米卡芬净钠质量的傅里叶变换近红外光谱法

FTNIR Spectrometry of Micafungin Sodium Quality.

作者信息

Isaacs James T, Almeter Philip J, Henderson Bradley S, Hunter Aaron N, Platt Thomas L, Lodder Robert A

机构信息

Department of Pharmacy Services, University of Kentucky, Lexington, KY 40536.

Pharmacy Practice & Sciences, College of Pharmacy, University of Kentucky, Lexington, KY 40506.

出版信息

Contact Context. 2022;2022. doi: 10.6084/m9.figshare.19071704. Epub 2022 Jan 26.

DOI:10.6084/m9.figshare.19071704

PMID:35360460

原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC8966979/

Abstract

Intra-lot and inter-lot variability in the spectra of micafungin was detected in the Drug Quality Study (DQS) using Fourier transform near-infrared spectrometry (FTNIR). Two vials of 6 vials sampled from Fresenius Kabi lot ACP106 appeared 7.9 and 14.0 standard deviations (SDs) from the center of the rest of the vials on the DQS FTNIR screening assay. Spectra of 48 vials from 7 lots in the library showed 2 outliers at 8.3 and 9.8 SDs from the center of the rest of the library, suggesting they represent different material.

摘要

在药品质量研究（DQS）中，使用傅里叶变换近红外光谱法（FTNIR）检测了米卡芬净光谱中的批次内和批次间变异性。从费森尤斯卡比批次ACP106中抽取的6个小瓶中的2个小瓶，在DQS FTNIR筛选试验中，其光谱与其余小瓶中心的偏差分别为7.9和14.0个标准差（SD）。文库中7个批次的48个小瓶的光谱显示，有2个异常值与文库其余部分中心的偏差分别为8.3和9.8个标准差，表明它们代表不同的物质。