Betrixaban Maleate, a novel oral, once-daily factor Xa inhibitor drug substance, was subjected to stress testing under a wide range of degradation conditions, including acidic hydrolysis, alkaline hydrolysis, oxidative, thermal, and photolytic, to determine its inherent stability. The drug was biodegradable in acidic and alkaline environments, and three new degradation products were identified. Two degraded products are formed in an acidic environment, while the third is in alkaline conditions. The three degradants were identified using UPLC-ESI/MS and isolated using mass-triggered preparative HPLC, and their structures were unambiguously elucidated using HRMS and ²D NMR techniques. Based on spectral and chromatographic data, it was firmly proven that these distinct degradation products were the betrixaban chemical's hydrolysis components. The formation of the degradants has been hypothesized through several possible mechanisms.

Betrixaban Maleate 是一种新型口服、每日一次的 Xa 因子抑制剂药物，在多种降解条件下进行了压力测试，包括酸性水解、碱性水解、氧化、热和光解，以确定其固有稳定性。该药物在酸性和碱性环境中可生物降解，并鉴定出三种新的降解产物。在酸性环境下会形成两种降解产物，而在碱性条件下会形成第三种降解产物。使用 UPLC-ESI/MS 鉴定了这三种降解物，并使用质量触发制备型 HPLC 进行分离，并使用 HRMS 和² D NMR 技术明确阐明了它们的结构。根据光谱和色谱数据，有力地证明这些不同的降解产物是贝曲西班化学品的水解成分。已经通过几种可能的机制假设了降解物的形成。