Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies
Published 2023 View Full Article
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Title
Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies
Authors
Keywords
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Journal
ORGANIC PROCESS RESEARCH & DEVELOPMENT
Volume 27, Issue 10, Pages 1736-1750
Publisher
American Chemical Society (ACS)
Online
2023-07-21
DOI
10.1021/acs.oprd.3c00153
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Note: Only part of the references are listed.- Regulatory Experiences with Root Causes and Risk Factors for Nitrosamine Impurities in Pharmaceuticals
- (2023) Stephen Horne et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Current threat of nitrosamines in pharmaceuticals and scientific strategies for risk mitigation
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- Nitroso Impurities in Drug Products: An Overview of Risk Assessment, Regulatory Milieu, and Control Strategy
- (2023) Naseem A. Charoo et al. AAPS PHARMSCITECH
- Solid State Kinetics of Nitrosation Using Native Sources of Nitrite
- (2023) Laure-Elie Carloni et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- NDMA Formation Due to Active Ingredient Degradation and Nitrite Traces in Drug Product
- (2023) Nejc Golob et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Formation of Dialkyl-N-nitrosamines in Aqueous Solution: An Experimental Validation of a Conservative Predictive Model and a Comparison of the Rates of Dialkyl and Trialkylamine Nitrosation
- (2023) Ian W. Ashworth et al. Organic Process Research & Development
- A comprehensive review of sources of nitrosamine contamination of pharmaceutical substances and products
- (2023) Harshita Akkaraju et al. REGULATORY TOXICOLOGY AND PHARMACOLOGY
- Revisiting the mutagenicity and genotoxicity of N-nitroso propranolol in bacterial and human in vitro assays
- (2023) Xilin Li et al. REGULATORY TOXICOLOGY AND PHARMACOLOGY
- N-nitrosamine Mitigation with Nitrite Scavengers in Oral Pharmaceutical Drug Products
- (2023) Anne-Cécile V. Bayne et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Nitrites as precursors of N-nitrosation in pharmaceutical samples – A trace level analysis
- (2022) Jakub Jireš et al. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
- Avoiding N-nitrosodimethylamine formation in metformin pharmaceuticals by limiting dimethylamine and nitrite
- (2022) Joerg Schlingemann 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
- N-Nitrosation in the absence of nitrosating agents in pharmaceuticals?
- (2022) Jakub Jireš et al. JOURNAL OF PHARMACEUTICAL AND BIOMEDICAL ANALYSIS
- Trace Aldehydes in Solid Oral Dosage Forms as Catalysts for Nitrosating Secondary Amines
- (2022) Paul Harmon JOURNAL OF PHARMACEUTICAL SCIENCES
- 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
- Ranitidine: A Proposed Mechanistic Rationale for NDMA Formation and a Potential Control Strategy
- (2022) Paul Harmon JOURNAL OF PHARMACEUTICAL SCIENCES
- Assessment of a Diverse Array of Nitrite Scavengers in Solution and Solid State: A Study of Inhibitory Effect on the Formation of Alkyl-Aryl and Dialkyl N-Nitrosamine Derivatives
- (2022) Miha Homšak et al. Processes
- Critical Analysis of Drug Product Recalls due to Nitrosamine Impurities
- (2021) Sonali S. Bharate JOURNAL OF MEDICINAL CHEMISTRY
- Nitrosamine formation from the reaction of methamphetamine with gaseous nitrous acid
- (2021) Alexandra Mayer et al. Drug Testing and Analysis
- Prediction of N-Nitrosamine Partition Coefficients for Derisking Drug Substance Manufacturing Processes
- (2021) Ian W. Ashworth et al. ORGANIC PROCESS RESEARCH & DEVELOPMENT
- Effect of Oral Ranitidine on Urinary Excretion of N-Nitrosodimethylamine (NDMA)
- (2021) Jeffry Florian et al. JAMA-JOURNAL OF THE AMERICAN MEDICAL ASSOCIATION
- Inhibition of N-Nitrosamine Formation in Drug Products: A Model Study
- (2021) Kausik K. Nanda et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- NDMA analytics in metformin products: Comparison of methods and pitfalls
- (2021) Matthias Fritzsche et al. EUROPEAN JOURNAL OF PHARMACEUTICAL SCIENCES
- A Novel Testing Approach for Oxidative Degradation Dependent Incompatibility of Amine Moiety Containing Drugs with PEGs in Solid-State
- (2020) Blaž Robnik et al. Pharmaceutics
- Controlling a Cohort: Use of Mirabilis-Based Purge Calculations to Understand Nitrosamine-Related Risk and Control Strategy Options
- (2020) Michael J. Burns et al. ORGANIC PROCESS RESEARCH & DEVELOPMENT
- 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
- Formation and inhibition of N-nitrosodiethanolamine in cosmetics under pH, temperature, and fluorescent, ultraviolet, and visual light
- (2018) Duck Soo Lim et al. JOURNAL OF TOXICOLOGY AND ENVIRONMENTAL HEALTH-PART A-CURRENT ISSUES
- The Nitrite-Scavenging Properties of Catechol, Resorcinol, and Hydroquinone: A Comparative Study on Their Nitration and Nitrosation Reactions
- (2016) Yunhao Lu et al. JOURNAL OF FOOD SCIENCE
- Maillard Degradation Pathways of Vitamin C
- (2013) Mareen Smuda et al. ANGEWANDTE CHEMIE-INTERNATIONAL EDITION
- The Mechanism of Hydrolysis of Aryldiazonium Ions Revisited: Marcus Theory vs. Canonical Variational Transition State Theory
- (2013) Antonio García Martínez et al. EUROPEAN JOURNAL OF ORGANIC CHEMISTRY
- Measurement of Nitrosamine and Nitramine Formation from NOx Reactions with Amines during Amine-Based Carbon Dioxide Capture for Postcombustion Carbon Sequestration
- (2012) Ning Dai et al. ENVIRONMENTAL SCIENCE & TECHNOLOGY
- Formation of Reactive Impurities in Aqueous and Neat Polyethylene Glycol 400 and Effects of Antioxidants and Oxidation Inducers
- (2012) Jeffrey N. Hemenway et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Impact of Excipient Interactions on Solid Dosage Form Stability
- (2012) Ajit S. Narang et al. PHARMACEUTICAL RESEARCH
- Reactive Impurities in Excipients: Profiling, Identification and Mitigation of Drug–Excipient Incompatibility
- (2011) Yongmei Wu et al. AAPS PHARMSCITECH
- The Medicinal Chemist’s Toolbox: An Analysis of Reactions Used in the Pursuit of Drug Candidates
- (2011) Stephen D. Roughley et al. JOURNAL OF MEDICINAL CHEMISTRY
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