达卡巴嗪工艺变化的光谱分析结果。

Contact in context Pub Date : 2022-01-01 Epub Date: 2022-01-04 DOI:10.6084/m9.figshare.17868614
James T Isaacs, Philip J Almeter, Bradley S Henderson, Aaron N Hunter, Thomas L Platt, Robert A Lodder
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引用次数: 1

摘要

在药品质量研究(DQS)中,采用傅里叶变换近红外光谱法(FTNIR)检测达卡巴嗪的批次内和批次间变异。在DQS FTNIR筛选试验中,从费森尤斯卡比批次6125612取样的6个小瓶中,有1个小瓶从其余小瓶的中心出现7.8个SDs。文库中6批54个小瓶的光谱聚为两组(p=0.02),表明它们代表不同的物质。
本文章由计算机程序翻译,如有差异,请以英文原文为准。

Spectrometric Results of Process Variations in Dacarbazine.

Spectrometric Results of Process Variations in Dacarbazine.

Intra-lot and inter-lot variability in dacarbazine was detected in the Drug Quality Study (DQS) using Fourier transform near-infrared spectrometry (FTNIR). One vial of six vials sampled from Fresenius Kabi Lot 6125612 appeared 7.8 SDs from the center of the rest of the vials on the DQS FTNIR screening assay. Spectra of 54 vials from six lots in the library clustered in two groups (p=0.02), suggesting they represent different material.

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