ISO 21316:2019

Traditional Chinese medicine - Isatis indigotica root

This document specifies the minimum requirements and test methods for Isatis indigotica root derived from the plant Isatis indigotica Fort. It is applicable to Isatis indigotica roots that are sold as Chinese material medica (whole medicinal materials) and decoction pieces derived from this plant.

Médecine traditionnelle chinoise — Racine d’Isatis indigotica

General Information

• Status: Published
• Publication Date: 04-Feb-2019
• 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: 9092 - International Standard to be revised
• Start Date: 05-Feb-2025
• Completion Date: 13-Dec-2025

Overview

ISO 21316:2019 - Traditional Chinese medicine - Isatis indigotica root establishes international minimum requirements and test methods for dried root of Isatis indigotica Fort. It applies to whole medicinal materials (Chinese materia medica) and decoction pieces. The standard defines morphological description, chemical and physical quality limits, identification procedures and sampling/testing protocols to support safety, consistency and international trade of Isatis indigotica root used in TCM.

Key Topics and Technical Requirements

• Morphology and organoleptics
  • Appearance: cylindrical, slightly twisted, longitudinal wrinkles, lenticels and rootlet scars.
  • Colour: pale grayish-yellow to brownish-yellow.
  • Dimensions: length typically 10–20 cm; diameter 0.5–2.0 cm (measured near base).
  • Texture, fracture and odour/taste descriptors provided for macroscopic ID.
• Quantitative limits
  • Moisture ≤ 15.0%
  • Total ash ≤ 9.0%
  • Acid‑insoluble ash ≤ 2.0%
  • Ethanol‑soluble extractives ≥ 25.0%
• Chemical markers and identification
  • Marker compound: (R,S)-goitrin selected for specificity to Brassicaceae-derived Isatis.
  • Identification by thin‑layer chromatography (TLC) and quantification by HPLC as described.
• Contaminants and residues
  • Determination of heavy metals (arsenic, mercury, lead, cadmium).
  • Pesticide residue testing (examples: Benzex, DDT, quintozene) per CODEX and national MRLs.
• Sampling and test methods
  • Sampling follows WHO “Quality control methods for herbal materials” guidance with pooled and quartered samples.
  • Test methods include moisture, total ash, acid‑insoluble ash, ethanol extractives, TLC identification, HPLC marker assay, heavy metals and pesticide analyses.
• Quality assurance
  • Requirements for test reporting, packaging, storage, transportation, marking and labelling.

Applications and Who Uses It

• Herbal product manufacturers - implement standardized quality control for raw Isatis indigotica root and decoction pieces.
• Analytical laboratories - perform TLC/HPLC, ash, moisture and contaminant testing aligned with ISO 21316:2019 methods.
• Regulators and customs authorities - adopt consistent acceptance criteria for imports/exports and public health protection.
• Distributors, exporters and purchasers - verify supplier compliance to reduce adulteration (e.g., Baphicacanthis substitution) and ensure consistent clinical efficacy.
• TCM practitioners and formulators - ensure herbal materials meet recognized quality specifications.

Related Standards

• ISO 1575, ISO 1577 (ash testing for tea)
• ISO 18664 (heavy metals in TCM herbs)
• ISO 21371 (labelling for TCM products)
• Codex/CODEX and WHO guidance for pesticide and sampling methods

ISO 21316:2019 supports harmonized quality, safety and traceability of Isatis indigotica root in international trade and clinical use of traditional Chinese medicine.

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 21316
First edition
2019-02
Traditional Chinese medicine — Isatis
indigotica root
Médecine traditionnelle chinoise — Racine d’Isatis indigotica
Reference number
©
ISO 2019
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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ii © ISO 2019 – All rights reserved

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Requirements . 3
5.1 Morphological features . 3
5.1.1 Appearance . 3
5.1.2 Colour . 3
5.1.3 Dimension . 4
5.1.4 Stem residue . 4
5.1.5 Texture . 4
5.1.6 Fracture . 4
5.1.7 Odour . 4
5.2 Moisture . 4
5.3 Total ash . 4
5.4 Acid-insoluble ash . 4
5.5 Ethanol-soluble extractives . 4
5.6 Identification of maker compound . 4
5.7 Content of marker compound . 4
5.8 Heavy metals . 4
5.9 Pesticide residues . 4
6 Sampling . 5
7 Test methods . 5
7.1 Macroscopic identification . 5
7.2 Determination of moisture content . 5
7.3 Determination of total ash content. 5
7.4 Determination of acid-insoluble ash content . 5
7.5 Determination of ethanol-extractives content. 6
7.6 Thin-layer chromatogram (TLC) identification . 6
7.7 Determination of marker compound content . 6
7.8 Determination of heavy metals contents . 6
7.9 Determination of pesticide residues contents . 6
8 Test report . 6
9 Packaging, storage and transportation . 6
10 Marking and labelling . 6
Annex A (informative) Determination of ethanol-soluble extractives . 8
Annex B (informative) Thin-layer chromatogram (TLC) identification . 9
Annex C (informative) Determination of (R,S)-goitrin content .11
Annex D (informative) National and regional limits of moisture, total ash, acid-insoluble
ash, (R,S)-goitrin and ethanol-soluble extractive contents in Isatis indigotica root .13
Bibliography .14
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
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described 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
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expressions related to conformity assessment, as well as information about ISO's adherence to the
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.org/iso/foreword .html.
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 © ISO 2019 – All rights reserved

Introduction
Isatis indigotica root, dried root of Isatis indigotica Fort. (Fam. Brassicaceae), is one of the most
commonly used herbs in traditional Chinese medicine (TCM). It has a long history of use in East Asian
countries to remove heat and toxins, cool the blood and clear the throat.
Clinically, Isatis indigotica root is recognized as an important traditional Chinese herb for the prevention
and treatment of colds and malignant infectious diseases, especially SARS and H1N1. At present, Isatis
indigotica root and its processed products occupy a huge share of the international market. However,
many problems, such as different quality requirements among different countries and regions,
adulteration with Baphicacanthis root derived from the dried root and rhizome of Baphicacanthus cusia
(Nees) Bremek (Fam. Acanthaceae), and different packaging, transportation and storage conditions,
can affect the quality of Isatis indigotica root.
Therefore, the establishment of an international standard is necessary to establish the quality
requirements of Isatis indigotica root to support its clinical effectiveness and safety. This document
consists of a morphology observation of macroscopic characteristics, phytochemical indexes, and
standardized physical and chemical tests (moisture, total ash and acid-insoluble ash). Glucosinolates
with multi-bioactivities are specific compositions of the plant in the Brassicaceae family. Among them,
(R,S)-goitrin with high specificity reflects bioactivities relevant to the effects of Isatis indigotica root.
Using (R,S)-goitrin as the marker, TLC identification and HPLC assay methods are established in this
document.
As national implementation may differ, National Standards Bodies are invited to modify the values
given in 5.2, 5.3, 5.4 and 5.5 in their national standards. Examples of national and regional values are
given in Annex D.
INTERNATIONAL STANDARD ISO 21316:2019(E)
Traditional Chinese medicine — Isatis indigotica root
1 Scope
This document specifies the minimum requirements and test methods for Isatis indigotica root derived
from the plant Isatis indigotica Fort.
It is applicable to Isatis indigotica roots that are sold as Chinese material medica (whole medicinal
materials) and decoction pieces derived from this plant.
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 1575, Tea — Determination of total ash
ISO 1577, Tea — Determination of acid-insoluble ash
ISO 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in
Traditional Chinese Medicine
ISO 20409, Traditional Chinese medicine — Panax notoginseng root and rhizome
ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical use
CAC/MRL01, Maximum Residue Limits for Pesticides in Foods
CODEX STAN 229, Analysis of pesticide residues: Recommended methods
World Health Organization, Quality control methods for herbal materials: General advice on sampling
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https: //www .iso .org/obp
— IEC Electropedia: available at http: //www .electropedia .org/
3.1
root
dried root of Isatis indigotica Fort. (Fam. Brassicaceae)
3.2
batch
group of samples collected from the same particular place at the same time, no more than 5 000 kg
3.3
final sample
sample for the test required in this document
Note 1 to entry: Final samples may be packed in different materials meeting conditions for specific tests (e.g.
moisture or total ash).
4 Descriptions
Isatis indigotica root is the dried root of Isatis indigotica Fort in the family of Brassicaceae as shown in
Figur
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