ISO 21756:2026

• Abstract:

  This document specifies the technical requirements for the quality and safety of industrial manufacturing procedures and quality of Salvia miltiorrhiza root and rhizome aqueous extract granules. It is applicable to Salvia miltiorrhiza root and rhizome aqueous extract granules that are sold and used in international trade.

• Status: Published
• Publication Date: 21-Jul-2026
• 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: 22-Jul-2026
• Due Date: 09-Nov-2026
• Completion Date: 22-Jul-2026

Overview

ISO 21756:2026 specifies the technical requirements for the quality and safety of industrial manufacturing procedures and the quality of Salvia miltiorrhiza root and rhizome aqueous extract granules. Known more widely as Danshen, Salvia miltiorrhiza is a traditional Chinese medicinal herb with over 2,500 years of therapeutic use. This ISO international standard supports manufacturers, regulators, and stakeholders in ensuring the consistent production and trade of Salvia miltiorrhiza aqueous extract granules for medicinal applications worldwide.

The document outlines comprehensive requirements for raw materials, extraction, granulation, identification, testing, packaging, storage, and safety assurance. It is intended for products sold and used in international trade, providing a basis for effective quality control and safety compliance in the global market for traditional Chinese medicine (TCM).

Key Topics

• Raw Material Quality: The standard requires Salvia miltiorrhiza roots and rhizomes to meet specific sourcing and pre-treatment criteria, referencing ISO 21314.
• Manufacturing Processes: Details quality specifications for extraction, concentration, drying, and granulation.
• Product Characterization: Describes granule appearance, taste, and odor profile, ensuring standardized sensory properties.
• Qualitative Identification: Outlines requirements for Thin-Layer Chromatographic (TLC) and High-Performance Liquid Chromatography (HPLC) analysis to verify key marker compounds (notably salvianolic acid B).
• Quality Parameters: Establishes acceptable ranges for marker compounds, ethanol-soluble extractives, moisture content, and particle size distribution (using ISO 23419).
• Safety Assurance:
  • Heavy metals and harmful elements (ISO 18664)
  • Pesticide residues (ISO 22258)
  • Microorganism presence (ISO 22467), with specific thresholds for aerobic bacteria, molds, and yeasts, and absence of Escherichia coli.
• Uniformity and Dissolution: Mandates test methods for dose uniformity and dissolution characteristics, referencing ISO 19609-1.
• Packaging and Labelling: Provides packaging and labelling guidance consistent with ISO 18668-4, ISO 21371, and ISO 23419.
• Storage and Transport: Recommends best-practice conditions to prevent contamination and degradation during storage and shipment (referencing ISO 22217).

Applications

• Manufacturing Compliance: Assists herbal medicine producers in controlling quality and consistency from raw material selection to finished product packaging, ensuring compliance with international standards.
• Regulatory Approval: Supports regulatory agencies in assessing the safety, efficacy, and quality of TCM granule products intended for international markets.
• Trade Facilitation: Harmonizes technical requirements to ease cross-border trade, fostering wider acceptance and trust in traditional Chinese medicine granules.
• Quality Assurance and Control: Sets standardized procedures for laboratory testing and product validation, reducing variation between batches and among manufacturers.
• Healthcare Integration: Promotes the safe integration of traditional Chinese medicinal products, like Salvia miltiorrhiza granules, in both clinical and retail settings worldwide.

Related Standards

For comprehensive quality and safety management of Salvia miltiorrhiza root and rhizome aqueous extract granules, the following related ISO standards are directly referenced or complement ISO 21756:2026:

• ISO 21314: Salvia miltiorrhiza root and rhizome - raw material standards
• ISO 23419: General requirements for manufacturing procedures and quality assurance of granules
• ISO 19609-1: General requirements for quality and safety of raw materials and finished products - Part 1
• ISO 18664: Determination of heavy metals in herbal medicines
• ISO 22258: Determination of pesticide residues in natural products by gas chromatography
• ISO 22467: Determination of microorganisms in natural products
• ISO 21371: Labelling requirements for traditional Chinese medicine products
• ISO 18668-4: Coding system for granule forms of individual medicinals for prescriptions
• ISO 22217: Storage requirements for raw materials and decoction pieces

Conclusion

Adhering to ISO 21756:2026 ensures that producers and distributors of Salvia miltiorrhiza root and rhizome aqueous extract granules deliver safe, high-quality, and standardized products. Leveraging this international standard enhances consumer protection, supports regulatory compliance, and promotes the global integration of traditional Chinese medicine products.

Keywords: ISO 21756:2026, Salvia miltiorrhiza, traditional Chinese medicine, aqueous extract granules, quality requirements, safety assurance, manufacturing procedures, international trade, herbal granules standard.

International
Standard
ISO 21756
First edition
Traditional Chinese medicine —
2026-07
Salvia miltiorrhiza root and rhizome
aqueous extract granules
Médecine traditionnelle chinoise — Granulés d'extrait aqueux de
racine et de 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
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or ISO’s member body in the country of the requester.
ISO copyright office
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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 Requirements of manufacturing procedures . 2
5 Description . . 2
6 Qualitative identification . 2
6.1 Thin-Layer chromatographic (TLC) identification .2
6.2 Characteristic chromatogram .2
6.3 Marker compound .2
6.4 Determination of ethanol-soluble extractives .2
6.5 Determination of water or moisture content .2
6.6 Particle size and particle size distribution .2
6.7 Dissolution or disintegration .3
6.8 Uniformity of dosage unit .3
7 Requirements of safety assurance . 3
7.1 Heavy metals and harmful elements .3
7.2 Pesticide residues .3
7.3 Microorganism .3
8 Test methods . 3
8.1 Thin-Layer chromatographic identification .3
8.2 Determination of characteristic chromatogram .3
8.3 Determination of marker compound content .3
8.4 Determination of ethanol-soluble extractives .3
8.5 Determination of water or moisture content .3
8.6 Determination of particle size and particle size distribution .3
8.7 Dissolution or disintegration test .4
8.8 Estimation of uniformity of dosage unit .4
8.9 Determination of heavy metals and harmful elements content .4
8.10 Determination of pesticide residues content .4
8.11 Microorganism test .4
9 Storage . 4
Annex A (informative) Salvia miltiorrhiza root and rhizome aqueous extract granules
manufacturing procedures . . 5
Annex B (informative) Safety requirements in different pharmacopoeias and standards . 7
Annex C (informative) Thin-Layer chromatographic identification . 9
Annex D (informative) Determination of characteristic chromatogram .11
Annex E (informative) Determination of marker compound content .13
Annex F (informative) Determination of ethanol-soluble extractives .15
Bibliography .16

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
Salvia miltiorrhiza root and rhizome (the Chinese Pinyin name: Danshen) has been used as traditional Chinese
medicine for over 2 500 years and has been developed into various herbal medicinal products in many
countries. Salvia miltiorrhiza root and rhizome aqueous extract granules are alternative forms of dosage
for Salvia miltiorrhiza decoction pieces, which are obtained through modern pharmaceutical technology
of extraction, concentration, drying and granulation. Salvia miltiorrhiza root and rhizome aqueous extract
granules are well-suited for modern technological applications because they can be dosed accurately, quality
controllable, ready-to-take, and easy to store, thereby replacing difficult dose calculation, poor portability,
and longer decoction for Salvia miltiorrhiza decoction pieces.
ISO 21314 and ISO 23419 provide references for the quality assurance of Salvia miltiorrhiza root and rhizome
aqueous extract granules. However, the manufacturing technology and quality control of Salvia miltiorrhiza
root and rhizome aqueous extract granules have unique characteristics and requirements. Therefore, it is
important to establish technical specifications for manufacturing technology and quality requirements
of Salvia miltiorrhiza root and rhizome aqueous extract granules, to ensure their quality and safety, in
accordance with international standards.

v
International Standard ISO 21756:2026(en)
Traditional Chinese medicine — Salvia miltiorrhiza root and
rhizome aqueous extract granules
1 Scope
This document specifies the technical requirements for the quality and safety of industrial manufacturing
procedures and quality of Salvia miltiorrhiza root and rhizome aqueous extract granules. It is applicable to
Salvia miltiorrhiza root and rhizome aqueous extract granules that are sold and used in international trade.
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 19609-1, Traditional Chinese medicine — Quality and safety of raw materials and finished products made
with raw materials — Part 1: General requirements
ISO 21314, Traditional Chinese medicine — Salvia miltiorrhiza root and rhizome
ISO 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by gas
chromatography
ISO 22467, Traditional Chinese medicine — Determination of microorganisms in natural products
ISO 23419, Traditional Chinese medicine — General requirements for manufacturing procedures and quality
assurance of granules
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
granule
coated or uncoated small grains which range from approximately 0,2 mm to 4 mm in diameter, made from a
uniform mixture of powdered extract and excipients
[SOURCE: ISO 23419: 2021, 3.3, modified — Notes to entry removed.]
3.2
extract
liquid preparation obtained by using water as a solvent for medicinal plants
[SOURCE: ISO 19617: 2018, 3.10, modified — The definition of "preparation" has been specified.]

3.3
dry powder
fine particles obtained by drying concentrated extract (3.2)
3.4
dry paste rate
ratio of the amount of dry powder (3.3) obtained by extracting, concentrating, and drying to the amount of
decoction pieces as starting materials
4 Requirements of manufacturing procedures
a) The specification of the Salvia miltiorrhiza root and rhizome raw materials shall conform to the
requirements of ISO 21314.
b) One gram of Salvia miltiorrhiza root and rhizome aqueous extract granules is equivalent to 2 g of Salvia
miltiorrhiza decoction pieces.
NOTE For Salvia miltiorrhiza root and rhizome aqueous extract granules manufacturing procedures, see Annex A.
5 Description
Yellowish-brown to brown granules with a slight odour, and slightly bitter and astringent taste.
6 Qualitative identification
6.1 Thin-Layer chromatographic (TLC) identification
The spot in the TLC with the test solution corresponds in position and colour to the spot obtained with
the reference herbal solution of Salvia miltiorrhiza and the reference standard solution of salvianolic acid B
(C H O ).
36 30 16
6.2 Characteristic chromatogram
The characteristic chromatogram of the test sample should present 8 characteristic peaks, and the
corresponding peak of reference salvianolic acid B is S-peak. The relative retention time of characteristic
peaks 1 to 8 calculated should be within ±10 % of the specified value.
6.3 Marker compound
The content of salvianolic acid B (C H O ) should be between 28,0 mg/g and 59,0 mg/g.
36 30 16
6.4 Determination of ethanol-soluble extractives
Ethanol-soluble extractives should not be less than 9,3 %.
6.5 Determination of water or moisture content
Water or moisture content in percentage mass should not be more than 8,0 %.
6.6 Particle size and particle size distribution
The particle size distributions are specified in ISO 23419.

6.7 Dissolution or disintegration
The dissolution or disintegration test shall be determined and shall meet the requirements specified in
ISO 23419.
6.8 Uniformity of dosage unit
The uniformity of dosage units should meet the requirements of ISO 19609-1.
7 Requirements of safety assurance
The safety requirements of Salvia miltiorrhiza root and rhizome and Salvia miltiorrhiza root and rhizome
aqueous extract granules in different pharmacopoeias and standards are shown in Annex B.
7.1 Heavy metals and harmful elements
The content of lead, cadmium, arsenic, mercury and copper shall be determined.
7.2 Pesticide residues
The content of pesticide residues such as DDT (dichloro-diphenyl-trichloroethane), BHC (benzene
hexachloride) should be determined.
7.3 Microorganism
The total number of aerobic bacteria, molds and yeasts shall be determined, and Escherichia coli shall not be
detected.
8 Test methods
8.1 Thin-Layer chromatographic identification
See Annex C for additional information.
8.2 Determination of characteristic chromatogram
See Annex D for additional information.
8.3 Determination of mar
...