Division of Pharmaceutical Analysis, Center for Drug Evaluation and Research, US Food and Drug Administration, Saint Louis, MO 63101, USA.
Appl Spectrosc. 2012 Nov;66(11):1262-8. doi: 10.1366/11-06572.
A deep-ultraviolet (UV) Raman spectrometer with excitation source tunable from 193 to 210 nm has been built and characterized. The dispersion of the spectrometer over the entire range was measured and described theoretically. The relative sensitivity of the spectrometer was estimated using the integrated intensity ratio of two Raman bands of cyclohexane. Resonance Raman spectra of three formulated insulin products were measured and compared. A band-targeted entropy minimization algorithm was applied to the collected spectra for mixture analysis of insulin products. We conclude that it is feasible to develop robust qualitative methods for quality control of protein-based formulated drug using DUVRR spectroscopy.
已构建并表征了一台激发源可调谐范围从 193nm 到 210nm 的深紫外（UV）拉曼光谱仪。测量了光谱仪在整个范围内的色散，并从理论上进行了描述。使用环己烷两个拉曼带的积分强度比估算了光谱仪的相对灵敏度。测量并比较了三种配方胰岛素产品的共振拉曼光谱。对采集的光谱应用带目标熵最小化算法进行胰岛素产品的混合物分析。我们得出结论，使用 DUVRR 光谱法开发用于基于蛋白质的配方药物的稳健定性质量控制方法是可行的。
