ISO 13619:2024

Traditional Chinese medicine - Gardenia jasminoides fruit

This document specifies the quality and safety requirements and test methods of Gardenia jasminoides fruit, which is derived from the dried fruit of Gardenia jasminoides Ellis (Fam. Rubiaceae). This document is applicable to Gardenia jasminoides fruit that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal material) and decoction pieces derived from this plant.

Médecine traditionnelle chinoise — Fruit du Gardenia jasminoides

General Information

• Status: Published
• Publication Date: 21-May-2024
• 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: 22-May-2024
• Due Date: 04-Apr-2025
• Completion Date: 22-May-2024

Overview

ISO 13619:2024 - Traditional Chinese medicine - Gardenia jasminoides fruit is the first edition International Standard that defines quality and safety requirements and test methods for the dried fruit of Gardenia jasminoides Ellis (Fam. Rubiaceae). Applicable to whole Chinese materia medica and decoction pieces used and traded internationally, the standard harmonizes morphological, chemical and safety criteria to support consistent quality for medicinal use and commerce.

Key topics and technical requirements

• Identification and description
  • Macroscopic features: ovate to elliptical fruit, six longitudinal ridges, persistent calyx; colour ranges from yellowish to brownish‑red; taste bitter, odour slight.
  • Dimensions: length 15–35 mm, diameter 10–15 mm.
  • Microscopic characteristics: sclereids, endocarp fibres, calcium oxalate crystals and other diagnostic powder traits (illustrated in the standard).
• Quality limits
  • Moisture ≤ 13.0% (mass fraction)
  • Total ash ≤ 6.0% (mass fraction)
• Chemical and analytical tests
  • TLC identification: extracts must show matching spot/band colour and position to reference solution.
  • Marker compound analysis (Annex B covers geniposide determination).
  • Safety testing for heavy metals and pesticide residues (references to ISO 18664 and ISO 22258).
• Other requirements
  • Sampling, test methods, test reporting, packaging, storage and labelling rules are specified to support traceability and compliance.
  • Annexes provide TLC procedures, geniposide assay details, differentiation from related varieties, and national/regional requirement comparisons.

Practical applications and users

ISO 13619:2024 is intended for:

• Manufacturers and processors of Gardenia jasminoides fruit and decoction pieces - to implement consistent raw‑material quality controls.
• Testing laboratories and QA teams - for validated methods (TLC, moisture, ash, marker assays, heavy metals, pesticide screens).
• Importers, exporters and traders - to ensure products meet harmonized international specifications for trade.
• Regulatory agencies and pharmacopeial bodies - to reference a clear international benchmark for safety and labelling.
• Practitioners of Traditional Chinese Medicine and formulators - to verify material identity and potency (e.g., geniposide content) for clinical use. Practical uses include medicinal quality assurance, conformity assessment for international trade, and standardised reference for national standard development.

Related standards

Normative references cited in ISO 13619:2024 include:

• ISO 18664 (heavy metals),
• ISO/TS 21310 (microscopic examination),
• ISO 21371 (labelling),
• ISO 22217 (storage for raw materials and decoction pieces),
• ISO 22258 (pesticide residues by GC),
• ISO 23723:2021 (general requirements for herbal raw material).

Keywords: ISO 13619:2024, Gardenia jasminoides fruit, traditional Chinese medicine standard, quality and safety requirements, test methods, geniposide, TLC identification, heavy metals, pesticide residues.

Standards Content (Sample)

International
Standard
ISO 13619
First edition
Traditional Chinese medicine —
2024-05
Gardenia jasminoides fruit
Médecine traditionnelle chinoise — Fruit du Gardenia
jasminoides
Reference number
© ISO 2024
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.
ISO copyright office
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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 . 1
5 Requirements and recommendations . 2
5.1 General .2
5.2 Morphological features .2
5.2.1 Appearance .2
5.2.2 Colour .3
5.2.3 Dimensions .3
5.2.4 Fracture .3
5.2.5 Odour and taste .3
5.3 Microscopic characteristics .3
5.4 Moisture .4
5.5 Total ash .4
5.6 Thin-layer chromatogram (TLC) identification .4
5.7 Marker compound(s) .4
5.8 Heavy metals .4
5.9 Pesticide residues .4
6 Sampling . 5
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 Thin-layer chromatogram (TLC) identification .5
7.6 Determination of marker compound(s).5
7.7 Determination of heavy metal contents .5
7.8 Determination of pesticide residue contents .5
8 Test report . 5
9 Packaging, storage and transportation . 6
10 Marking and labeling . 6
Annex A (informative) Thin-layer chromatogram (TLC) identification . 7
Annex B (informative) Determination of geniposide contents . 9
Annex C (informative) Reference information and methods for differentiating Gardenia
jasminoides Ellis and Gardenia jasminoides var. grandiflora Nakai .11
Annex D (informative) Reference information of Gardenia jasminoides fruit in different national
and regional requirements .12
Bibliography .13

iii
Foreword
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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
Gardenia jasminoides fruit, the dried fruit of Gardenia jasminoides Ellis (Fam. Rubiaceae), is widely used in
China, Japan, Korea, other Southeast Asian countries and North America, and has a long application history
as herbal medicine. It is commonly used for draining fire and treatment of certain febrile conditions, cooling
blood and eliminating stasis to activate blood circulation. Clinically, owing to its medicinal properties, it
plays an important role in diuretic, cholagogue, anti-inflammatory, antioxidant and antipyretic effects.
Gardenia jasminoides fruit has also been applied as an important natural colourant, such as gardenia yellow
and gardenia blue pigments in China, Japan, Korea, India and North America. Recently, there has been an
increasing demand for Gardenia jasminoides fruit in China and elsewhere; the average annual demand for
Gardenia jasminoides fruit between 2015 and 2020 was about 1 500 t. Gardenia jasminoides fruit is ranked
no. 59 in the priority list of single herbal medicines for developing standards in ISO/TR 23975.
Gardenia jasminoides fruit has been widely cultivated as a medicinal and ornamental plant in the tropical
and subtropical regions of the world, growing on mountain slopes or at the roadside. However, the quality
of Gardenia jasminoides fruit cultivated by different areas is quite different. In addition, though Gardenia
jasminoides fruit has been recorded in several pharmacopeias and standards, specifications and quality
requirements in these standards are varied. Thus, there is a clear and urgent need to develop an International
Standard for harmonizing these existing standards, as well as ensuring the safety and effectiveness of
Gardenia jasminoides fruit.
As national implementation can differ, national standards bodies are invited to modify the values given in
5.4 and 5.5 in their national standards. Examples of national and regional values are given in Annex D.

v
International Standard ISO 13619:2024(en)
Traditional Chinese medicine — Gardenia jasminoides fruit
1 Scope
This document specifies the quality and safety requirements and test methods of Gardenia jasminoides fruit,
which is derived from the dried fruit of Gardenia jasminoides Ellis (Fam. Rubiaceae).
This document is applicable to Gardenia jasminoides fruit that are sold and used as natural medicines in
international trade, including Chinese materia medica (whole medicinal material) 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/TS 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 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:
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