The Landscape of Potential Small and Drug Substance Related Nitrosamines in Pharmaceuticals

Practical and Science-Based Strategy for Establishing Acceptable Intakes for Drug Product N-Nitrosamine Impurities

(2022) Krista L. Dobo et al.   CHEMICAL RESEARCH IN TOXICOLOGY

Metabolism and DNA Adduct Formation of Tobacco-Specific N-Nitrosamines

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

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

What Makes a Potent Nitrosamine? Statistical Validation of Expert-Derived Structure–Activity Relationships

(2022) Robert Thomas et al.   CHEMICAL RESEARCH IN TOXICOLOGY

Genotoxicity evaluation of a valsartan-related complex N-nitroso-impurity

(2022) Susanne Glowienke et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Strategies for Assessing Acceptable Intakes for Novel N-Nitrosamines Derived from Active Pharmaceutical Ingredients

(2022) David J. Ponting et al.   Journal of Medicinal Chemistry

N-Nitrosodimethylamine formation in metformin hydrochloride sustained-release tablets: Effects of metformin and hypromellose used in drug product formulation

(2022) Gugu Hao et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Tolerability of Risk: A commentary on the nitrosamine contamination issue

(2021) David P. Elder et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Enhancing Carbon Acid pKa Prediction by Augmentation of Sparse Experimental Datasets with Accurate AIBL (QM) Derived Values

(2021) Jeffrey Plante et al.   MOLECULES

Utilisation of parametric methods to improve percentile-based estimates for the carcinogenic potency of nitrosamines

(2021) Robert Thomas et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Acyclic Twisted Amides

(2021) Guangrong Meng et al.   CHEMICAL REVIEWS

Inhibition of N-Nitrosamine Formation in Drug Products: A Model Study

(2021) Kausik K. Nanda et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

Nitrosamine Reactivity: A Survey of Reactions and Purge Processes

(2021) Christopher J. Borths et al.   ORGANIC PROCESS RESEARCH & DEVELOPMENT

Use of less-than-lifetime (LTL) durational limits for nitrosamines: Case study of N-Nitrosodiethylamine (NDEA)

(2021) Joel P. Bercu et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

Developing Structure-Activity Relationships for N-Nitrosamine Activity

(2021) Kevin P. Cross et al.   Computational Toxicology

A Cautionary Tale: Quantitative LC-HRMS Analytical Procedures for the Analysis of N-Nitrosodimethylamine in Metformin

(2020) Jingyue Yang et al.   AAPS Journal

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

Are all nitrosamines concerning? A review of mutagenicity and carcinogenicity data

(2020) Andrew Thresher et al.   REGULATORY TOXICOLOGY AND PHARMACOLOGY

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

New and Potent Quinuclidine-Based Antimicrobial Agents

(2019) Andreja Radman Kastelic et al.   MOLECULES

DFT and AIM Study of the Protonation of Nitrous Acid and the pKaof Nitrous Acidium Ion

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