Isaacs James T, Almeter Philip J, Henderson Bradley S, Hunter Aaron N, Platt Thomas L, Lodder Robert A
Department of Pharmacy Services, University of Kentucky, Lexington, KY 40536.
Pharmacy Practice & Sciences, College of Pharmacy, University of Kentucky, Lexington, KY 40506.
Contact Context. 2022;2022. doi: 10.6084/m9.figshare.20245158. Epub 2022 Jul 6.
Pemetrexed is a folate analog metabolic inhibitor used in treatment of locally advanced or metastatic nonsquamous non-small cell lung cancer and for mesothelioma. Intra-lot and inter-lot variability in the spectra of ALIMTA® was detected in the Drug Quality Study (DQS) using Fourier transform near-infrared spectrometry (FTNIR). One vial of 12 (8%) sampled from lot S20I013A appeared 3.0 multidimensional SDs from the other vials, suggesting that it represents a different material. Consequently, additional spectra from other lots were analyzed. Spectra of 147 vials from 23 lots in the spectral library contained 14 vials that were outside the main group (26.4 SDs using a subcluster detection test), suggesting that the 14 library vials (9.5% of the total) also contain differing materials.
培美曲塞是一种叶酸类似物代谢抑制剂，用于治疗局部晚期或转移性非鳞状非小细胞肺癌以及间皮瘤。在药品质量研究（DQS）中，使用傅里叶变换近红外光谱法（FTNIR）检测到了力比泰®（ALIMTA®）光谱中的批次内和批次间变异性。从批次S20I013A中抽取的12瓶中有1瓶（8%）与其他瓶相比出现了3.0个多维标准差，这表明它代表了一种不同的物质。因此，对来自其他批次的额外光谱进行了分析。光谱库中来自23个批次的147瓶的光谱包含14瓶在主要组之外（使用子聚类检测测试为26.4个标准差），这表明这14瓶库藏样品（占总数的9.5%）也含有不同的物质。
