Traditional Chinese medicine — Cultivated Cistanche deserticola stem

This document specifies the quality and safety requirements for cultivated Cistanche deserticola stem derived from the plant of Cistanche deserticola Y.C. Ma. It is applicable to cultivated Cistanche deserticola stem that is sold as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

Médecine traditionnelle chinoise — Tige de Cistanche deserticola cultivée

General Information

Status
Published
Publication Date
19-Mar-2026
Current Stage
6060 - International Standard published
Start Date
20-Mar-2026
Due Date
06-May-2027
Completion Date
20-Mar-2026

Overview

ISO/FDIS 25115:2025 - Traditional Chinese medicine - Cultivated Cistanche deserticola stem provides internationally harmonized quality and safety requirements for cultivated Cistanche deserticola Y.C.Ma stems. The standard applies to cultivated material sold as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces. Prepared by ISO/TC 249 (Traditional medicine), SC 1/WG 1, this FDIS consolidates testing, labeling and handling practices to support safe commerce and consistent product quality.

Key topics and technical requirements

The standard organizes requirements across descriptive, analytical and administrative elements. Major technical topics include:

  • Descriptions and macroscopic characteristics for visual identification of cultivated Cistanche deserticola stem.
  • Physical and chemical quality tests such as moisture content, total ash and dilute ethanol‑soluble extractives.
  • Identification and marker compound analysis - includes Thin‑Layer Chromatography (TLC) and determination of marker compounds (for example, echinacoside and verbascoside are addressed in the informative annexes).
  • Safety limits and testing for heavy metals and pesticide residues.
  • Sampling and test methods with guidance on how to collect representative lots and report results.
  • Packaging, storage, transportation, marking and labelling requirements to preserve quality during trade.
  • Informative annexes providing detailed procedures: extractives determination, TLC identification, quantitative assays for marker compounds, national/regional requirement comparisons, and methods to differentiate Cistanche species (C. deserticola, C. tubulosa, C. salsa).

Note: the standard provides methods and reference information rather than prescribing a single national limit - national bodies may adapt values in their own implementation.

Applications and who uses it

ISO/FDIS 25115 is useful for:

  • Producers and cultivators who need to demonstrate cultivated-source certification and meet export quality standards.
  • Quality control and analytical laboratories performing moisture, ash, TLC, marker compound, heavy metal and pesticide tests.
  • Pharmaceutical, herbal product and supplement manufacturers sourcing cultivated Cistanche for formulations or decoction pieces.
  • Regulators, customs and traders applying harmonized criteria for import/export of traditional Chinese medicine.
  • Researchers and standards developers working on species differentiation, chemical characterization and sustainable cultivation.

Practical benefits include improved traceability, protection of wild stocks by promoting cultivated material, consistent product quality for consumers, and reduced trade barriers through harmonized test methods.

Related standards

  • References to national pharmacopeias (Chinese, Japanese, Korean) are noted and compared in annexes.
  • ISO/TC 249 publications on traditional medicine provide complementary guidance for other herbal materials and testing methods.

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ISO 25115:2026 - Traditional Chinese medicine — Cultivated Cistanche deserticola stem

Release Date:20-Mar-2026
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Frequently Asked Questions

ISO 25115:2026 is a standard published by the International Organization for Standardization (ISO). Its full title is "Traditional Chinese medicine — Cultivated Cistanche deserticola stem". This standard covers: This document specifies the quality and safety requirements for cultivated Cistanche deserticola stem derived from the plant of Cistanche deserticola Y.C. Ma. It is applicable to cultivated Cistanche deserticola stem that is sold as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

This document specifies the quality and safety requirements for cultivated Cistanche deserticola stem derived from the plant of Cistanche deserticola Y.C. Ma. It is applicable to cultivated Cistanche deserticola stem that is sold as natural medicine in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from this plant.

ISO 25115:2026 is classified under the following ICS (International Classification for Standards) categories: 11.120.10 - Medicaments. The ICS classification helps identify the subject area and facilitates finding related standards.

ISO 25115:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.

Standards Content (Sample)


International
Standard
ISO 25115
First edition
Traditional Chinese medicine —
2026-03
Cultivated Cistanche deserticola
stem
Médecine traditionnelle chinoise — Tige de Cistanche deserticola
cultivée
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
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: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 1
5 Requirements and recommendations . 2
5.1 General characteristics .2
5.2 Macroscopic characteristics .3
5.2.1 Appearance .3
5.2.2 Sensory identification .3
5.3 Moisture .3
5.4 Total ash .3
5.5 Thin-layer chromatography identification .3
5.6 Dilute ethanol-soluble extractives .3
5.7 Marker compounds .3
5.8 Heavy metals .3
5.9 Pesticide residues .3
6 Sampling . 3
7 Test methods . 3
7.1 Macroscopic examination .3
7.2 Determination of moisture content .4
7.3 Determination of total ash .4
7.4 Determination of dilute ethanol-solution extractives content .4
7.5 Thin-layer chromatography (TLC) identification .4
7.6 Determination of maker compound content .4
7.7 Determination of heavy metals contents .4
7.8 Determination of pesticide residues contents.4
8 Test report . 4
9 Packaging, storage and transportation . 4
10 Marking and labelling . 5
Annex A (informative) Determination of dilute ethanol-solution extractives . 6
Annex B (informative) Thin layer chromatography (TLC) identification . 7
Annex C (informative) Determination of echinacoside and verbascoside content. 9
Annex D (informative) Referenced information of national and regional requirements on
Cistanche deserticola stem .12
Annex E (informative) Reference information and methods for differentiating Cistanche
deserticola, Cistanche tubulosa and Cistanche salsa stem .13
Annex F (informative) Reference information of Cistanche tubulosa stem . 14
Bibliography .15

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 through
ISO technical committees. Each member body interested in a subject for which a technical committee
has been established has the right to be represented on that committee. International organizations,
governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely
with the International Electrotechnical Commission (IEC) on all matters of 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 document 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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and expressions
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.
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
Cistanche deserticola stem (Rou Cong Rong) is the dried stout stem of Cistanche deserticola Y.C. Ma. It
was first recorded in the book Shennong Bencao Jing, a commonly used reference for traditional Chinese
medicine. Cistanche deserticola stem has long been used in traditional Chinese medicine for its multiple
therapeutic properties (warming kidney yang, reinforcing essence and blood, relaxing bowel). Modern
pharmacological studies have shown that it has significant effects in improving renal function, enhancing
memory, preventing Alzheimer's disease, anti-aging, anti-fatigue, regulating immune function, etc. It is a
highly regarded traditional Chinese medicine with significant medicinal and economic value around the
world. The quantity of Cistanche deserticola has declined sharply due to its extensive exploitation. The
Convention on International Trade in Endangered Species of Wild Fauna and Flora classifies it as an endangered
species, which is not conducive to trade. With the increasing demand, researchers and farmers began to
study the artificial cultivation of Cistanche deserticola in the 1990s, and cultivated products have gradually
replaced wild products on the market. So far, the output of cultivated Cistanche deserticola stem has largely
met market demand, forming an industrial chain integrating planting, processing, production and sales.
From the perspective of protecting wild Cistanche deserticola, the use of cultivated Cistanche deserticola
stem is encouraged. Therefore, it is advisable to provide a certificate of cultivation for the product during
trade. Futhermore, Cistanche tubulosa and Cistanche salsa stem are also used as Cistanche herbs in some
countries. For the distinctions among the three species in terms of morphological features, chemistry and
molecular levels, see Annex E. Among them, Cistanche tubulosa stem is also explicitly included in the Chinese
Pharmacopoeia and the Japanese Pharmacopoeia, and its specific quality requirements can be found in
Annex F.
Cultivated Cistanche deserticola stem is mainly produced in the following provinces of China: Inner Mongolia,
as well as Ningxia, Gansu, Xinjiang and Qinghai with a relatively smaller volume. There is no significant
difference in the quality of Cistanche deserticola stem produced in these provinces, and it is exported to
Japan, South Korea, Southeast Asia and other regions every year, with a large international and domestic
[2]
demand. Although Cistanche deserticola stem has been recorded in Chinese Pharmacopoeia (2020 edition) ,
[4] [5]
Japanese Pharmacopoeia (18th edition) and Korean Herbal Pharmacopoeia (version 4) , these standards
are not harmonized and can be unsuitable for the purpose of international trade of cultivated Cistanche
deserticola stem. Therefore, it is of utmost urgency that the quality of cultivated Cistanche deserticola stem
be standardized throughout the world. This can benefit consumers (patients), farmers, enterprises and
companies related to the planting, management and trade of Cistanche deserticola stem.
As national implementation can differ, national standards bodies are invited to modify the values given in
5.3, 5.4 and 5.6 in their national standards. Examples of national and regional values are given in Annex D.

v
International Standard ISO 25115:2026(en)
Traditional Chinese medicine — Cultivated Cistanche
deserticola stem
1 Scope
This document specifies the quality and safety requirements for cultivated Cistanche deserticola stem
derived from the plant of Cistanche deserticola Y.C. Ma.
It is applicable to cultivated Cistanche deserticola stem that is sold as natural medicine in international trade,
including 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 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 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
Cistanche deserticola stem
dried stout stem of Cistanche deserticola Y.C. Ma with scaly leaves and spadices (in case of flowering)
removed
4 Descriptions
Cultivated Cistanche deserticola stem is shown in Figure 1.

a) Plant of Cistanche deserticola b) Transverse section of the stem c) Cultivated Cistanche desertico-
Y.C. Ma la stem
Key
1 inflorescence
2 stem
3 vascular bundle
4 thick scales
Figure 1 — Structure of cultivated Cistanche deserticola stem
5 Requirements and recommendations
5.1 General characteristics
The following requirement
...

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