ISO 13619:2024 PDF

Name: ISO 13619:2024 — Traditional Chinese medicine — Gardenia jasminoides fruit
SKU: ISO 13619:2024
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Traditional Chinese medicine — Gardenia jasminoides fruit

Название (английский):

ISO 13619:2024

Traditional Chinese medicine — Gardenia jasminoides fruit

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 13
Дата публикации:: 22 мая 2024 г.
Издание:: ISO IS 13619 edition 1 version 1
ICS:: 11.120.10

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Описание (английский):

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.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

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.

ISO 13619:2024 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications and users

Related standards

Технические детали

ISO 23723:2021

Traditional Chinese medicine — General requirements for herbal raw material and materia medica

ISO 18664:2015

Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in Traditional Chinese…

ISO 22258:2020

Traditional Chinese medicine — Determination of pesticide residues in natural products by gas chromatography

ISO/TS 21310:2020

Traditional Chinese medicine — Microscopic examination of medicinal herbs

ISO 2137:1972

Petroleum products — Lubricating grease — Determination of cone penetration

ISO 22217:2020

Traditional Chinese medicine —Storage requirements for raw materials and decoction pieces