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

ISO 7835:2026 is an International Standard published by ISO for Schisandra chinensis fruit, a traditional Chinese medicine raw material. It specifies minimum requirements and test methods for the dried, ripe fruit of Schisandra chinensis (Turcz.) Baill. when it is sold and used as a medicinal material in international trade, including Chinese materia medica. This is the first edition.

What does ISO 7835:2026 specify?

ISO 7835:2026 specifies how to recognize, test and handle Schisandra chinensis fruit so that buyers, laboratories and suppliers can judge identity and quality in a consistent way. The document covers the material itself, the test methods, the test report, packaging, storage, transportation, marking and labelling.

The standard is organized into 10 clauses and 4 informative annexes.

Annex	What it covers
Annex A	Identification of schisandrin, gomisin A and gomisin N by thin-layer chromatography (TLC)
Annex B	Determination of schisandrin, gomisin A and gomisin N content by high-performance liquid chromatography (HPLC)
Annex C	Differentiation of Schisandra chinensis fruit from Schisandra sphenanthera fruit
Annex D	Reference information for national and regional requirements

What are the key requirements of ISO 7835:2026?

Identity and appearance

ISO 7835:2026 requires the fruit to be clean, free from foreign matter, and free from living insects, moulds and visible external contaminants before sampling. It also gives macroscopic and microscopic descriptions of the dried fruit in Clauses 5.2 and 5.3, including shape, colour, surface features and internal structure.

In practice, this is the first screening step for receiving and sorting material. If the fruit does not match the described appearance or shows contamination, it should be investigated before any further testing.

Quality limits and chemical control

ISO 7835:2026 requires determination of moisture and sets a limit for total ash in Clause 5.5. The document also requires determination of marker compounds, heavy metals, pesticide residues and sulfur dioxide in Clauses 5.8 to 5.11. The foreword notes that national standards bodies may adapt the values in 5.5, and Annex D gives examples of national and regional requirements.

In practice, this means the standard is not only about identity. It also drives the chemical checks that matter for shelf life, mineral contamination, agricultural residues and processing residue control.

Identification and differentiation from adulteration

ISO 7835:2026 allows identity to be confirmed by macroscopic features, microscopic features, or a TLC or HPLC fingerprint that shows characteristic compounds and excludes known adulterations. Clause 5.6 specifically names schisandrin, gomisin A and gomisin N as marker compounds, and says the test solution must match the reference standards in spot position and colour for TLC, or in retention time and UV spectrum for HPLC.

Clause 5.7 focuses on differentiating Schisandra chinensis fruit from Schisandra sphenanthera fruit. It first uses morphology, then TLC or HPLC, supported by Annex C.

In practice, this is the main authenticity control. It helps prevent substitution of a lower-cost species that looks similar but has a different chemical profile.

Sampling and test methods

ISO 7835:2026 requires sampling in accordance with ISO 23723:2021, Clause 8. Clause 7.1 says macroscopic identification uses a test sample of not less than 250 g, observed with the naked eye and measured for length and width.

For the laboratory work, Clause 7 points to named methods for each item: microscopic identification, moisture, total ash, heavy metals, pesticide residues and sulfur dioxide. Annex A and Annex B provide the detailed TLC and HPLC procedures for the marker compounds.

In practice, this gives laboratories a clear pathway from sample collection to test execution, which helps avoid disputes over how the result was obtained.

Test reporting, packaging and labelling

Clause 8 requires the test report to identify the sample, state the sampling method, identify the test method, give the results, record any optional operating details or incidents, note anomalies and give the test date. Clause 9 requires packaging that does not transmit odour or flavour and does not damage the product, and it refers storage conditions to ISO 22217. Clause 10 requires marking and labelling in accordance with ISO 21371, including the product name, Latin scientific name, quality features, origin, producer or supplier details, production date, batch number, expiry date and storage method.

In practice, these clauses matter for traceability, batch release and transport control.

What terms does ISO 7835:2026 define?

• Schisandra chinensis fruit - The dried and ripe fruit of Schisandra chinensis (Turcz.) Baill., which is the material covered by the standard.
• Schisandra sphenanthera fruit - The dried and ripe fruit of Schisandra sphenanthera Rehd. et Wils., used as the comparison species in the differentiation clauses.
• final sample - The sample prepared for the test required in this document.
• thin-layer chromatography (TLC) - A chromatographic identification method used in the annexes to compare the test solution with reference substances by spot position and colour.
• high-performance liquid chromatography (HPLC) - A chromatographic method used in the standard for fingerprinting, identification and content determination by comparing peaks with reference standards.
• marker compounds - The named compounds schisandrin, gomisin A and gomisin N, which are used to confirm identity and measure content.

Who uses ISO 7835:2026?

ISO 7835:2026 is used by laboratories, quality control teams, suppliers, traders, importers and buyers working with traditional Chinese medicine and other medicinal material trade in Schisandra chinensis fruit. It is also relevant to manufacturers and inspectors who need to verify identity, check contamination, separate genuine material from Schisandra sphenanthera fruit, and document results for batch acceptance, release or procurement.

The standard is practical for anyone who handles raw herbal material and needs a shared basis for inspection, sampling, testing, labelling and storage.

Which standards are used with ISO 7835:2026?

Standard	What it contributes
ISO 18664	Method for determining heavy metals in herbal medicines used in Traditional Chinese Medicine
ISO 21310	Microscopic examination of medicinal herbs
ISO 21371	Labelling requirements of products intended for oral or topical use
ISO 22217	Storage requirements for raw materials and decoction pieces
ISO 22258	Determination of pesticide residues in natural products by gas chromatography
ISO 22590	Determination of sulfur dioxide in natural products by titration
ISO 23723:2021	General requirements for herbal raw material and materia medica, including sampling and some test methods

Clause 7.2 also points to ISO/TS 21310 for microscopic identification.

What does the ISO 7835:2026 document contain?

ISO 7835:2026 contains a plant and fruit description, a list of requirements and recommendations, sampling rules, test methods, reporting rules, packaging and storage guidance, and labelling requirements. It also includes figures showing the fruit structure and microscopic characteristics.

The informative annexes provide the practical laboratory detail. Annex A gives the TLC preparation steps and a reference chromatogram for schisandrin, gomisin A and gomisin N. Annex B gives the HPLC preparation, system suitability, chromatographic conditions, calculation formulas and a reference chromatogram. Annex C gives comparison material for distinguishing Schisandra chinensis fruit from Schisandra sphenanthera fruit, using morphology, TLC and HPLC. Annex D summarizes example requirements from national and regional pharmacopoeias.

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
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This document was prepared by Technical Committee ISO/TC 249, Traditional medicine, Subcommittee SC 1,
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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
...