Approaches and Considerations for the Investigation and Synthesis of N-Nitrosamine Drug Substance-Related Impurities (NDSRIs)
出版年份 2023 全文链接
标题
Approaches and Considerations for the Investigation and Synthesis of N-Nitrosamine Drug Substance-Related Impurities (NDSRIs)
作者
关键词
-
出版物
Organic Process Research & Development
Volume -, Issue -, Pages -
出版商
American Chemical Society (ACS)
发表日期
2023-05-30
DOI
10.1021/acs.oprd.3c00084
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
- N-Nitrosamine Formation in Pharmaceutical Solid Drug Products: Experimental Observations
- (2023) Justin Moser et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- Modified NAP test: A simple and Responsive Nitrosating Methodology for Risk Evaluation of NDSRIs
- (2023) Nitish Sharma et al. JOURNAL OF PHARMACEUTICAL SCIENCES
- 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
- 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
- Rh(III)‐Catalyzed C−H Functionalization of N‐ Nitrosoanilines with α ‐Sulfonylcarbenes
- (2022) Rui‐jun Peng et al. ADVANCED SYNTHESIS & CATALYSIS
- What Makes a Potent Nitrosamine? Statistical Validation of Expert-Derived Structure–Activity Relationships
- (2022) Robert Thomas et al. CHEMICAL RESEARCH IN TOXICOLOGY
- Strategies for Assessing Acceptable Intakes for Novel N-Nitrosamines Derived from Active Pharmaceutical Ingredients
- (2022) David J. Ponting et al. Journal of Medicinal Chemistry
- The Landscape of Potential Small and Drug Substance Related Nitrosamines in Pharmaceuticals
- (2022) Joerg Schlingemann 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
- Are all nitrosamines concerning? A review of mutagenicity and carcinogenicity data
- (2020) Andrew Thresher et al. REGULATORY TOXICOLOGY AND PHARMACOLOGY
- An efficient synthesis of N-nitrosamines under solvent, metal and acid free conditions using tert-butyl nitrite
- (2016) Priyanka Chaudhary et al. GREEN CHEMISTRY
- Reduction of N-Nitrosaminoquinolinediones with LiAlH4- an Easy Path to New Tricyclic Benzoxadiazocines
- (2016) Antonín Klásek et al. HELVETICA CHIMICA ACTA
- Tunable Push–Pull Interactions in 5-Nitrosopyrimidines
- (2016) Eliška Procházková et al. JOURNAL OF ORGANIC CHEMISTRY
- Oxidative Ring Expansion of Spirocyclic Oxindole Derivatives
- (2014) Jan Bergman et al. JOURNAL OF ORGANIC CHEMISTRY
- Accurate Rate Constants for Decomposition of Aqueous Nitrous Acid
- (2012) Mark S. Rayson et al. INORGANIC CHEMISTRY
- Rhodium(III)-Catalyzed N-Nitroso-Directed C–H Olefination of Arenes. High-Yield, Versatile Coupling under Mild Conditions
- (2012) Baoqing Liu et al. JOURNAL OF THE AMERICAN CHEMICAL SOCIETY
Add your recorded webinar
Do you already have a recorded webinar? Grow your audience and get more views by easily listing your recording on Peeref.
Upload NowCreate your own webinar
Interested in hosting your own webinar? Check the schedule and propose your idea to the Peeref Content Team.
Create Now