ISO 5471:2024

Traditional Chinese medicine - Carthamus tinctorius flower

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.

Médecine traditionnelle chinoise — Fleur de carthame des teinturiers (Carthamus tinctorius)

General Information

• Status: Published
• Publication Date: 16-Dec-2024
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249 - Traditional Chinese medicine
• Current Stage: 6060 - International Standard published
• Start Date: 17-Dec-2024
• Due Date: 15-Mar-2026
• Completion Date: 17-Dec-2024

Overview

ISO 5471:2024 - Traditional Chinese medicine - Carthamus tinctorius flower is the first edition (2024) international standard that defines minimum quality, safety and test-method requirements for dried Carthamus tinctorius Linné flowers (safflower) when sold and used as Chinese materia medica. The standard addresses identification, contamination risks and analytical tests to support consistent quality, clinical effectiveness and safe international trade of Carthamus tinctorius flower.

Key technical topics and requirements

• Scope and applicability
  • Applies to the dried tubulous flower of Carthamus tinctorius Linné used in Traditional Chinese Medicine (TCM) and global trade.
• Identity and macroscopic description
  • Morphology: tubulous flower length, tubular corolla colour (orange‑red to red), 5‑lobed apex, stamens and stigma features; odour slightly fragrant, taste slightly bitter.
• Analytical limits and quality criteria
  • Moisture: mass fraction ≤ 13.0%
  • Total ash: mass fraction ≤ 18.0%
  • Acid‑insoluble ash: mass fraction ≤ 5.0%
  • Absorbance (red pigment at 518 nm): ≥ 0.20
  • Water‑soluble extract: mass fraction ≥ 30.0%
  • Marker compounds: determination of flavonoids, e.g. hydroxysafflor yellow A and kaempferol
  • Contaminants: determination of heavy metals (As, Hg, Pb, Cd), pesticide residues, sulfur dioxide and aflatoxins
• Identification and test methods
  • Macroscopic inspection and thin‑layer chromatography (TLC) for identity (Annex A)
  • Specific test methods and procedures for moisture, ash, pigment absorbance (Annex B), marker quantification (Annex C/D), and contamination testing
• Sampling, reporting and handling
  • Sampling per ISO 23723; requirements for test reporting, packaging, storage, transportation, marking and labelling are specified.

Practical applications - who uses ISO 5471:2024

• Quality control laboratories testing herbal raw materials for compliance with TCM standards
• Manufacturers and suppliers of TCM herbs and botanical ingredients to ensure product consistency
• Regulators and customs authorities assessing imported/exported Carthamus tinctorius flower for safety and labelling compliance
• Herbal product formulators and distributors seeking verified raw‑material specifications
• Research institutions conducting pharmacognosy or phytochemical studies on safflower constituents (hydroxysafflor yellow A, kaempferol)
• Buyers and traders who need to mitigate adulteration risks (added pigments, fillers, contaminants)

Related standards and supporting documents

Normative references cited in ISO 5471:2024 include:

• ISO 23723 (sampling and general requirements for herbal raw material and materia medica)
• ISO 18664 (heavy metals)
• ISO 22258 (pesticide residues)
• ISO 22283 (aflatoxins)
• ISO 22590 (sulfur dioxide)
• ISO 21371 (labelling) and ISO 22217 (storage)

ISO 5471:2024 helps harmonize herbal medicine testing, safflower quality control, and international trade practices for Carthamus tinctorius flower.

Standards Content (Sample)

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
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
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Published in Switzerland
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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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

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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