ISO 21590:2026

International
Standard
ISO 21590
First edition
Traditional Chinese medicine —
2026-02
Crocus sativus stigma
Médecine traditionnelle chinoise — Stigmate de Crocus sativus
Reference number
© ISO 2026
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Requirements and recommendations . 2
5.1 General characteristics .2
5.2 Morphological features .3
5.3 Microscopic identification .3
5.4 Thin-layer chromatogram (TLC) identification .4
5.5 Moisture .4
5.6 Total ash .4
5.7 Heavy metals .4
5.8 Pesticide residues .4
5.9 Artificial colorants .4
5.10 Marker compound(s) .4
6 Sampling . 4
7 Test methods . 4
7.1 Morphological features .4
7.2 Microscopic identification .4
7.3 Thin-layer chromatogram identification .4
7.4 Determination of moisture .4
7.5 Determination of total ash .4
7.6 Determination of heavy metals .5
7.7 Determination of pesticide residues .5
7.8 Determination of artificial colouring .5
7.9 Determination of marker compound(s).5
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) Thin-layer chromatography (TLC) identification . 7
Annex B (informative) Determination of marker compound(s) by HPLC-UV . 8
Annex C (informative) Reference information of national and regional requirements .10
Bibliography .11

iii
Foreword
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This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, Subcommittee SC 1,
Traditional Chinese medicine.
Any feedback or questions on this document should be directed to the user’s national standards body. A
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iv
Introduction
Crocus sativus stigma (Xihonghua) is originally native to Europe and was introduced in China via the Silk
Road for application in traditional Chinese medicine. In China, Crocus sativus stigma was first recorded in
[1]
Bencao Pinhui Jingyao  in 1505. The primary producers of Crocus sativus stigma include countries such
as Iran, India, Spain, Afghanistan, Greece and Italy, with emerging countries like China gaining prominence.
Crocus sativus stigma is utilized medicinally in over 100 countries, thereby facilitating its global trade and
its significant role in pharmaceutical applications. However, no international standard exists to evaluate the
quality of Crocus sativus stigma as a raw material of traditional Chinese medicine.
The main chemical constituents of Crocus sativus stigma include carotene and volatile oil. Modern
pharmacological studies have shown that crocin-I and crocin-II in Crocus sativus stigma have definite
benefits for neurodegenerative diseases, mental disorders, epilepsy, seizures and insomnia, as well as
several cardiovascular system conditions including hypertension, hyperlipidemia and atherosclerosis.
China, Japan, South Korea, India and Europe have established standards for Crocus sativus stigma in their
respective pharmacopoeias. But each pharmacopoeia’s requirements are different. The Crocus sativus stigma
standard has not been unified at the international level, and many countries have different regulation levels.
As national implementation can differ, national standards bodies are invited to modify the values given in
5.5 and 5.6 in their national standards. An example of national values is given in Annex C.

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International Standard ISO 21590:2026(en)
Traditional Chinese medicine — Crocus sativus stigma
1 Scope
This document specifies the minimum quality and safety requirements for Crocus sativus stigma.
It applies to Crocus sativus stigma that is sold and used as natural medicines in international trade, including
in Chinese materia medica and decoction pieces.
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 3632-2, Spices — Saffron (Crocus sativus L.) — Part 2: Test methods
ISO 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
ISO/TS 21310, Traditional Chinese medicine — Microscopic examination of medicinal herbs
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 23723:2021, Traditional Chinese medicine — General requirements for herbal raw material and materia
medica
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminology databases for use in standardization at the following addresses:
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