Nitrosated active pharmaceutical ingredients – lessons learned?

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

(2022) Sebastian Schmidtsdorff et al.   ARCHIV DER PHARMAZIE

Trace Level Quantification of 4-Methyl-1-nitrosopiperazin in Rifampicin Capsules by LC-MS/MS

(2022) Xiaosha Tao et al.   Frontiers in Chemistry

International Regulatory Collaboration on the Analysis of Nitrosamines in Metformin-Containing Medicines

(2022) David A. Keire et al.   AAPS Journal

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

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

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

Absolute Quantitation of N-Nitrosamines by Coulometric Mass Spectrometry without Using Standards

(2022) Qi Wang et al.   JOURNAL OF THE AMERICAN SOCIETY FOR MASS SPECTROMETRY

Letter to the editor of Heliyon re: determination of dimethylamine and nitrite in pharmaceuticals by ion chromatography to assess the likelihood of nitrosamine formation Heliyon. 2021; 77: e06179

(2022) Joerg Schlingemann et al.   Heliyon

N-Nitrosation in the absence of nitrosating agents in pharmaceuticals?

(2022) Jakub Jireš et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Prevalence of nitrosamine contaminants in drug samples: Has the crisis been overcome?

(2022) Sebastian Schmidtsdorff et al.   ARCHIV DER PHARMAZIE

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

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

(2022) Joerg Schlingemann et al.   JOURNAL OF PHARMACEUTICAL SCIENCES

N ‐nitrosodimethylamine‐Contaminated Valsartan and Risk of Cancer: A Nationwide Study of 1.4 Million Valsartan Users

(2022) Imène Mansouri et al.   Journal of the American Heart Association

Critical Analysis of Drug Product Recalls due to Nitrosamine Impurities

(2021) Sonali S. Bharate   JOURNAL OF MEDICINAL CHEMISTRY

Analytical lifecycle management for comprehensive and universal nitrosamine analysis in various pharmaceutical formulations by supercritical fluid chromatography

(2021) Sebastian Schmidtsdorff et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

The nitrosamine contamination of drugs, part 3: Quantification of 4-Methyl-1-nitrosopiperazine in rifampicin capsules by LC-MS/HRMS

(2021) Jonas Wohlfart et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

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

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

Developing Structure-Activity Relationships for N-Nitrosamine Activity

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

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

Risk assessment report of potential impurities in cetirizine dihydrochloride

(2020) Adrian Leistner et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

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

The contamination of valsartan and other sartans, part 1: New findings

(2019) Fritz Sörgel et al.   JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS

Determination of Chemical Stability of Two Oral Antidiabetics, Metformin and Repaglinide in the Solid State and Solutions Using LC-UV, LC-MS, and FT-IR Methods

(2019) Anna Gumieniczek et al.   MOLECULES

Critical review of major sources of human exposure to N -nitrosamines

(2018) Adam J. Gushgari et al.   CHEMOSPHERE

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

(2011) Yongmei Wu et al.   AAPS PHARMSCITECH