ISO 21314:2026

• Abstract:

  This document specifies the requirements and test methods for Salvia miltiorrhiza root and rhizome, which are derived from the Salvia miltiorrhiza Bge. plant. It is applicable to Salvia miltiorrhiza root and rhizome that are sold and used as a natural medicine in international trade, including unprocessed and traditionally processed materials.

• Status: Published
• Publication Date: 02-Aug-2026
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 1 - Quality and safety of raw materials and traditional processing
• Current Stage: 6060 - International Standard published
• Start Date: 03-Aug-2026
• Due Date: 05-Aug-2026
• Completion Date: 03-Aug-2026

• Revises: ISO 21314:2019 - Traditional Chinese medicine — Salvia miltiorrhiza root and rhizome
• Effective Date: 08-Feb-2025

ISO 21314:2026 is an ISO International Standard for Salvia miltiorrhiza root and rhizome used in traditional Chinese medicine. It specifies the requirements, sampling, test methods, packaging, storage, transport, marking and labelling for materials sold and used as a natural medicine in international trade, including unprocessed and traditionally processed forms.

What does ISO 21314:2026 specify?

ISO 21314:2026 sets technical requirements for identifying and testing Salvia miltiorrhiza root and rhizome derived from the Salvia miltiorrhiza Bge. plant. It is organized into clauses for scope, references, terms, descriptions, quality requirements, sampling, test methods, reporting, packaging, and marking.

Annex	What it covers
Annex A	TLC identification
Annex B	Determination of extractives
Annex C	Determination of tanshinones
Annex D	Determination of salvianolic acid B
Annex E	National and regional requirements

The scope covers materials used in international trade as natural medicine, and it explicitly includes both unprocessed and traditionally processed materials. That matters in practice because buyers, processors, and laboratories can use the same standard for incoming raw material and for trade specifications after traditional processing.

What are the key requirements of ISO 21314:2026?

ISO 21314:2026 combines visual, chromatographic, physicochemical, and packaging requirements so a lot can be checked before release or trade. The most important controls are in Clause 5, with supporting sampling and test methods in Clauses 6 and 7.

General appearance and cleanliness

Clause 5.1 requires the material to be clean and free from foreign matter, and it forbids living insects, mouldy root and rhizome, and visible external contaminants. In practice, this is the first acceptance check for sorting, inspection, and incoming goods control.

Morphological identification

Clause 5.2.1 describes the expected form of the rhizomes and roots, including their shape, colour, texture, fracture and size range. This helps inspectors confirm that the material matches the correct herbal drug before more detailed testing.

TLC identification

Clause 5.2.2 requires thin-layer chromatogram (TLC) identification to show spots or bands specific to Salvia miltiorrhiza root and rhizome. This gives a identity check that is especially useful when the material is ground, mixed, or traded in bulk.

Moisture, ash, and extractives

Clause 5.2.3 limits moisture, Clause 5.2.4 limits total ash, and Clause 5.2.5 limits acid-insoluble ash. Clause 5.2.6 covers water-soluble extractives and ethanol-soluble extractives, with the ethanol-soluble extractives subject to a minimum limit. In practice, these tests help detect poor drying, mineral contamination, and variation in soluble constituents that can affect quality and shelf life.

Marker compounds

Clause 5.2.7 requires determination of marker compounds, including tanshinones and salvianolic acid B, and sets minimum levels for them. This matters because these compounds are used as quality indicators for the herbal drug and are tied to the chemical identity of the material.

Heavy metals and pesticide residues

Clause 5.2.8 requires determination of heavy metals including arsenic, mercury, lead and cadmium. Clause 5.2.9 requires determination of pesticide residues such as Benzex, DDT and quintozene. These controls support safety screening for trade and use.

Sampling, reporting, packaging and labelling

Clause 6 requires sampling in accordance with ISO 23723. Clause 7 gives the test methods, including macroscopic identification, TLC, moisture, ash, extractives, tanshinones, salvianolic acid B, heavy metals and pesticide residues. Clause 8 sets out what a test report shall record, while Clauses 9 and 10 require packaging that protects the product and marking that identifies the product name, scientific name, quality features, origin, production details, lot number, expiry date, and storage and transport method.

What terms does ISO 21314:2026 define?

ISO 21314:2026 defines the key technical terms used to judge the material consistently.

• Salvia miltiorrhiza root and rhizome - the underground part of Salvia miltiorrhiza.
• Total ash - the residue left after incineration at the specified temperature range.
• Acid-insoluble ash - the part of the total ash that remains after treatment with hydrochloric acid.
• Tanshinones - the marker compounds tanshinone IIA, cryptotanshinone and tanshinone I.
• Water-soluble extractives - the fraction extracted by water and measured as an indicator of soluble constituents.
• Ethanol-soluble extractives - the fraction extracted by ethanol and measured as another quality indicator.

These terms matter because laboratories, traders, and regulators need the same meaning when they compare test results or write specifications.

Who uses ISO 21314:2026?

ISO 21314:2026 is used by people who buy, sell, inspect, sample, test, package, and label Salvia miltiorrhiza root and rhizome. That includes herbal medicine manufacturers, traders in international supply chains, laboratory analysts, quality managers, and buyers who need a defined acceptance basis.

It is also relevant to organizations working with traditional Chinese medicine, since the introduction says the herb is used in products, supplements, and cosmetics, and that quality differences between cultivators can affect safety and efficacy. In practice, the standard helps with incoming inspection, release testing, and writing product specifications.

What changed in ISO 21314:2026 from the previous edition?

ISO 21314:2026 is the second edition and it cancels and replaces ISO 21314:2019. The document states that it has been technically revised.

The listed changes are:

• Clause 5.2.7 and Clause 5.2.8 were combined into one subclause titled Content of compound markers.
• Annex E was updated with the editions of the Chinese Pharmacopoeia and the Korea Pharmacopoeia.
• Clause 2 and the Bibliography were updated.

Which standards are used with ISO 21314:2026?

ISO 21314:2026 cites three normative references.

• ISO 23723 - provides the general requirements for herbal raw material and materia medica, and is used for sampling and several test methods in this document.
• ISO 18664 - provides the heavy metals determination method used for Clause 7.9.
• ISO 22258 - provides the pesticide residue determination method used for Clause 7.10.

These references matter because ISO 21314:2026 relies on them for the testing approach rather than restating every method in full.

What does the ISO 21314:2026 document contain?

ISO 21314:2026 contains the full set of quality and test provisions needed to specify the herbal drug for trade and laboratory control. It includes clause-level requirements for morphology, TLC identity, moisture, ash, extractives, compound markers, heavy metals, pesticide residues, sampling, reporting, packaging, storage, and labelling.

The annexes provide the practical test work: Annex A gives TLC preparation and identification, Annex B gives extraction procedures and calculation formulas, Annex C gives the HPLC method for tanshinones, and Annex D gives the HPLC method for salvianolic acid B. Annex E compares national and regional requirements, which is useful when aligning international specifications with local pharmacopoeial limits.

International
Standard
ISO 21314
Second edition
Traditional Chinese medicine —
2026-08
Salvia miltiorrhiza root and rhizome
Médecine traditionnelle chinoise — Racine et rhizome de Salvia
miltiorrhiza
Reference number
© ISO 2026
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
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or ISO’s member body in the country of the requester.
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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 Requirements and recommendations . 3
5.1 General characteristics .3
5.2 Salvia miltiorrhiza root and rhizome.3
5.2.1 Morphological features of root and rhizome . .3
5.2.2 Thin-layer chromatogram (TLC) identification .3
5.2.3 Moisture .3
5.2.4 Total ash .3
5.2.5 Acid-insoluble ash limit .3
5.2.6 Extractives .3
5.2.7 Content of marker compounds . .3
5.2.8 Heavy metals .4
5.2.9 Pesticide residues .4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification .4
7.2 Thin-layer chromatogram(TLC) identification .4
7.3 Determination of moisture content .4
7.4 Determination of total ash .4
7.5 Determination of acid-insoluble ash .4
7.6 Determination of extractives .4
7.7 Determination of tanshinones .4
7.8 Determination of salvianolic acid B .4
7.9 Determination of heavy metals .4
7.10 Determination of pesticide residues .5
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) Thin-layer chromatogram(TLC) identification . 6
Annex B (informative) Determination of extractives . 8
Annex C (informative) Determination of tanshinones . 9
Annex D (informative) Determination of salvianolic acid B .12
Annex E (informative) National and regional requirements for Salvia miltiorrhiza root and
rhizome . 14
Bibliography .15

iii
Foreword
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in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
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related to conformity assessment, as well as information about ISO's adherence to the World Trade
Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, Subcommittee SC 1,
Traditional Chinese medicine.
This second edition cancels and replaces the first edition (ISO 21314:2019), which has been technically
revised.
The main changes are as follows:
— 5.2.7 and 5.2.8: combination of 5.2.7 and 5.2.8 in to a single subclause with the title “Content of compound
markers”;
— Annex E : update of the edition of the Chinese Pharmacopoeia and the Korea Pharmacopoeia;
— update of Clause 2 and Bibliography.
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
Salvia miltiorrhiza Bge. is a perennial herbal plant in the Lamiaceae family. The root and rhizome of this
plant have been used as traditional Chinese medicines for more than 2 500 years. Used as raw material,
Salvia miltiorrhiza root and rhizome (Danshen) have been developed into various kinds of herbal medicine
products and used in at least 19 countries or regions for their therapeutic value and market potential in the
treatment of cardiovascular diseases, neurasthenic insomnia, liver fibrosis and cancer. It has also been used
as an ingredient in health supplements and cosmetics.
Salvia miltiorrhiza Bge. is mainly grown and cultivated in China, but is also cultivated in the USA, Germany,
Great Britain and Australia. However, the quality of Salvia miltiorrhiza root and rhizome (Danshen) provided
by different cultivators is quite different, which can affect the safety and efficacy of this herb.
[1] [2] [3] [4] [5] [6]
Salvia miltiorrhiza root and rhizome (Danshen) has been recorded by , , , , and . However,
these national or regional standards are not harmonized and can be unfavourable for the international
trade of Salvia miltiorrhiza root and rhizome (Danshen) . One of the significant differences between them is
that different chemical markers, or the same chemical markers with different limitations, are used. These
chemical markers provide a vital index for judging the quality of Salvia miltiorrhiza root and rhizome.
Therefore, the establishment of an international standard for Salvia miltiorrhiza root and rhizome (Danshen)
is important for the international trade of this herb and also for ensuring the consistent quality and safety of
this herb in clinical use.
As national implementation can differ, national standards bodies are invited to modify the values given in
5.2.3, 5.2.4, 5.2.5, 5.2.6.1, 5.2.6.2 and 5.2.7 in their national standards. Examples of national and regional
values are given in Annex E.
v
International Standard ISO 21314:2026(en)
Traditional Chinese medicine — Salvia miltiorrhiza root and
rhizome
1 Scope
This document specifies the requirements and test methods for Salvia miltiorrhiza root and rhizome, which
are derived from the Salvia miltiorrhiza Bge. plant.
It is applicable to Salvia miltiorrhiza root and rhizome that are sold and used as a natural medicine in
international trade, including unprocessed and traditionally processed materials.
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 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by gas
chromatography
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
Salvia miltiorrhiza root and rhizome
underground part of Salvia miltiorrhiza
3.2
total ash
residue obtained after incineration at (525 ± 25) °C
3.3
acid-insoluble ash
part of the total ash (3.2) remaining after treatment with hydrochloric acid
3.4
tanshinones
tanshinone IIA (C H O ), cryptotanshinone (C H O ) and tanshinone I (C H O )
19 18 3 19 20 3 18 12 3
4 Descriptions
Salvia miltiorrhiza root and rhizome are the dried root and rhizome of Salvia miltiorrhiza Bunge. in the
Lamiaceae (Labiatae) family as shown in Figure 1.
a) Aerial part of Salvia miltiorrhiza plant b) Dried root and rhizome
Key
1 raceme
2 leaf
3 stem
4 flower (showing stamen)
5 calyx
6 rhizome
7 fibrous root
8 root
NOTE Schematic representation, not to scale.
Figure 1 — Structure of Salvia miltiorrhiza

5 Requirements and recommendations
5.1 General characteristics
The following requirements shall be met before separating the bulk sample into test samples:
a) Salvia miltiorrhiza root and rhizome shall be clean and free from foreign matter.
b) The presence of living insects, mouldy root and rhizome and external contaminants which are visible to
the naked eye shall not be permitted.
5.2 Salvia miltiorrhiza root and rhizome
5.2.1 Morphological features of root and rhizome
a) The rhizomes are short and stout, sometimes with a stem at the apex.
b) The roots are long, cylindrical and slightly curved. Some are branched and with rootlets.
c) The roots are 10 cm to 20 cm long, 0,3 cm to 1,5 cm in diameter.
d) The outer surface is brownish-red or dark brownish-red with rough and wrinkled longitudinal texture.
The bark of old roots is loose, mostly purp
...