Real-Time Release Testing of Herbal Extract Powder by Near-Infrared Spectroscopy considering the Uncertainty around Specification Limits
المؤلفون المشاركون
Shi, Xinyuan
Wang, Xin
Shi, Guolin
Xu, Bing
Xue, Zhong
Qiao, Yanjiang
المصدر
العدد
المجلد 2019، العدد 2019 (31 ديسمبر/كانون الأول 2019)، ص ص. 1-10، 10ص.
الناشر
Hindawi Publishing Corporation
تاريخ النشر
2019-03-03
دولة النشر
مصر
عدد الصفحات
10
التخصصات الرئيسية
الملخص EN
The concept of real-time release testing (RTRT) has recently been adopted by the production of pharmaceuticals in order to provide high-level guarantee of product quality.
Process analytical technology (PAT) is an attractive and efficient way for realizing RTRT.
In this paper, near-infrared (NIR) determination of cryptotanshinone and tanshinoneIIA content in tanshinone extract powders was taken as the research object.
The aim of NIR analysis is to reliably declare the extract product as compliant with its specification limits or not.
First, the NIR quantification method was developed and the parameters of the multivariate calibration model were optimized.
The reliable concentration ranges covering the specification limits of two APIs were successfully verified by the accuracy profile (AP) methodology.
Then, with the designed validation data from AP, the unreliability graph as the decision tool was built.
Innovatively, the β-content, γ-confidence tolerance intervals (β-CTIs) around the specification limits were estimated.
During routine use, the boundary of β-CTIs could help decide whether the NIR prediction results are acceptable.
The proposed method quantified the analysis risk near the specification limits and confirmed that the unreliable region was useful to release the product quality in a real-time way.
Such release strategy could be extended for other PAT applications to improve the reliability of results.
نمط استشهاد جمعية علماء النفس الأمريكية (APA)
Shi, Guolin& Xu, Bing& Wang, Xin& Xue, Zhong& Shi, Xinyuan& Qiao, Yanjiang. 2019. Real-Time Release Testing of Herbal Extract Powder by Near-Infrared Spectroscopy considering the Uncertainty around Specification Limits. Journal of Spectroscopy،Vol. 2019, no. 2019, pp.1-10.
https://search.emarefa.net/detail/BIM-1192034
نمط استشهاد الجمعية الأمريكية للغات الحديثة (MLA)
Shi, Guolin…[et al.]. Real-Time Release Testing of Herbal Extract Powder by Near-Infrared Spectroscopy considering the Uncertainty around Specification Limits. Journal of Spectroscopy No. 2019 (2019), pp.1-10.
https://search.emarefa.net/detail/BIM-1192034
نمط استشهاد الجمعية الطبية الأمريكية (AMA)
Shi, Guolin& Xu, Bing& Wang, Xin& Xue, Zhong& Shi, Xinyuan& Qiao, Yanjiang. Real-Time Release Testing of Herbal Extract Powder by Near-Infrared Spectroscopy considering the Uncertainty around Specification Limits. Journal of Spectroscopy. 2019. Vol. 2019, no. 2019, pp.1-10.
https://search.emarefa.net/detail/BIM-1192034
نوع البيانات
مقالات
لغة النص
الإنجليزية
الملاحظات
Includes bibliographical references
رقم السجل
BIM-1192034
قاعدة معامل التأثير والاستشهادات المرجعية العربي "ارسيف Arcif"
أضخم قاعدة بيانات عربية للاستشهادات المرجعية للمجلات العلمية المحكمة الصادرة في العالم العربي
تقوم هذه الخدمة بالتحقق من التشابه أو الانتحال في الأبحاث والمقالات العلمية والأطروحات الجامعية والكتب والأبحاث باللغة العربية، وتحديد درجة التشابه أو أصالة الأعمال البحثية وحماية ملكيتها الفكرية. تعرف اكثر