Biomedical chromatography : BMCTandem Mass SpectrometryDrug ContaminationGas Chromatography-Mass SpectrometryReproducibility of ResultsMutagens
Validated GC-MS and LC-MS/MS Methods for ICH M7-Based Quantification of Alkyl Mesylate and Azido Genotoxic Impurities in Pharmaceutical Products.
Neşet Neşetoğlu, Durişehvar Özer Ünal
Published: 202610.1002/bmc.70357
Abstract
Genotoxic impurities (GTIs) in pharmaceutical products represent a critical safety concern because they can induce DNA damage and may lead to mutagenic and carcinogenic effects even at trace concentrations. Consequently, regulatory authorities such a…
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