ISO 22585:2022

Traditional Chinese medicine - Codonopsis pilosula root

This document specifies the minimum requirements and test methods for Codonopsis pilosula root derived from the plant of Codonopsis pilosula (Franch.) Nannf. It is applicable to Codonopsis pilosula root that is sold as Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

Médecine traditionnelle chinoise — Racine de Codonopsis pilosula

General Information

• Status: Published
• Publication Date: 29-Mar-2022
• 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: 30-Mar-2022
• Due Date: 08-Jul-2022
• Completion Date: 30-Mar-2022

Overview

ISO 22585:2022 - Traditional Chinese medicine - Codonopsis pilosula root defines minimum requirements and test methods for Codonopsis pilosula (Franch.) Nannf. root used as Chinese materia medica (whole medicinal materials) and decoction pieces. The standard addresses botanical description, quality limits, identification methods and required analytical testing to ensure consistent safety and authenticity of Codonopsis pilosula root in international trade and manufacturing.

Key topics and technical requirements

• Morphological description: macroscopic appearance, colour, dimensions (10–35 cm length, 0.4–2.0 cm diameter at base), texture, odour and taste.
• Quantitative limits:
  • Moisture: not more than 16.0%
  • Total ash: not more than 5.0%
  • Acid‑insoluble ash: not more than 2.0%
  • Ethanol‑soluble extractives: ≥ 35.0%
• Identification and marker analysis:
  • Thin‑layer chromatography (TLC) identification for marker compounds (e.g., lobetyolin) - matching spots/bands with reference solution.
  • Determination of marker compound content (see Annex C for lobetyolin details).
• Contaminants and residues:
  • Determination of heavy metals (arsenic, mercury, lead, cadmium).
  • Pesticide residues and sulfur dioxide residues testing.
• Sampling and test methods:
  • Sampling according to ISO 23723:2021.
  • References to established methods (ISO 1575, ISO 1577, ISO 18664, ISO 20409, ISO 22258, ISO 22590).
  • Informative annexes for ethanol extractives, TLC identification and lobetyolin determination.
• Documentation and handling:
  • Test report requirements (sample ID, sampling method, test methods used, results, anomalies, test date).
  • Packaging, storage and transportation, marking and labelling requirements.

Note: national bodies may adapt numeric limits (moisture, ash, extractives, marker content); Annex D provides referenced values for different regions.

Applications

• Quality control and acceptance criteria for suppliers, manufacturers and processors of Codonopsis pilosula root.
• Laboratory test protocols for analytical chemists and quality assurance teams in herbal medicine production.
• Regulatory and inspection guidance for authorities reviewing herbal imports/exports and labeling.
• Reference for procurement, storage and packaging specifications used by distributors and wholesalers.

Who should use this standard

• Herbal product manufacturers and formulators using Codonopsis pilosula root.
• Quality control and analytical laboratories handling TCM raw materials.
• National standards bodies and regulatory agencies.
• Importers/exporters, distributors and certification bodies in the Traditional Chinese medicine supply chain.

Related standards

• ISO 23723:2021 (sampling/ general requirements for herbal raw material)
• ISO 1575 / ISO 1577 (ash determinations)
• ISO 18664 (heavy metals)
• ISO 20409 (moisture determination)
• ISO 22258 (pesticide residues)
• ISO 22590 (sulfur dioxide)
• ISO 21371, ISO 22217 (labelling and storage guidance)

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 22585
First edition
2022-03
Traditional Chinese medicine —
Codonopsis pilosula root
Médecine traditionnelle chinoise — Racine de Codonopsis pilosula
Reference number
© ISO 2022
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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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 . 3
5.1 Morphological features . 3
5.1.1 Appearance . 3
5.1.2 Colour . 3
5.1.3 Dimensions . 3
5.1.4 Texture . 3
5.1.5 Odour and taste . 3
5.2 Moisture . 3
5.3 Total ash . 3
5.4 Acid-insoluble ash . 3
5.5 Ethanol-soluble extractives . 3
5.6 Thin-layer chromatogram (TLC) identification . 3
5.7 Contents of marker compound . 3
5.8 Heavy metals . 4
5.9 Pesticide residues . 4
5.10 Sulfur dioxide residues . . . 4
6 Sampling . 4
7 Test methods . 4
7.1 Macroscopic identification . 4
7.2 Determination of moisture content . 4
7.3 Determination of total ash content . 4
7.4 Determination of acid-insoluble ash content . 4
7.5 Determination of ethanol-solution extractives content . 4
7.6 Thin-layer chromatogram (TLC) identification . 4
7.7 Determination of lobetyolin content . 4
7.8 Determination of heavy metals content . 4
7.9 Determination of pesticide residues content . 4
7.10 Determination of sulfur dioxide residues content . 5
8 Test report . 5
9 Packaging, storage and transportation . 5
10 Marking and labelling . 5
Annex A (informative) Determination of ethanol-soluble extractives . 6
Annex B (informative) Thin-layer chromatogram (TLC) identification . 7
Annex C (informative) Determination of lobetyolin content . 9
Annex D (informative) Referenced values of Codonopsis pilosula root in different countries
and regions.12
Bibliography .14
iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out
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electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
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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www.iso.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
Introduction
Codonopsis pilosula root is dried root of Codonopsis pilosula (Franch.) Nannf. (Family: Campanulaceae). It
has a long history of use in East Asian countries for invigorating the stomach and spleen and benefitting
qi.
Clinically, Codonopsis pilosula root is effective for the treatment of anaemia and malnutrition. To date,
Codonopsis pilosula root occupies a huge share of the international market. However, many problems
affect the quality of Codonopsis pilosula root, such as limited wild resources, increasing demand, the high
investment cost of planting, different quality requirements among different countries and regions, and
different packaging, transportation and storage conditions. Therefore, standardization of Codonopsis
pilosula root is required.
As national implementation can differ, national standards bodies are invited to modify the values given
in 5.2, 5.3, 5.4, 5.5 and 5.7 in their national standards. Examples of national and regional values are
given in Annex D.
v
INTERNATIONAL STANDARD ISO 22585:2022(E)
Traditional Chinese medicine — Codonopsis pilosula root
1 Scope
This document specifies the minimum requirements and test methods for Codonopsis pilosula root
derived from the plant of Codonopsis pilosula (Franch.) Nannf.
It is applicable to Codonopsis pilosula root that is sold as Chinese materia 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
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 22590, Traditional Chinese medicine — Determination of sulfur dioxide in natural products by titration
ISO 23723:2021, 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
Codonopsis pilosula root
dried root of Codonopsis pilosula (Franch.) Nannf. in the family of Campanulaceaea
3.2
marker compound
chemical constituent within a medicinal herb that can be used to verify its quality
Note 1 to entry: Usually described as active ingredients or chemicals that confirm the correct botanical identity
of the starting material.
Note 2 to entry: There may be one or more marker compounds for a medicinal herb.
4 Descriptions
Codono
...