Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies
出版年份 2023 全文链接
标题
Formation of N-Nitrosamine Drug Substance Related Impurities in Medicines: A Regulatory Perspective on Risk Factors and Mitigation Strategies
作者
关键词
-
出版物
ORGANIC PROCESS RESEARCH & DEVELOPMENT
Volume 27, Issue 10, Pages 1736-1750
出版商
American Chemical Society (ACS)
发表日期
2023-07-21
DOI
10.1021/acs.oprd.3c00153
参考文献
相关参考文献
注意:仅列出部分参考文献,下载原文获取全部文献信息。- 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
- (2023) Bodin Tuesuwan et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- N-Nitrosamine Formation in Pharmaceutical Solid Drug Products: Experimental Observations
- (2023) Justin Moser et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Nitrosated active pharmaceutical ingredients – lessons learned?
- (2023) U. Holzgrabe JOURNAL OF PHARMACEUTICAL SCIENCES
- 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
Find Funding. Review Successful Grants.
Explore over 25,000 new funding opportunities and over 6,000,000 successful grants.
ExploreCreate your own webinar
Interested in hosting your own webinar? Check the schedule and propose your idea to the Peeref Content Team.
Create Now