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Evaluation of the Genotoxic Impurities of Selpercatinib Through HPLC and LC-MS/MS Identification of Selpercatinib Stress Degradation Products
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Evaluation of the Genotoxic Impurities of Selpercatinib Through HPLC and LC-MS/MS Identification of Selpercatinib Stress Degradation Products
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Evaluation of the Genotoxic Impurities of Selpercatinib Through HPLC and LC-MS/MS Identification of Selpercatinib Stress Degradation Products
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Journal Article
Evaluation of the Genotoxic Impurities of Selpercatinib Through HPLC and LC-MS/MS Identification of Selpercatinib Stress Degradation Products
2024
Overview
[...]this approach can be appropriate for the resolution and quantification of genotoxic impurities in selpercatinib and can also be applicable for the evaluation of stress degradation products. Existing literature indicates a lack of reported analytical methods for quantifying genotoxic impurities in selpercatinib, and no author has characterized the stress degradation compounds of selpercatinib. [...]this paper introduces an optimized HPLC method for quantifying genotoxic impurities of selpercatinib and LC-MS/MS characterization of degradation products (DPs). Method Validation The guidelines prescribed by ICH (ICH 1994; ICH 1996; ICH 2003) and authors reported in literature were utilized for conducting validation study of the proposed method (Varma et al., 2022; Rajesh et al., 2022; Varma et al., 2023; & Rajesh et al., 2023). The method sensitivity for detecting the targeted impurities underwent rigorous assessment employing the signal-to-noise (S/N) ratio procedure.
