ISO 23723:2021

INTERNATIONAL ISO
STANDARD 23723
First edition
2021-08
Traditional Chinese medicine —
General requirements for herbal raw
material and materia medica
Médecine traditionnelle chinoise — Exigences générales relatives aux
matières premières issues des plantes et à la matière médicale
Reference number
©
ISO 2021
© ISO 2021
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Contents Page
Foreword .v
Introduction .vi
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General principle . 2
5 Requirements for all Chinese materia medica . 3
5.1 General . 3
5.2 Identification . 3
5.3 Quality requirements . 3
5.3.1 Moisture and loss on drying . 3
5.3.2 Foreign matter . 3
5.4 Safety requirements . 3
5.4.1 Heavy metals and arsenic . 3
5.4.2 Pesticide residues . 3
6 Requirements for specific Chinese materia medica . 3
6.1 Quality requirements . 3
6.1.1 Total ash and acid-insoluble ash . 3
6.1.2 Assay . . . 3
6.1.3 Extractives . 4
6.1.4 Essential oil . 4
6.1.5 Rancidity . 4
6.1.6 Degree of colouration . 4
6.2 Safety requirements . 4
6.2.1 Sulfur dioxide residues . 4
6.2.2 Aflatoxins . 4
6.2.3 Aristolochic acids . 4
6.2.4 Aconitum alkaloids . 4
6.2.5 Microbial contamination . 4
7 Methods . 4
7.1 Identification . 4
7.1.1 Macroscopic identification . 4
7.1.2 Microscopic identification . 5
7.1.3 TLC identification and HPLC identification . 5
7.2 Quality tests . 5
7.2.1 Moisture and loss on drying . 5
7.2.2 Foreign matter . 5
7.2.3 Total ash and acid-insoluble ash . 5
7.2.4 Assay . . . 5
7.2.5 Extractives . 5
7.2.6 Essential oil . 5
7.2.7 Rancidity . 6
7.2.8 Degree of colouration . 6
7.3 Safety test . 6
7.3.1 Heavy metal and arsenic . 6
7.3.2 Pesticide residues . 7
7.3.3 Sulfur dioxide residues . 7
7.3.4 Aflatoxins . 7
7.3.5 Aristolochic acids . 7
7.3.6 Aconitum alkaloids . 7
7.3.7 Microbial contamination . 7
8 Sampling . 7
9 Test report . 8
10 Packaging . 8
11 Labelling . 8
12 Storage and transportation . 8
Annex A (informative) Test information of single herbs in national and regional pharmacopoeias 9
Bibliography .100
iv © ISO 2021 – All rights reserved

Foreword
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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
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Introduction
Chinese herbal medicine, as an important component of traditional Chinese medicine, is widely used in
many countr
...