Research map: An Analytical Quality by Design-guided method development for the quantification of N-nitroso-fluoxetine to support mitigation strategies for a fluoxetine drug product
Back to the article
Papers in this map
White Analytical Chemistry: An approach to reconcile the principles of Green Analytical Chemistry and functionality
· Paweł Mateusz Nowak · 2021 · 1300 citations · Cited by this paper
Rapid quality evaluation of MXQLM based on bionic sensory and mathematical separation
· 2026 · Related
Quality by design in pharmaceutical manufacturing: A systematic review of current status, challenges and future perspectives
· Helena Bigares Grangeia · 2019 · 258 citations · Cited by this paper
Identification of related substances in baloxavir marboxil using 2D-LC-Q-TOF/MS
· 2026 · Related
A Nitrite Excipient Database: A Useful Tool to Support N-Nitrosamine Risk Assessments for Drug Products
· Ruth Boetzel · 2022 · 110 citations · Cited by this paper
Biomimetic chromatographic descriptors for modeling therapeutic, toxic, and lethal blood concentration endpoints: convergence with conventional physicochemical properties
· 2026 · Related
Simultaneous determination of volatile and non-volatile nitrosamines in processed meat products by liquid chromatography tandem mass spectrometry using atmospheric pressure chemical ionisation and electrospray ionisation
· Susan Strange Herrmann · 2014 · 94 citations · Cited by this paper
Optimization and clinical validation of a simplified workflow for renin-angiotensin-aldosterone system hormones and adrenal steroids: Addressing pre-analytical variability and operational efficiency
· 2026 · Related
Determining recommended acceptable intake limits for N-nitrosamine impurities in pharmaceuticals: Development and application of the Carcinogenic Potency Categorization Approach (CPCA)
· Naomi L. Kruhlak · 2024 · 89 citations · Cited by this paper
Differential impedimetric sensing of arboviruses using a lectin-modified hybrid polypyrrole-gold nanoparticle platform
· 2026 · Related
A comprehensive review of sources of nitrosamine contamination of pharmaceutical substances and products
· Harshita Akkaraju · 2023 · 82 citations · Cited by this paper
Oxidative degradation of melatonin in solution and solid-state pharmaceutical blends: HPLC-HRMS/MS degradant characterization, metal-mediated acceleration and EDTA mitigation
· 2026 · Related
Analytical lifecycle management for comprehensive and universal nitrosamine analysis in various pharmaceutical formulations by supercritical fluid chromatography
· Sebastian Schmidtsdorff · 2021 · 33 citations · Cited by this paper
Decoding thermal instability in peptide therapeutics links microheterogeneity to bioactivity loss
· 2026 · Related
Simultaneous determination of 13 nitrosamine impurities in biological medicines using salting-out liquid-liquid extraction coupled with liquid chromatography tandem mass spectrometry
· Feifei Luo · 2022 · 21 citations · Cited by this paper
Solvent compatibility for extractables analysis of silicones
· 2026 · Related
The quality of drugs and drug products – Always guaranteed?
· Helmut Buschmann · 2023 · 19 citations · Cited by this paper
A chemiluminescence immunosensor for the detection of erythrocyte folate using specific monoclonal antibodies
· 2026 · Related
Comprehensive UHPLC–MS screening methods for the analysis of triazolopyrazine precursor and its genotoxic nitroso-derivative in sitagliptin pharmaceutical formulation
· Jakub Jireš · 2023 · 13 citations · Cited by this paper
Biosensing technologies for cannabinoid monitoring in pain management: Current methods, clinical needs, and translational challenges
· 2026 · Related
Investigation into the genotoxic impurity, 1-methyl-4-nitrosopiperazine, in rifampicin
· Ye Tian · 2024 · 6 citations · Cited by this paper
Nitrosamine drug substance-related impurities cause DNA methylation adducts in vitro and in primary hepatocytes upon Cytochrome P450-dependend metabolic activation
· Matthias Vogel · 2026 · 4 citations · Cited by this paper
A case study on N-nitrosamine investigation in a marketed drug: from analytical procedure validation to risk mitigation decision
· Yue Zhang · 2026 · 1 citation · Cited by this paper
Source: OpenAlex (CC0)