ISO 19609-2:2021
Traditional Chinese medicine — Quality and safety of raw materials and finished products made with raw materials — Part 2: Identity testing of constituents of herbal origin
This document specifies requirements for identity testing within a quality control framework for raw materials and finished products used in and as traditional Chinese medicine (TCM) and derivative forms. It is applicable to natural products used in TCM, including starting materials and finished products of herbal origin.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Minimum requirements for the testing of the identity of starting materials and finished products
5 Requirements for macroscopic, microscopic and organoleptic description tests
5.1 General
5.2 Macroscopic description test
5.2.1 Application
5.2.2 Macroscopic examination
5.2.3 Assessment
5.3 Microscopic description test
5.3.1 Application
5.3.2 Microscopic examination
5.3.3 Assessment
5.4 Organoleptic description test
5.4.1 Application
5.4.2 Organoleptic examination
5.4.3 Assessment
6 Chromatographic identification tests with HPLC and TLC
6.1 General
6.2 Sample preparation
6.2.1 General
6.2.2 Reagents
6.2.3 Apparatus
6.2.4 Sample preparation method for solids
6.2.5 Sample preparation method for semi-solid materials
6.2.6 Sample preparation method for liquids
6.2.7 Solid-phase extraction (SPE)
6.2.8 Test solution
6.3 Identification of constituents with HPLC and diode array detection
6.3.1 General
6.3.2 HPLC fingerprint testing method
6.4 Identification of typical constituents with TLC
6.4.1 Group selected identification tests with TLC
7 Chemical identification tests
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Minimum requirements for the testing of the identity of starting materials and finished products
5 Requirements for macroscopic, microscopic and organoleptic description tests
5.1 General
5.2 Macroscopic description test
5.2.1 Application
5.2.2 Macroscopic examination
5.2.3 Assessment
5.3 Microscopic description test
5.3.1 Application
5.3.2 Microscopic examination
5.3.3 Assessment
5.4 Organoleptic description test
5.4.1 Application
5.4.2 Organoleptic examination
5.4.3 Assessment
6 Chromatographic identification tests with HPLC and TLC
6.1 General
6.2 Sample preparation
6.2.1 General
6.2.2 Reagents
6.2.3 Apparatus
6.2.4 Sample preparation method for solids
6.2.5 Sample preparation method for semi-solid materials
6.2.6 Sample preparation method for liquids
6.2.7 Solid-phase extraction (SPE)
6.2.8 Test solution
6.3 Identification of constituents with HPLC and diode array detection
6.3.1 General
6.3.2 HPLC fingerprint testing method
6.4 Identification of typical constituents with TLC
6.4.1 Group selected identification tests with TLC
7 Chemical identification tests
Bibliography