ReviewTherapeutic innovation & regulatory science2026
Impurities in Oncology Pharmaceuticals: A Review of Classification, Detection Methods, Regulatory Frameworks and Emerging Trends.
Review in Therapeutic innovation & regulatory science, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
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.
Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.
Who cites it
1 citing paper in PubMed.
- From "Undetectable" to "Sensitive Detection": Advances in Derivatization Techniques for LC-MS Analysis of Genotoxic Impurities.Molecules (Basel, Switzerland) · 2026Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
3 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Pharmaceutical impurities pose a significant challenge in the development and manufacturing of anti-cancer drugs due to their high potency, narrow therapeutic index, and prolonged administration in most treatment regimens. Even trace-level impurities can compromise drug safety, efficacy, and regulatory compliance. This review provides a comprehensive overview of various types of pharmaceutical impurities organic, inorganic, residual solvents, and genotoxic impurities with a focus on their origins, toxicological significance, and impact on oncology therapeutics. The paper discusses traditional and modern analytical methods used for impurity detection, including chromatographic techniques, spectroscopic tools, mass spectrometry, and capillary electrophoresis and advanced hyphenated systems. Regulatory frameworks from International Council for Harmonization, the U.S. Food and Drug Administration, the European Medicines Agency, Therapeutic Goods Administration, Medicines and Healthcare products Regulatory Agency and the World Health Organization are examined, particularly concerning acceptable limits for genotoxic and elemental impurities. In addition, this study explores recent advancements such as surface plasmon coupled emission technique, AI-assisted data analysis, portable sensors, and real-time monitoring technologies that enhance impurity profiling. The advantages and applications of the modern technologies are discussed, emphasizing their role in improving method efficiency, automation, and sustainability in connection with the impurity profiling.
Indexed as
Identifiers
41817919What 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.