ArticleRSC advances2025
Development and validation of a method for quantitative determination of the genotoxic impurity diethyl sulfate in pitolisant hydrochloride
Article in RSC advances, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 1 paper.
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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.
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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
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Authors and funding
6 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
A simple and highly sensitive method was devised to detect and measure minute concentrations of diethyl sulfate (DES), a potential genotoxic impurity found in the active pharmaceutical ingredients of pitolisant hydrochloride. High-performance liquid chromatography (HPLC) was employed to accurately quantify this impurity, involving pre-column derivatization with sodium phenoxide. Chromatographic separation was achieved using a Shim-pack C18 column (250 × 4.6 mm ID × 5 μ), with a mobile phase composed of 0.01 M sodium dihydrogen orthophosphate in water (mobile phase A) and acetonitrile (mobile phase B) in a gradient elution mode at a flow rate of 1.5 mL min
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Registered trials
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