Abstract
Abstract To assess the stability of Larotrectinib sulfate under the stress conditions, according to ICH guideline Q1A (R2). Majorly one unknown thermal degradation impurity was formed, which was separated on a C-18 column, using gradient elution and identified by LCMS, found at relative retention time 0.58. This impurity was isolated using preparative high performance liquid chromatography, and characterized by 1H NMR, 13C NMR, MS, HR-MS and FT-IR experiments. Isolated impurity was showing molecular weight of 508.13, molecular formula of C21H22F2N6O5S and its chemical name as(2,5-difluorophenyl)pyrrolidin-1-yl)pyrazolo[1,5-a]pyrimidin3yl)carbamoyl) pyrrolidin-3-yl hydrogen sulfate. The details of stress studies, identification, isolation, characterization, formation and its mechanism of this impurity is discussed and presented in detail.
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