ISO 23959:2021

INTERNATIONAL ISO
STANDARD 23959
First edition
2021-08
Traditional Chinese medicine —
Glehnia littoralis root
Médecine traditionnelle chinoise — racine de Glehnia littoralis
Reference number
©
ISO 2021
© ISO 2021
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ii © ISO 2021 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Requirements . 3
5.1 General characteristics . 3
5.2 Macroscopic characteristics . 4
5.3 Microscopic characteristics . 4
5.3.1 Transverse section characteristics . 4
5.3.2 Powder characteristics . 4
5.4 Moisture . 4
5.5 Total ash . 4
5.6 Acid-insoluble ash . 5
5.7 Thin-layer chromatogram identification . 5
5.8 Marker compounds . 5
5.9 Heavy metals . 5
5.10 Pesticide residues . 5
5.11 Sulfur dioxide residue . 5
6 Sampling . 5
7 Test methods . 6
7.1 Macroscopic identification . 6
7.2 Microscopic identification . 6
7.2.1 Transverse section examination . 6
7.2.2 Powder examination . 6
7.3 Determination of moisture . 6
7.4 Determination of total ash . 6
7.5 Determination of acid-insoluble ash . 6
7.6 TLC identification . 6
7.7 Determination of marker compounds . 6
7.8 Determination of heavy metals . 6
7.9 Determination of pesticide residues . 6
7.10 Determination of sulfur dioxide residue . 7
8 Test report . 7
9 Packaging, storage and transportation . 7
10 Marking and labelling . 7
Annex A (informative) Microscopic identification . 8
Annex B (informative) TLC identification . 9
Annex C (informative) Determination of falcarinol .11
Annex D (informative) Referenced values of national and regional limits of moisture, total
ash, acid-insoluble ash, falcarinol and heavy metals in Glehnia littoralis root .13
Bibliography .14
Foreword
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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
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iv © ISO 2021 – All rights reserved

Introduction
Glehnia littoralis root is the dried or dried peeled root of Glehnia littoralis Fr. Schmidt ex Miq. (Apiaceae),
which is recorded in the Chinese, Japanese and Korean pharmacopoeias, Hong Kong Chinese Materia
Medica Standards and Taiwan herbal pharmacopoeia. Glehnia littoralis root is internationally recognized
as a medicinal material and there is great demand for it in the international market. However, there
are many problems seriously affecting the international trade of Glehnia littoralis root, including the
following:
1) Quality requirements for Glehnia littoralis root are different among different countries and regions.
2) Glehnia littoralis root is often substituted with fake and inferior Glehnia littoralis root.
3) Different collecting times, processing methods, packaging, transportation and storage conditions
often result in different qualities of Glehnia littoralis root.
Therefore, the establishment of an International Standard for Glehnia littoralis root is necessary
to guarantee the quality, safety and consistency of this valuable herbal medicine. This document
includes sections on morphology evaluation (general, macroscopic and microscopic characteristics),
physicochemical indexes (moisture, total ash, acid-insoluble ash, maker compounds, pesticide residues
and sulfur dioxide residue) and heavy metal (lead, arsenic, cadmium and mercury) content.
As national implementation may differ, national standards bodies are invited to modify the values
given in 5.4, 5.5, and 5.6 in their national standards. Examples of national and regional values are given
in Annex D.
INTERNATIONAL STANDARD ISO 23959:2021(E)
Traditional Chinese medicine — Glehnia littoralis root
1 Scope
This document specifies the quality and safety requirements of Glehnia littoralis root, which is derived
from the plant Glehnia littoralis Fr Schmidt ex Miq.
This document applies to Glehnia littoralis root that is sold and used as natural medicine in international
trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from
this plant.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements of this document. For dated references, only the edition cited applies. For
undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 1575, Tea — Determination of total ash
ISO 1577, Tea — Determination of acid-insoluble ash
ISO 1666, Starch — Determination of moisture content — Oven-drying method
ISO 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical
use
ISO 22217, Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces
ISO 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by gas
chromatography
ISO 22590, Traditional Chinese med
...