ISO 9319:2024 PDF

Name: ISO 9319:2024 — Traditional Chinese medicine — Poria cocos sclerotium
SKU: ISO 9319:2024
Price: 25 EUR
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Traditional Chinese medicine — Poria cocos sclerotium

Название (английский):

ISO 9319:2024

Traditional Chinese medicine — Poria cocos sclerotium

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 13
Дата публикации:: 9 февраля 2024 г.
Издание:: ISO IS 9319 edition 1 version 1
ICS:: 11.120.10

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Цена:195 €

Описание (английский):

This document specifies the quality, safety requirements and test methods for Poria cocos sclerotium that is derived from the fungus Poria cocos (Schw.) Wolf. It is applicable to Poria cocos sclerotium sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces.

Abstract

Overview - ISO 9319:2024 (Poria cocos sclerotium)

Key topics and technical requirements

The standard covers identification, quality limits and laboratory methods, including:

Descriptions and trade forms: whole poria, cubic poria, sliced poria and powdered poria with macroscopic and morphological characteristics.
Identification methods: macroscopic and microscopic examination (powder morphology, hyphae characteristics) and thin‑layer chromatography (TLC) matching with reference solutions.
Chemical reactions: specified chemical colour reaction (e.g., iodinated potassium iodide produces a deep red colour on sample).
Quantitative quality limits:
- Moisture: not more than 15.0% mass fraction.
- Total ash: not more than 2.0% mass fraction.
Extractives: determination of ethanol‑soluble and water‑soluble extractives to assess extractable constituents.
Marker compound: determination of marker compound(s) such as pachymic acid (method included).
Safety testing: limits and test methods for heavy metals, pesticide residues and sulfur dioxide.
Sampling, test reporting, packaging, storage and labelling: requirements to ensure integrity during trade and use.
Informative annexes include TLC identification, pachymic acid determination and examples of national/regional values.

Applications - who uses ISO 9319 and why

ISO 9319 is practical for stakeholders across the supply chain:

Manufacturers and processors of Poria cocos sclerotium - to standardize production, processing and product specifications.
Quality control and analytical laboratories - to adopt validated test methods (microscopy, TLC, moisture, ash, pachymic acid, heavy metals, pesticide and SO2 testing).
Exporters/importers and traders - to demonstrate compliance with an internationally recognized specification for raw material and decoction pieces.
Regulators and pharmacopoeia authors - to harmonize national requirements and reduce trade barriers.
Practitioners of Traditional Chinese Medicine - to ensure clinical safety and consistent therapeutic quality of materia medica.

Related standards

ISO 9319 references and aligns with other ISO TCM standards, including:

ISO 18664 (heavy metals determination)
ISO/TS 21310 (microscopic examination)
ISO 21371 (labelling requirements)
ISO 22217 (storage requirements)
ISO 22258 (pesticide residues by GC)
ISO 22590 (sulfur dioxide determination)
ISO 23723 (general requirements for herbal raw materials)

Adoption of ISO 9319 improves supply-chain transparency, lab comparability and regulatory acceptance for Poria cocos sclerotium in global markets.

Технические детали

Технический комитет: ISO/TC 249 - Traditional Chinese medicine
SKU: ISO 9319:2024

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ISO 9319:2024 PDF

Abstract

Overview - ISO 9319:2024 (Poria cocos sclerotium)

Похожие стандарты

Key topics and technical requirements

Applications - who uses ISO 9319 and why

Related standards

Технические детали

ISO 18664:2015

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

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

ISO 22258:2020

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

ISO 22590:2020

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