Real-Time Release Testing of Herbal Extract Powder by Near-Infrared Spectroscopy considering the Uncertainty around Specification Limits
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) de...
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| Main Authors: | , , , , , |
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| Format: | Article |
| Language: | English |
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Wiley
2019-01-01
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| Series: | Journal of Spectroscopy |
| Online Access: | http://dx.doi.org/10.1155/2019/4139762 |
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| _version_ | 1849473170587779072 |
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| author | Guolin Shi Bing Xu Xin Wang Zhong Xue Xinyuan Shi Yanjiang Qiao |
| author_facet | Guolin Shi Bing Xu Xin Wang Zhong Xue Xinyuan Shi Yanjiang Qiao |
| author_sort | Guolin Shi |
| collection | DOAJ |
| description | 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. |
| format | Article |
| id | doaj-art-d854a813bf8145cea2b92c5226be77ea |
| institution | Kabale University |
| issn | 2314-4920 2314-4939 |
| language | English |
| publishDate | 2019-01-01 |
| publisher | Wiley |
| record_format | Article |
| series | Journal of Spectroscopy |
| spelling | doaj-art-d854a813bf8145cea2b92c5226be77ea2025-08-20T03:24:15ZengWileyJournal of Spectroscopy2314-49202314-49392019-01-01201910.1155/2019/41397624139762Real-Time Release Testing of Herbal Extract Powder by Near-Infrared Spectroscopy considering the Uncertainty around Specification LimitsGuolin Shi0Bing Xu1Xin Wang2Zhong Xue3Xinyuan Shi4Yanjiang Qiao5Research Center of TCM Information Engineering, Beijing University of Chinese Medicine, Beijing 100029, ChinaResearch Center of TCM Information Engineering, Beijing University of Chinese Medicine, Beijing 100029, ChinaTianJin Children’s Hospital, TianJin 300204, ChinaSchool of Pharmacy, Hebei Medical University, Shijiazhuang 050017, ChinaResearch Center of TCM Information Engineering, Beijing University of Chinese Medicine, Beijing 100029, ChinaResearch Center of TCM Information Engineering, Beijing University of Chinese Medicine, Beijing 100029, ChinaThe 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.http://dx.doi.org/10.1155/2019/4139762 |
| spellingShingle | Guolin Shi Bing Xu Xin Wang Zhong Xue Xinyuan Shi Yanjiang Qiao Real-Time Release Testing of Herbal Extract Powder by Near-Infrared Spectroscopy considering the Uncertainty around Specification Limits Journal of Spectroscopy |
| title | Real-Time Release Testing of Herbal Extract Powder by Near-Infrared Spectroscopy considering the Uncertainty around Specification Limits |
| title_full | Real-Time Release Testing of Herbal Extract Powder by Near-Infrared Spectroscopy considering the Uncertainty around Specification Limits |
| title_fullStr | Real-Time Release Testing of Herbal Extract Powder by Near-Infrared Spectroscopy considering the Uncertainty around Specification Limits |
| title_full_unstemmed | Real-Time Release Testing of Herbal Extract Powder by Near-Infrared Spectroscopy considering the Uncertainty around Specification Limits |
| title_short | Real-Time Release Testing of Herbal Extract Powder by Near-Infrared Spectroscopy considering the Uncertainty around Specification Limits |
| title_sort | real time release testing of herbal extract powder by near infrared spectroscopy considering the uncertainty around specification limits |
| url | http://dx.doi.org/10.1155/2019/4139762 |
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