ISO 5471:2024

International
Standard
ISO 5471
First edition
Traditional Chinese medicine —
2024-12
Carthamus tinctorius flower
Médecine traditionnelle chinoise — Fleur de carthame des
teinturiers (Carthamus tinctorius)
Reference number
© ISO 2024
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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 Quality and safety requirements and recommendations . 2
5.1 General characteristics .2
5.2 Morphological features .2
5.3 Thin-layer chromatography feature . . .3
5.4 Moisture .3
5.5 Total ash .3
5.6 Acid-insoluble ash .3
5.7 Absorbance .3
5.8 Water-soluble extract .3
5.9 Marker compound(s) .3
5.10 Heavy metals .3
5.11 Pesticide residues .3
5.12 Sulfur dioxide . .3
5.13 Aflatoxins .3
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification .4
7.2 Thin-layer chromatography identification .4
7.3 Determination of moisture .4
7.4 Determination of total ash .4
7.5 Determination of acid-insoluble ash .4
7.6 Determination of absorbance of red pigment .4
7.7 Determination of water-soluble extract .4
7.8 Determination of marker compound(s).4
7.9 Determination of heavy metals .4
7.10 Determination of pesticide residues .4
7.11 Determination of sulfur dioxide content .4
7.12 Determination of aflatoxins . .4
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) Thin-layer chromatography (TLC) identification . 6
Annex B (informative) Determination of absorbance of red pigment . 7
Annex C (informative) Determination of hydroxysafflor yellow A content . 8
Annex D (informative) Determination of kaempferol content .11
Annex E (informative) Reference values of national and regional limits for Carthamus tinctorius
flower . 14
Bibliography .16

iii
Foreword
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iv
Introduction
Carthamus tinctorius flower, the dried flower of Carthamus tinctorius Linné (Compositae), is a medicinal herb
used to treat menstrual problems, cardiovascular disease, pain, and swelling associated with trauma in
Asian countries and the Mediterranean region for thousands of years.
There are at least 60 countries worldwide using or producing Carthamus tinctorius flower and its products.
Major users include India, China, the United States, Iran, Canada, Australia, Republic of Korea, etc. Due
to its great demand in the global market, trade in Carthamus tinctorius flower has been complicated by
adulteration and substitution issues. Dishonest vendors add sand, saline and syrup to increase the weight
for sale. Stains such as golden orange II, lemon yellow, and carmine, are sometimes used to make its colour
brighter, which can cause health risks. Factors including contamination, packaging and storage conditions
also affect the quality of Carthamus tinctorius flower.
The establishment of an international standard for Carthamus tinctorius flower is therefore necessary to
support its quality consistency, clinical effectiveness and safety in international trade.
As national implementation can differ, national standards bodies are invited to modify the values given in
5.4, 5.5, 5.6, 5.7 and 5.8 in their national standards. Examples of national and regional values are given in
Annex E.
v
International Standard ISO 5471:2024(en)
Traditional Chinese medicine — Carthamus tinctorius flower
1 Scope
This document specifies the minimum requirements and test methods for Carthamus tinctorius flower that
is derived from Carthamus tinctorius Linné.
It is applicable to Carthamus tinctorius flower that is sold and used as Chinese materia medica.
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 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 22283, Traditional Chinese medicine — Determination of aflatoxins in natural products by LC-FLD
ISO 22590, Traditional Chinese medicine — Determination of sulfur dioxide in natural products by titration
ISO 23723, 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:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
Carthamus tinctorius flower
dried tubulous flower (3.2) of Carthamus tinctorius Linné (Compositae)
3.2
tubulous flower
flower with a long, thin, straight-sided tube formed of united petals, often separating at the mouth into a
flared shape
3.3
tubular corolla
regular and gamopetalous corolla with the petals fused to form a tube

4 Descriptions
Carthamus tinctorius flower is the dried tubulous flower of Carthamus tinctorius Linné (Compositae). The
flower is collected in summer when it turns from yellow to red, then dried in a shaded area or under the sun,
as shown in Figure 1.
A B C
Key
A plant with capitulum
B single tubulous flower
C stigma and stamen
1 tubulous flower
2 lobe
3 phyllary
4 tubular corolla
5 stigma
6 stamens
Figure 1 — Structure of Carthamus tinctorius flower
5 Quality and safety requirements and recommendations
5.1 General characteristics
The following requirements shall be met before sampling:
a) Carthamus tinctorius flower shall be clean and fr
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