Open AccessReal-Time Release Testing of Herbal Extract Powder by Near-Infrared Spectroscopy considering the Uncertainty around Specification Limits
Author(s) -
Guolin Shi,
Bing Xu,
Xin Wang,
Zi Xue,
Xiaowen Shi,
Yanjiang Qiao
Publication year - 2019
Publication title -
journal of spectroscopy
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.323
H-Index - 21
eISSN - 2314-4920
pISSN - 2314-4939
DOI - 10.1155/2019/4139762
Subject(s) - computer science , reliability (semiconductor) , calibration , near infrared spectroscopy , reliability engineering , quality (philosophy) , process analytical technology , product (mathematics) , process engineering , mathematics , engineering , work in process , statistics , power (physics) , physics , philosophy , geometry , epistemology , quantum mechanics , operations management
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 tanshinoneII A 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.