ISO 19842:2025 PDF

Name: ISO 19842:2025 — Traditional Chinese medicine — Dioscorea opposita rhizome
SKU: ISO 19842:2025
Price: 25 EUR
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Traditional Chinese medicine — Dioscorea opposita rhizome

Название (английский):

ISO 19842:2025

Traditional Chinese medicine — Dioscorea opposita rhizome

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 10
Дата публикации:: 9 мая 2025 г.
Издание:: ISO IS 19842 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 Dioscorea opposita rhizome (dried rhizome of Dioscorea opposita Thunb.). It is applicable to Dioscorea opposita rhizomes 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 19842:2025 - Traditional Chinese medicine - Dioscorea opposita rhizome establishes internationally harmonized quality and safety requirements and test methods for the dried rhizome of Dioscorea opposita Thunb. (also used as Chinese materia medica and decoction pieces). The standard applies to rhizomes sold and used as natural medicines in international trade and supports consistent product quality, safety and regulatory compliance across markets.

Key topics and technical requirements

General requirements: material must be clean, free from leaves, visible contaminants, mould or live insects before sampling.

Morphology & microscopy: macroscopic description (15–30 cm length; 1.5–6 cm diameter; yellowish-white surface, powdery white section) and microscopic features (starch granules 8–35 μm, vessels 12–48 μm, calcium oxalate needle bundles ≈240 μm).

Limits:

Moisture: mass fraction ≤ 16.0 %.
Total ash: mass fraction ≤ 6.0 %.
Water‑soluble extractives: to be determined (method specified).

Contaminants & residues:

Heavy metals: determination of arsenic, mercury, lead and cadmium.
Pesticide residues: determination per specified methods.
Sulfur dioxide: determination required.

Identity testing: Thin-layer chromatography (TLC) identification - extract must show spot/band matching reference solution in color and Rf. (Annex A provides TLC details.)

Sampling & test methods: sampling follows ISO 23723; macroscopic ID samples not less than 500 g; test methods reference several ISO standards for microscopy, heavy metals, pesticides, sulfur dioxide and other measures.

Packaging, storage & transport: requirements to protect material from light, moisture and contamination; storage and packaging reference ISO 22217 and ISO 23723.

Practical applications and who uses this standard

ISO 19842:2025 is intended for:

Manufacturers and processors of Dioscorea opposita rhizome and decoction pieces - for quality control and product specification.

Testing laboratories and QC analysts - for validated sampling and test procedures (TLC, moisture, ash, contaminants).

Regulatory authorities and customs - to assess imported/exported TCM raw materials against harmonized safety limits.

Suppliers, exporters/importers and purchasers - to ensure consistent international trade quality.

Pharmacopeial bodies and standards developers - to align national regulations with an international baseline.

ISO 19842:2025 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications and who uses this standard

Related standards

Технические детали

ISO 23723:2021

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

ISO 22217:2020

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

ISO/TS 21310:2020

Traditional Chinese medicine — Microscopic examination of medicinal herbs

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 22590:2020

Traditional Chinese medicine — Determination of sulfur dioxide in natural products by titration

ISO 2137:1972

Petroleum products — Lubricating grease — Determination of cone penetration