ArticleRSC advances2022
A rapid and sensitive UPLC-MS/MS method for simultaneous determination of four potential mutagenic impurities at trace levels in ripretinib drug substance.
Article in RSC advances, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.
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Who cites it
2 citing papers in PubMed, 5 citations in OpenAlex.
- Liquid chromatography-tandem mass spectrometry for the quantification of ripretinib and its metabolites DP-5439 in human plasma.Frontiers in pharmacology · 2024Article
- Effect of Verapamil, a P-glycoprotein-1 and Cytochrome P450 3A4 Inhibitor, on Pharmacokinetics and Metabolic Stability of Ripretinib: A Drug-Drug Interaction Study in Rats.European journal of drug metabolism and pharmacokinetics · 2023Article
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Authors and funding
5 authors at 2 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
In the synthesis of ripretinib, a new oral tyrosine kinase inhibitor, impurities could arise directly from starting materials, reagents and intermediates. Among these process impurities, four specific intermediate impurities were found to contain the structural alerts of primary aromatic amine and aldehyde groups, triggering the concern of potential mutagenic impurities (PMIs). Two complementary (quantitative) structure-activity relationship [(Q)SAR] evaluation systems (expert rule-based and statistics-based) were subsequently employed to assess and classify the mutagenic risk of the four known impurities. The Sarah prediction results of these four impurities were all positive and they were categorized as class 3, where the threshold of toxicological concern (TTC) of 1.5 μg d
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Registered trials
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