ISO 7835:2026
(Main)Traditional Chinese medicine — Schisandra chinensis fruit
General Information
- Abstract
This document specifies the minimum requirements and test methods for Schisandra chinensis fruit which is derived from Schisandra chinensis (Turcz.) Baill. It is applicable to Schisandra chinensis fruit that is sold and used as a medicinal material in international trade, including Chinese materia medica.
- Status
- Published
- Publication Date
- 06-Aug-2026
- Technical Committee
- ISO/TC 249 - Traditional Chinese medicine
- Drafting Committee
- ISO/TC 249 - Traditional Chinese medicine
- Current Stage
- 6060 - International Standard published
- Start Date
- 07-Aug-2026
- Due Date
- 19-Jul-2027
- Completion Date
- 07-Aug-2026
Overview
ISO 7835:2026 – Traditional Chinese Medicine - Schisandra chinensis Fruit is an international standard developed by ISO/TC 249 for the quality and safety of Schisandra chinensis fruit. This document specifies minimum requirements and test methods for Schisandra chinensis fruit (also known as wu wei zi, gomishi, or omija) that is traded and used as a medicinal material globally. The standard is designed to support quality consistency, safety, and authenticity in the international trade of this traditional herbal medicine, ensuring its effectiveness and regulatory compliance.
Key Topics
- Minimum Quality Requirements
The standard outlines physical and chemical characteristics, including moisture and total ash content, that Schisandra chinensis fruit must meet for medicinal use. - Identification and Differentiation
It details methods for authenticating Schisandra chinensis fruit, distinguishing it from the often-adulterated Schisandra sphenanthera fruit through both morphological and chemical markers. - Marker Compounds
Identification and quantification of key marker compounds-schisandrin, gomisin A, and gomisin N-are specified, supporting precise quality control. - Safety Parameters
Test limits for heavy metals (e.g., lead, arsenic, cadmium, mercury), pesticide residues, and sulfur dioxide are established to ensure consumer safety. - Sampling and Testing Methods
Procedures for sampling and laboratory analysis are referenced or described in detail to ensure uniform application across laboratories and countries. - Packaging, Storage, and Labelling
Requirements for packaging materials, storage conditions, and comprehensive marking/labelling support traceability and product integrity.
Applications
- International Trade and Regulatory Compliance
ISO 7835:2026 helps producers, exporters, importers, and regulators ensure that dried Schisandra chinensis fruit meets internationally accepted quality and safety specifications, promoting fair trade and market access. - Quality Assurance in Herbal Medicine Manufacturing
Manufacturers of traditional Chinese medicine, dietary supplements, and phytopharmaceuticals use the standard for incoming raw material verification to maintain safety and efficacy in finished products. - Prevention of Adulteration
The standard supports the authentication of Schisandra chinensis fruit, reducing the risk of adulteration with Schisandra sphenanthera and ensuring clinical and pharmacological consistency. - Reference for National Pharmacopoeias and Regulatory Bodies
National standards bodies and pharmacopoeias use ISO 7835:2026 as a reference for developing local requirements for Schisandra chinensis fruit. - Harmonizing Quality Across Markets
Adopting this standard contributes to globally harmonized requirements-streamlining documentation, inspection, and acceptance procedures in cross-border supply chains.
Related Standards
For comprehensive quality control and compliance, the following ISO standards are referenced in ISO 7835:2026:
- ISO 18664 – Determination of heavy metals in traditional Chinese medicine
- ISO 21310 – Microscopic examination of medicinal herbs
- ISO 21371 – Labelling requirements for oral or topical TCM products
- ISO 22217 – Storage requirements for raw materials and decoction pieces
- ISO 22258 – Determination of pesticide residues in natural products
- ISO 22590 – Determination of sulfur dioxide in natural products
- ISO 23723:2021 – General requirements for herbal raw materials and materia medica
Practical Value
ISO 7835:2026 offers a unified framework for controlling the quality and safety of Schisandra chinensis fruit in the herbal medicine supply chain, reducing the risks of contamination and substitution. It benefits producers, importers, manufacturers, regulators, and consumers through enhanced confidence in product identity, efficacy, and safety in traditional Chinese medicine and related fields.
By adopting ISO 7835:2026, stakeholders facilitate smoother international trade, improved traceability, and compliance with both global and regional regulations for Schisandra chinensis fruit.
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Frequently Asked Questions
ISO 7835:2026 is a standard published by the International Organization for Standardization (ISO). Its full title is "Traditional Chinese medicine — Schisandra chinensis fruit". This standard covers: This document specifies the minimum requirements and test methods for Schisandra chinensis fruit which is derived from Schisandra chinensis (Turcz.) Baill. It is applicable to Schisandra chinensis fruit that is sold and used as a medicinal material in international trade, including Chinese materia medica.
This document specifies the minimum requirements and test methods for Schisandra chinensis fruit which is derived from Schisandra chinensis (Turcz.) Baill. It is applicable to Schisandra chinensis fruit that is sold and used as a medicinal material in international trade, including Chinese materia medica.
ISO 7835:2026 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 7835:2026 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 7835
First edition
Traditional Chinese medicine —
2026-08
Schisandra chinensis fruit
Reference number
© ISO 2026
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ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Description . . 2
5 Requirements and recommendations . 2
5.1 General characteristics .2
5.2 Macroscopic characteristics .2
5.3 Microscopic characteristics .3
5.4 Moisture .3
5.5 Total ash .4
5.6 Identification of Schisandra chinensis fruit .4
5.7 Differentiation of Schisandra chinensis fruit from Schisandra sphenanthera fruit .4
5.8 Content of marker compounds .4
5.9 Heavy metals .4
5.10 Pesticide residues .4
5.11 Sulfur dioxide . .4
6 Sampling . 4
7 Test methods . 5
7.1 Macroscopic identification .5
7.2 Microscopic identification .5
7.3 Determination of moisture content .5
7.4 Determination of total ash content .5
7.5 Identification of schisandrin, gomisin A and gomisin N .5
7.6 Determination of schisandrin, gomisin A and gomisin N content .5
7.7 Determination of heavy metals .5
7.8 Determination of pesticide residues .5
7.9 Determination of sulfur dioxide .5
8 Test report . 5
9 Packaging, storage and transportation . 6
10 Marking and labelling . 6
Annex A (informative) Identification of schisandrin, gomisin A and gomisin N . 7
Annex B (Informative) Determination of schisandrin, gomisin A and gomisin N content . 9
Annex C (informative) Differentiation of Schisandra chinensis fruit from Schisandra sphenathera
fruit .12
Annex D (informative) Reference information for national and regional requirements .15
Bibliography .16
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
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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)
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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
Schisandra chinensis fruit is a well-known traditional herbal medicine for thousands of years. Schisandra
chinensis fruit has been used for the treatment of chronic cough and asthma, diabetes, and urinary tract
disorders. Pharmacological studies have revealed that Schisandra chinensis fruit possesses various biological
activities, including hepatoprotective, anti-inflammatory, antioxidant and antitumor activities.
Schisandra chinensis fruit has been officially documented as a traditional herbal medicine in the
[2] [3]
pharmacopoeias of several countries, including China (named wu wei zi), Japan (named gomishi), and
[1]
Korea (named omija), as a traditional herbal medicine. Recently, the monograph of Schisandra chinensis
fruit has also been included in the European pharmacopoeia and the United States Pharmacopoeia, where it
is regulated as a dietary supplement.
The active medicinal constituents of Schisandra chinensis fruit contribute to its high market demand and
utilization. Given the extensive cultivation and widespread use of this botanical, products in the herbal
market are frequently adulterated with Schisandra sphenanthera fruit. This substitution occurs due to the
morphological similarity between the two species and the lower cost of Schisandra sphenanthera fruit.
Although the two Schisandra species differ significantly in their chemical profiles and biological activities,
they are both commonly referred to as “Schisandra fruit” in commercial trade, leading to inconsistent
quality in industrial applications.
Therefore, the establishment of an international standard for Schisandra chinensis fruit is necessary to
support the clinical effectiveness, safety and quality consistency of this valuable traditional herbal medicine
in international trade.
As national implementation can differ, national standards bodies are invited to modify the values given in
5.5 in their national standards. Examples of national and regional values are given in Annex D.
v
International Standard ISO 7835:2026(en)
Traditional Chinese medicine — Schisandra chinensis fruit
1 Scope
This document specifies the minimum requirements and test methods for Schisandra chinensis fruit which is
derived from Schisandra chinensis (Turcz.) Baill.
It is applicable to Schisandra chinensis fruit that is sold and used as a medicinal material in international
trade, including Chinese materia medica.
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 21310, Traditional Chinese medicine — Microscopic examination of medicinal herbs
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:
— IEC Electropedia: available at https:// www .iso .org/ obp
— ISO Online browsing platform: available at https:// www .electropedia .org/
3.1
Schisandra chinensis fruit
dried and ripe fruit from Schisandra chinensis (Turcz.) Baill. (Fam. Magnoliaceae).
3.2
Schisandra sphenanthera fruit
dried and ripe fruit from Schisandra sphenanthera Rehd. et Wils. (Fam. Magnoliaceae).
3.3
final sample
sample for the test required in this document
[SOURCE: ISO 23193:2020, 3.4]
4 Description
Schisandra chinensis fruit is shown in Figure 1.
Key
A fruiting branch of Schisandra chinensis (Turcz.) Baill.
B fruits of Schisandra chinensis (Turcz.) Baill.
1 fruit
2 seed
3 peduncle
Figure 1 — Structure of the plant of Schisandra chinensis fruit
5 Requirements and recommendations
5.1 General characteristics
The following requirements shall be met before sampling.
a) Schisandra chinensis fruit shall be clean and free from foreign matter.
b) The presence of living insects, moulds and external contaminants which are visible to the naked eye
shall not be permitted.
5.2 Macroscopic characteristics
a) The dried fruit is of an irregular and flat globular shape. The diameter of the dried fruit containing one
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