCH & DEVELOPMENT

Potential for the Formation of N-Nitrosamines During the Manufacture of Active Pharmaceutical Ingredients: An Assessment of the Risk Posed by Trace Nitrite in Water

(2020) Ian W. Ashworth et al.   ORGANIC PROCESS RESEARCH & DEVELOPMENT

Ranitidine—Investigations into the Root Cause for the Presence of N-Nitroso-N,N-dimethylamine in Ranitidine Hydrochloride Drug Substances and Associated Drug Products

(2020) Fiona J. King et al.   ORGANIC PROCESS RESEARCH & DEVELOPMENT

N -nitrosamines in drinking water and beer: Detection and risk assessment

(2018) Chun-Cheng Fan et al.   CHEMOSPHERE

Determination of N -nitrosamines in cosmetic products by vortex-assisted reversed-phase dispersive liquid-liquid microextraction and liquid chromatography with mass spectrometry

(2018) Pablo Miralles et al.   JOURNAL OF SEPARATION SCIENCE

NDMA impurity in valsartan and other pharmaceutical products: Analytical methods for the determination of N-nitrosamines

(2018) Maria Kristina Parr et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Tobacco-Specific Nitrosamines in the Tobacco and Mainstream Smoke of U.S. Commercial Cigarettes

(2016) Selvin H. Edwards et al.   CHEMICAL RESEARCH IN TOXICOLOGY

Dietary Nitrates, Nitrites, and Nitrosamines Intake and the Risk of Gastric Cancer: A Meta-Analysis

(2015) Peng Song et al.   Nutrients

Tobacco-Specific Nitrosamines in Electronic Cigarettes: Comparison between Liquid and Aerosol Levels

(2015) Konstantinos Farsalinos et al.   International Journal of Environmental Research and Public Health

Reactive Impurities in Excipients: Profiling, Identification and Mitigation of Drug–Excipient Incompatibility

(2011) Yongmei Wu et al.   AAPS PHARMSCITECH

Development of estimates of dietary nitrates, nitrites, and nitrosamines for use with the short willet food frequency questionnaire

(2009) John S Griesenbeck et al.   Nutrition Journal