Isaacs James T, Almeter Philip J, Henderson Bradley S, Hunter Aaron N, Platt Thomas L, Lodder Robert A
Contact Context. 2022;2022. doi: 10.6084/m9.figshare.18316523. Epub 2022 Apr 12.
Intra-lot and inter-lot variability in the spectra of levothyroxine was detected in the Drug Quality Study (DQS) using Fourier transform near-infrared spectrometry (FTNIR). Two vials of 12 vials sampled from Athenex lot AFN102 appeared 10.1 and 9.1 SDs from the center of the rest of the vials on the DQS FTNIR screening assay. Spectra of 108 vials from six lots in the library clustered in two groups (p=0.02), suggesting they represent different material.
在药物质量研究（DQS）中，使用傅里叶变换近红外光谱法（FTNIR）检测到左甲状腺素光谱中的批次内和批次间变异性。从阿塞尼克斯批次AFN102中抽取的12瓶样品中的2瓶，在DQS FTNIR筛选试验中，其光谱与其余样品瓶中心的偏差分别为10.1和9.1个标准差。文库中来自六个批次的108瓶样品的光谱聚为两组（p = 0.02），表明它们代表不同的物质。
