کد مقاله | کد نشریه | سال انتشار | مقاله انگلیسی | نسخه تمام متن |
---|---|---|---|---|
7632505 | 1494663 | 2012 | 10 صفحه PDF | دانلود رایگان |
عنوان انگلیسی مقاله ISI
Monitoring batch-to-batch reproducibility of liquid-liquid extraction process using in-line near-infrared spectroscopy combined with multivariate analysis
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کلمات کلیدی
CQATCMMPLSMSPCAOCLiquid–liquid extraction - استخراج مایع مایعMultivariate data analysis - تجزیه و تحلیل داده های چند متغیرهProcess analytical technology - تکنولوژی تحلیلی فرایندMulti-way partial least squares - حداقل مربعات جزئی چند طرفهNOC - شبtraditional Chinese medicine - طب سنتی چینیTraditional Chinese medicine (TCM) - طب سنتی چینی (TCM)Near-infrared (NIR) spectroscopy - طیف سنجی نزدیک مادون قرمز (NIR)Batch process monitoring - نظارت بر فرآیند دسته ایCritical quality attribute - ویژگی کیفی بحرانیpat - پاتMultivariate statistical process control - کنترل فرآیند آماری چند متغیره
موضوعات مرتبط
مهندسی و علوم پایه
شیمی
شیمی آنالیزی یا شیمی تجزیه
پیش نمایش صفحه اول مقاله
چکیده انگلیسی
Traditional Chinese medicine (TCM) products are usually manufactured through batch processes. To improve batch-to-batch reproducibility, the feasible approaches for real-time monitoring of batch evolution need to be developed. In-line near-infrared (NIR) spectroscopy combined with multivariate data analysis as an efficient process analytical technology (PAT) tool, is presented in this study for real-time batch process monitoring. Liquid-liquid extraction is a widely used purification technology in the TCM manufacture, and selected as the example to demonstrate the effectiveness of this PAT tool. Multi-way partial least squares (MPLS) model was developed based on in-line measured NIR spectral data of ten normal operation condition (NOC) batches. Three kinds of multivariate control charts (scores, Hotelling T2 and DModX) were used to monitor the evolution of six test batches with artificial batch variations, including the change of starting material quality attributes and abnormal operation conditions. The approach was found very effective for real-time monitoring of process deviations from NOC batches. It is an alternative promising tool for monitoring batch reproducibility of the unit operations during the manufacture of TCM.
ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 70, November 2012, Pages 178-187
Journal: Journal of Pharmaceutical and Biomedical Analysis - Volume 70, November 2012, Pages 178-187
نویسندگان
Haoshu Xiong, Xingchu Gong, Haibin Qu,