【摘 要】
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Purposes of this study are to monitor a polymorphic transformation process through in-line NIR measurements and concurrently to quantify the whole process with off-line reference analysis.The solvent-
【机 构】
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Department of Smart Foods and Drugs Inje University,Gimhae,Gyeongnam 621-749,South Korea
【出 处】
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The 6th International Conference on Separation and Technolog
论文部分内容阅读
Purposes of this study are to monitor a polymorphic transformation process through in-line NIR measurements and concurrently to quantify the whole process with off-line reference analysis.The solvent-mediated phase transformation (SMPT) behavior of sulfamerazine (SMZ) from meta-stable form-I to stable form-II was visualized by principal component analysis (PCA) and quantified using PLS-based correlation.The most distinct NIR spectral differences between two SMZ polymorphs occurred in the wavenumber of 7500-4900 em-1.NIR spectra acquired in this range were pre-treated and analyzed by chemometrics tool.Samples taken at each hour from the start to 10 hours went through various instrumental analyses such as SEM,XRD,and DSC for calibration modeling.Experimental results indicated that the SMPT to form-Ⅱ was completed within 8 hours.According to PCA,99% of the spectral variation was associated with the effect of PC1.In-line NIR spectra and off-line characterization data were correlated very well.In brief,in-line NIR monitoring can be performed as a very powerful and effective analytical tool not only to identify polymorphie conversion but to predict the critical quality attributes (CQA),such as polymorphism,crystal size,crystal size distribution,and nucleation during a SMPT process.Research results will be presented in detail for discussion.
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