ReviewSaudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society2023
An update on the current status and prospects of nitrosation pathways and possible root causes of nitrosamine formation in various pharmaceuticals.
Review in Saudi pharmaceutical journal : SPJ : the official publication of the Saudi Pharmaceutical Society, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 18 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
18 citing papers in PubMed, 69 citations in OpenAlex.
- Impurity Characterization Across Drug Development Stages: Analytical Methodologies and Regulatory Perspectives.Pharmaceutical research · 2026Review
- Complex versus simpleScience advances · 2026Article
- Determination of Nitrosamine Drug Substance-Related Impurities Derived from Nortriptyline and Sertraline Using LC-MS/MS: A Comparative Evaluation of Chromatographic Separation and Pharmaceutical Application.Pharmaceuticals (Basel, Switzerland) · 2025Article
- Genotoxicity evaluation of ten nitrosamine drug substance-related impurities using 2D and 3D HepaRG cell models.Regulatory toxicology and pharmacology : RTP · 2025Article
- Current progress of 1,2,3-triazole hybrids as EGFR inhibitors for cancer therapy - a literature review.RSC advances · 2025Review
- Computational mechanistic study on N-nitrosation reaction of secondary amines.Journal of molecular modeling · 2025Article
- Regulatory role of N-nitroso compounds and lncRNA NEAT1 in endoplasmic reticulum stress and malignant transformation of gastric epithelial cells.Cancer cell international · 2025Article
- Colorimetric Detection of Nitrosamines in Human Serum Albumin Using Cysteine-Capped Gold Nanoparticles.Sensors (Basel, Switzerland) · 2025Article
- LC-ESI-HRMS-Based Evaluation of Antioxidants as Additives to Inhibit Genotoxic Nitrosamine Formation in Metformin Hydrochloride Tablets.AAPS PharmSciTech · 2025Article
- Molecular and Biochemical Mechanisms of Cardiomyopathy Development Following Prenatal Hypoxia-Focus on the NO System.Antioxidants (Basel, Switzerland) · 2025Review
- Green and sustainable LC-APCI-MS/MS method for simultaneous quantification of genotoxic nitrosamines in antidiabetic medication: sitagliptin.BMC chemistry · 2025Article
- Nitrosamine Drug Substance-Related Impurities (NDSRIs) in Pharmaceuticals: Formation, Mitigation Strategies, and Emphasis on Mutagenicity Risks.Pharmaceutical research · 2025Review
- Advancements of paper-based microfluidics and organ-on-a-chip models in cosmetics hazards.RSC advances · 2025Review
- The Presence of Nitrosamines and Nitrosamine Drug-Related Substances in Pharmaceutical Products: An Overview of Regulatory Concerns, Analytical Methodologies, and Control Strategies.Current drug safety · 2025Review
- Optimizing the detection of N-nitrosamine mutagenicity in the Ames test.Regulatory toxicology and pharmacology : RTP · 2024Article
- N-Nitrosodimethylamine investigations in Muta™Mouse define point-of-departure values and demonstrate less-than-additive somatic mutant frequency accumulations.Mutagenesis · 2024Article
- Patient In-Use Stability Testing of FDA-Approved Metformin Combination Products for N-Nitrosamine Impurity.AAPS PharmSciTech · 2024Article
- Nitrosamine Impurities in Pharmaceuticals: An Empirical Review of their Detection, Mechanisms, and Regulatory Approaches.Current topics in medicinal chemistry · 2024Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
4 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Over the last two years, global regulatory authorities have raised safety concerns on nitrosamine contamination in several drug classes, including angiotensin II receptor antagonists, histamine-2 receptor antagonists, antimicrobial agents, and antidiabetic drugs. To avoid carcinogenic and mutagenic effects in patients relying on these medications, authorities have established specific guidelines in risk assessment scenarios and proposed control limits for nitrosamine impurities in pharmaceuticals. In this review, nitrosation pathways and possible root causes of nitrosamine formation in pharmaceuticals are discussed. The control limits of nitrosamine impurities in pharmaceuticals proposed by national regulatory authorities are presented. Additionally, a practical and science-based strategy for implementing the well-established control limits is notably reviewed in terms of an alternative approach for drug product
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What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.