OrbiSIMS对乳糖样品批次与表面杂质的鉴别

IF 3.3 3区化学 Q2 CHEMISTRY, ANALYTICAL

Analyst Pub Date : 2025-07-14 DOI:10.1039/d5an00364d

Bin Yan, Junting Zhang, Eleonora Paladino, Mark Nicholas, Paulina Rakowska, Anthony W.T. Bristow, Ian Gilmore

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引用次数: 0

摘要

用于给药的药物制剂表面存在的杂质严重影响其稳定性和有效性。因此，表征表面的杂质是必不可少的，以确保疗效，质量和安全。二次离子质谱（SIMS）由于其高灵敏度和空间分辨率，在制药行业的表面分析中越来越受欢迎。飞行时间（ToF） SIMS仪器已成功使用。然而，它们的应用受到限制，因为质量分辨能力和质量精度太低，无法分离复杂的峰并给出可靠的识别。OrbiSIMS仪器克服了这个问题，因为它的Orbitrap分析仪具有>的质量分辨能力；240,000在m/z 200和质量精度为<；下午2点：我们使用OrbiSIMS结合多变量分析，通过检测表面杂质的微小差异来区分来自不同供应商的名义上相同批次的乳糖。

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Differentiation of lactose sample batches from surface impurities by OrbiSIMS

Impurities present on the surface of pharmaceutical formulations for drug delivery significantly impact their stability and efficacy. Hence, the characterization of impurities on the surface is essential to ensure efficacy, quality, and safety. Secondary ion mass spectrometry (SIMS) is gaining increasing popularity for surface analysis in the pharmaceutical industry, due to its high sensitivity and spatial resolution. Time-of-Flight (ToF) SIMS instruments have been successfully used. However, their application has been limited since the mass resolving power and mass accuracy are too low to separate complex peaks and give identification with confidence. The OrbiSIMS instrument overcomes this issue owing to its Orbitrap analyzer with a mass resolving power of > 240,000 at m/z 200 and a mass accuracy of < 2 p.p.m. We use the OrbiSIMS in combination with multivariate analysis to differentiate notionally identical batches of lactose from different suppliers using the detection of small differences in surface impurities.

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