ISO 21314:2019

Traditional Chinese medicine — Salvia miltiorrhiza root and rhizome

This document specifies the minimum requirements and test methods for Salvia miltiorrhiza root and rhizome, which is derived from the Salvia miltiorrhiza Bge. plant. It is applicable to Salvia miltiorrhiza root and rhizome that is sold and used as a natural medicine in international trade, including unprocessed and traditionally processed materials.

Médecine traditionnelle chinoise — Racine et rhizome de Salvia miltiorrhiza

General Information

• Status: Published
• Publication Date: 18-Feb-2019
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 1 - Quality and safety of raw materials and traditional processing
• Current Stage: 9020 - International Standard under periodical review
• Start Date: 15-Jan-2024
• Completion Date: 15-Jan-2024

Relations

• Consolidated By: ISO 6717:2021 - In vitro diagnostic medical devices — Single-use containers for the collection of specimens from humans other than blood
• Effective Date: 06-Jun-2022

Standards Content (Sample)

INTERNATIONAL ISO
STANDARD 21314
First edition
2019-02
Traditional Chinese medicine — Salvia
miltiorrhiza root and rhizome
Médecine traditionnelle chinoise — Racine et rhizome de Salvia
miltiorrhiza
Reference number
ISO 21314:2019(E)
©
ISO 2019

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ISO 21314:2019(E)

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ii © ISO 2019 – All rights reserved

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ISO 21314:2019(E)

Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Descriptions . 2
5 Requirements . 2
5.1 General characteristics . 2
5.2 Salvia miltiorrhiza root and rhizome . 3
5.2.1 Morphological features of root and rhizome . 3
5.2.2 Thin-layer chromatogram (TLC) identification . . 3
5.2.3 Moisture . 3
5.2.4 Total ash . 3
5.2.5 Acid insoluble ash limit . 3
5.2.6 Extractives . 3
5.2.7 Content of tanshinones. 3
5.2.8 Content of salvianolic acid B . 3
5.2.9 Heavy metals . 4
5.2.10 Pesticide residues . 4
6 Sampling .
...