Intra-Lot and Inter-Lot Variability in Cosyntropin.

Contact in context Pub Date : 2021-01-01 Epub Date: 2021-12-22 DOI:10.6084/m9.figshare.17363048
Philip J Almeter, James T Isaacs, Aaron N Hunter, Bradley S Henderson, Robert A Lodder
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Abstract

Intra-lot and inter-lot variability in cosyntropin was detected in the DQS using Fourier transform near-infrared spectrometry. One vial of 12 sampled from Sandoz Lot0200062 appeared 6.9 SDs from the center of the rest of the vials, and another was 4.3 SDs away. Spectra of 102 vials from 7 lots in the library clustered in two groups (p=0.02).

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共syntropin的地段内和地段间变异。
采用傅立叶变换近红外光谱法检测共syntropin在DQS中的批次内和批次间变异。山德士Lot0200062的12个样品中,有一个样品瓶的中心出现6.9个SDs,另一个样品瓶的中心出现4.3个SDs。文库中7批102支样品的光谱聚为两组(p=0.02)。
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