Real-time determination of the start and end points of elution in column chromatography during the production process of traditional Chinese medicine (T/CIS 11005-2023) using near-infrared spectroscopy

Scope

Scope: This document specifies the method for real-time determination of the start and end points of elution in column chromatography during the production of traditional Chinese medicine (TCM), as well as the instrument parameters and installation requirements. It also describes the corresponding technical principles, spectrum data acquisition, and data processing and presentation. This document is applicable to the real-time determination of the start and end points of elution in column chromatography during the production of TCM. Main technical contents: Foreword II. Scope III. Normative reference documents IV. Terms and definitions V. Principles VI. Test instruments and standard substances VI.1. Test instruments VI.2. Standard substances VII. Determination of the start and end points of column chromatography VII.1. Spectrum data acquisition VII.2. Spectrum preprocessing VII.3. Establishment of the MBSD model and determination of the start and end points VIII. Model validation VIII.1. Sufficiency VIII.2. Specificity IX. Test report X. Appendix A (informative) - Schematic diagram of the near-infrared spectrometer installation XI. Appendix B (informative) - Two examples of online determination of the start and end points of column chromatography during the production of TCM XII. References XIII.

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