Real-Time Release Testing of Herbal Extract Powder by Near-Infrared Spectroscopy considering the Uncertainty around Specification Limits
Joint Authors
Shi, Xinyuan
Wang, Xin
Shi, Guolin
Xu, Bing
Xue, Zhong
Qiao, Yanjiang
Source
Issue
Vol. 2019, Issue 2019 (31 Dec. 2019), pp.1-10, 10 p.
Publisher
Hindawi Publishing Corporation
Publication Date
2019-03-03
Country of Publication
Egypt
No. of Pages
10
Main Subjects
Abstract 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.
American Psychological Association (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
Modern Language Association (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
American Medical Association (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
Data Type
Journal Articles
Language
English
Notes
Includes bibliographical references
Record ID
BIM-1192034