ISO 7835:2026

• 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
• 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: 07-Aug-2026
• Due Date: 19-Jul-2027
• Completion Date: 07-Aug-2026

Overview

ISO 7835: Traditional Chinese Medicine - Schisandra chinensis Fruit is an international standard developed by ISO/TC 249/SC 1 for ensuring the quality, safety, and authenticity of Schisandra chinensis fruit as used in traditional Chinese medicine. This standard specifies the minimum requirements and test methods for Schisandra chinensis fruit derived from Schisandra chinensis (Turcz.) Baill. It covers products intended for use as medicinal materials in international trade, supporting harmonized global quality benchmarks.

Schisandra chinensis, known as "wu wei zi" in China, "gomishi" in Japan, and "omija" in Korea, has long-standing therapeutic applications. The fruit is used for its various pharmacological activities and appears in notable pharmacopoeias worldwide. ISO 7835 is designed to help prevent adulteration-particularly with Schisandra sphenanthera-and to ensure consistent quality for consumers and practitioners.

Key Topics

• Product Description: Covers macroscopic and microscopic characteristics to confirm the identity of Schisandra chinensis fruit, including its distinctive shape, color, and internal structure.
• Quality Requirements: Specifies cleanliness, absence of foreign matter, and exclusion of contaminants such as insects, molds, and pollution.
• Testing Methods: Details methods for the identification of marker compounds (e.g., schisandrin, gomisin A, gomisin N), moisture determination, total ash, heavy metals, pesticide residues, and sulfur dioxide.
• Differentiation: Provides criteria to distinguish Schisandra chinensis fruit from similar species such as Schisandra sphenanthera, reducing the risk of adulteration.
• Packaging and Labeling: Sets requirements for packaging, storage, and labeling, ensuring proper traceability and consumer information.
• Compliance Reporting: Outlines the structure of test reports, including identification, test methods used, results, and anomalies.

Applications

ISO 7835 is applicable to a broad range of stakeholders in the traditional medicine and herbal supplement industries:

• Manufacturers and Exporters: Ensures Schisandra chinensis fruit products meet quality benchmarks, facilitate international trade, and reduce barriers related to differing regional standards.
• Regulatory Authorities: Provides a harmonized reference for inspection and regulation, supporting public health, consumer safety, and fair trade practices in herbal products.
• Pharmacopoeias and Quality Assurance Bodies: Supports the inclusion of Schisandra chinensis fruit in official pharmacopoeia monographs and quality control protocols globally.
• Traditional Medicine Practitioners: Assures the authenticity and potency of medicinal materials for clinical application.
• Retailers and Importers: Enhances supply chain transparency and assures product quality and compliance with international requirements.

Related Standards

To ensure comprehensive quality control, ISO 7835 references and complements several other ISO standards relevant to traditional Chinese medicine and herbal products:

• ISO 18664 – Determination of heavy metals in herbal medicines
• ISO/TS 21310 – Microscopic examination of medicinal herbs
• ISO 21371 – Labelling requirements for oral or topical herbal products
• ISO 22217 – Storage requirements for raw materials and decoction pieces
• ISO 22258 – Determination of pesticide residues by gas chromatography
• ISO 22590 – Determination of sulfur dioxide in natural products by titration
• ISO 23723 – General requirements for herbal raw materials and materia medica

ISO 7835 is aligned with international pharmacopoeias-including those from China, Japan, Korea, Europe, and the United States-facilitating global trade and quality management in the herbal and traditional medicine sectors.

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Keywords: ISO 7835, Schisandra chinensis, traditional Chinese medicine, herbal quality control, international standard, authentication, safety, test methods, herbal trade, pharmacopoeia

International
Standard
ISO 7835
First edition
Traditional Chinese medicine —
2026-08
Schisandra chinensis fruit
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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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
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This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, Subcommittee SC 1,
Traditional Chinese medicine.
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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
...