ISO 22212:2025 PDF

Name: ISO 22212:2025 — Traditional Chinese medicine — Gastrodia elata tuber
SKU: ISO 22212:2025
Price: 25 EUR
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Traditional Chinese medicine — Gastrodia elata tuber

Название (английский):

ISO 22212:2025

Traditional Chinese medicine — Gastrodia elata tuber

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 17
Дата публикации:: 18 декабря 2025 г.
Издание:: ISO IS 22212 edition 2 version 1
ICS:: 11.120.10

Тип поставки:

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Язык документа:

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Срок поставки:3 раб. дн. (перевод)

Цена:255 €

Описание (английский):

This document specifies minimum requirements and test methods for Gastrodia elata tuber that is derived from cultivated and artificially propagated Gastrodia elata Bl. It is applicable to Gastrodia elata tuber that is sold and used as Chinese materia medica, specifically excluding the wild forms of the species.

Abstract

Overview - ISO 22212:2025 for Gastrodia elata tuber

Key topics and technical requirements

The standard specifies descriptive, compositional and analytical requirements, including:

Morphology and physical characteristics: tuber size, shape, colour, texture and typical anatomical features (buds, latent buds, longitudinal wrinkles).
Quality limits:
- Moisture: mass fraction ≤ 16.0%
- Total ash: mass fraction ≤ 6.0%
- Dilute ethanol‑soluble extract: mass fraction ≥ 14.0%
- Marker compounds: sum of gastrodin and p‑hydroxybenzyl alcohol ≥ 0.20%
Identification: marker compounds (gastrodin, p‑hydroxybenzyl alcohol) identified by thin‑layer chromatography (TLC) showing specific spots/bands.
Contaminants and residues:
- Determination of heavy metals (arsenic, mercury, lead, cadmium)
- Determination of pesticide residues (including Benzex, dichlorodiphenyltrichloroethane (DDT) and quintozene)
- Sulfur dioxide content
Sampling and test methods:
- Sampling follows ISO 23723 (sample batch definitions, max batch size noted)
- Macroscopic identification requires random samples (≥ 500 g) for visual, smell and taste inspection
- Detailed test procedures and informative annexes (A–F) cover moisture, ethanol‑soluble extract, TLC identification and quantification of markers.

Practical applications and users

ISO 22212:2025 is intended for:

Manufacturers and cultivators of Gastrodia elata tuber for quality control and product specification
Analytical and contract laboratories performing routine testing (moisture, ash, marker assays, contaminants)
Regulatory authorities, customs and standards bodies assessing safety and conformity for trade
Pharmacopoeia committees and Traditional Chinese Medicine (TCM) product developers seeking harmonized test methods and acceptance criteria
Traders, distributors and buyers who require verified quality for clinical use or manufacturing

Related standards

Normative references used for methods and limits include:

ISO 23723 - general requirements for herbal raw material and materia medica
ISO 18664 - heavy metals determination
ISO 22258 - pesticide residues by GC
ISO 22590 - sulfur dioxide determination
ISO 21371 - labelling requirements

ISO 22212:2025 supports consistent, safe and traceable use of Gastrodia elata tuber across international markets and laboratory workflows.

Технические детали

Технический комитет: ISO/TC 249 - Traditional Chinese medicine
SKU: ISO 22212:2025

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