Traditional Chinese Medicine — General requirements for the ultrafine powder of herbs

This document specifies general requirements for ultrafine powder of herbs to ensure their quality and safety. This document applies to ultrafine powder of herbs that are sold and used as natural medicines in international trade, including finished products derived from this powder.

Médecine traditionnelle chinoise — Exigences générales relatives à la poudre ultrafine d'herbes médicinales

General Information

Status
Published
Publication Date
21-Apr-2024
Current Stage
6060 - International Standard published
Start Date
22-Apr-2024
Due Date
10-May-2024
Completion Date
22-Apr-2024
Ref Project
Standard
ISO 6904:2024 - Traditional Chinese Medicine — General requirements for the ultrafine powder of herbs Released:22. 04. 2024
English language
6 pages
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Standards Content (Sample)


International
Standard
ISO 6904
First edition
Traditional Chinese Medicine —
2024-04
General requirements for the
ultrafine powder of herbs
Médecine traditionnelle chinoise — Exigences générales relatives
à la poudre ultrafine d'herbes médicinales
Reference number
© ISO 2024
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Published in Switzerland
ii
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
4.1 General .2
4.2 Identification .2
4.3 Assay .2
4.4 Determination of extractives .3
4.5 Determination of moisture content .3
4.6 Uniformity of appearance .3
4.7 Particle size distribution .3
4.8 Pesticide residues .3
4.9 Heavy metals .3
4.10 Residue of sulfur dioxide .3
4.11 Mycotoxins .3
4.12 Microorganisms .3
4.13 Aristolochic acids .4
4.14 Aconitum alkaloids .4
5 Test methods . 4
5.1 Identification .4
5.2 Assay .4
5.3 Extractives .4
5.4 Moisture .4
5.5 Uniformity of appearance .4
5.6 Particle size distribution .4
5.7 Pesticide residues .4
5.8 Heavy metals .4
5.9 Residue of sulfur dioxide .4
5.10 Mycotoxins .4
5.11 Microorganism .5
5.12 Aristolochic acids .5
5.13 Aconitum alkaloids .5
6 Packaging and labelling . 5
Bibliography . 6

iii
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national standards
bodies (ISO member bodies). The work of preparing International Standards is normally carried out through
ISO technical committees. Each member body interested in a subject for which a technical committee
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The procedures used to develop this document and those intended for its further maintenance are described
in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the different types
of ISO document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
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This document was prepared by Technical Committee ISO/TC 249, Traditional Chinese medicine.
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.

iv
Introduction
Ultrafine powder of herbs is an innovative development of the traditional powder form of decoction pieces
that have been used commonly in traditional Chinese medicine for over 2 000 years. Ultrafine powder of
herbs is prepared by pulverizing decoction pieces into ultrafine powder, followed by systematic quality
analyses, which can increase the utilization efficiency, ensure consistency of quality and guarantee the
safety of Chinese medicines. Ultrafine powder of herbs can be directly taken orally but is more commonly
used as a raw material in the preparation of finished products. This is done by turning ultrafine powder of
herbs into dosage form, such as granules, capsules or tablets, in order to achieve longer storage times and
make its use more convenient.
Ultrafine powder of herbs and its products are becoming increasingly popular due to the obvious advantages
in safety control
...

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