ISO/FDIS 23972

Traditional Chinese medicine -- Zingiber officinale rhizome

Titre manque

General Information

• Status: Published
• 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: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 22-Jul-2021
• Completion Date: 22-Jul-2021

Standards Content (sample)

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 23972
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Zingiber officinale rhizome
Voting begins on:
2021­07­22
Voting terminates on:
2021­09­16
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO­
ISO/FDIS 23972:2021(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN­
DARDS TO WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS. ISO 2021
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ISO/FDIS 23972:2021(E)
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© ISO 2021

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ii © ISO 2021 – All rights reserved
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ISO/FDIS 23972:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction ..................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3 Terms and definitions ..................................................................................................................................................................................... 1

4 Descriptions .............................................................................................................................................................................................................. 2

5 Requirements .......................................................................................................................................................................................................... 3

5.1 General characteristics ..................................................................................................................................................................... 3

5.2 Zingiber officinale rhizome ....................................................................................................................................................... 3

5.2.1 Morphological features of rhizome .................................................................................................................. 3

5.2.2 Microscopic characteristics .................................................................................................................................... 3

5.2.3 Thin-layer chromatogram (TLC) identification .................. ................................................................... 3

5.2.4 Moisture content .............................................................................................................................................................. 3

5.2.5 Total ash .................................................................................................................................................................................. 3

5.2.6 Volatile oil .............................................................................................................................................................................. 4

5.2.7 Marker compound .......................................................................................................................................................... 4

5.2.8 Water-soluble extractives ........................................................................................................................................ 4

5.2.9 Heavy metals ....................................................................................................................................................................... 4

5.2.10 Pesticide residues ........................................................................................................................................................... 4

5.2.11 Residue of sulfur dioxide .......................................................................................................................................... 4

6 Sampling ........................................................................................................................................................................................................................ 4

7 Test methods ............................................................................................................................................................................................................. 4

7.1 Macroscopic identification ........................................................................................................................................................... 4

7.2 Microscopic identification ............................................................................................................................................................. 5

7.3 Thin-layer chromatogram (TLC) identification .......................................................................................................... 5

7.4 Determination of moisture content ...................................................................................................................................... 5

7.5 Determination of total ash content........................................................................................................................................ 5

7.6 Determination of volatile oil ....................................................................................................................................................... 5

7.7 Determination of marker compound 6­gingerol ....................................................................................................... 5

7.8 Determination of water-soluble extractives .................................................................................................................. 5

7.9 Determination of heavy metals ................................................................................................................................................. 5

7.10 Determination of pesticide residues .................................................................................................................................... 5

7.11 Determination of residue of sulfur dioxide .................................................................................................................... 5

8 Test report ................................................................................................................................................................................................................... 5

9 Packaging and storage .................................................................................................................................................................................... 6

10 Marking and labelling ..................................................................................................................................................................................... 6

Annex A (informative) Thin-layer chromatogram (TLC) identification ........................................................................... 7

Annex B (informative) Determination of moisture content ......................................................................................................... 9

Annex C (informative) Determination of 6-gingerol .........................................................................................................................11

Annex D (informative) Determination of water-soluble extractives ................................................................................13

Annex E (informative) Referenced values of moisture, total ash, gingerol, volatile oil and

water-soluble extractives contents on Zingiber officinale rhizome in different

national and regional standards .......................................................................................................................................................14

Bibliography .............................................................................................................................................................................................................................15

© ISO 2021 – All rights reserved iii
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ISO/FDIS 23972:2021(E)
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 has been established has the right to be represented on that committee. International

organizations, governmental and non­governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

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 documents 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).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.

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 © ISO 2021 – All rights reserved
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ISO/FDIS 23972:2021(E)
Introduction

Zingiber officinale rhizome is one of the most commonly used traditional Chinese medicines in the

world. At present the global scope of Zingiber officinale rhizome covers medicinal products in addition to

raw materials, including powder, ginger tea, extract, capsule, tincture and other dosage forms. Quality

standards are given in the pharmacopoeia of various countries, including the Chinese pharmacopoeia,

the European pharmacopoeia, the United States Pharmacopoeia, the Japanese Pharmacopoeia, the

Korean Pharmacopoeia and the British Pharmacopoeia. However, there are some differences between

these pharmacopoeia, such as trait description, identification methods, inspection indicators and limits,

methods and indicators of content determination and storage. ISO published the relevant standards

of Zingiber officinale rhizome as a spice in 2018, such as ISO 1003, but these lacked an investigation

of the medicinal components of Zingiber officinale rhizome. The identification and quality control of

medicinal materials are also different in the various pharmacopoeia, which are therefore not suitable

for the quality control of medicinal Zingiber officinale rhizome. In the international context of gradually

improving the quality requirements of traditional Chinese medicine, it is particularly important to

establish International Standards for Zingiber officinale rhizome in order to promote the international

circulation of medicinal Zingiber officinale rhizome products.

Zingiber officinale rhizome is also widely used throughout the world as a food supplement and spice,

which indicates a good safety profile. As national implementation can differ, national standards bodies

are invited to modify the values given in 5.2.4, 5.2.5, 5.2.6, 5.2.7 and 5.2.8 in their national standards.

Examples of national and regional values are given in Annex E, Table E.1.
© ISO 2021 – All rights reserved v
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 23972:2021(E)
Traditional Chinese medicine — Zingiber officinale
rhizome
1 Scope

This document specifies the quality and safety requirements of Zingiber officinale rhizome derived from

the plant Zingiber officinale Roscoe, including the minimum requirements and test methods.

This document applies to Zingiber officinale rhizome that is sold and used as natural medicines in

international trade, including Chinese material medica (whole medicinal materials) and decoction

pieces derived from this plant. It is not applicable to Zingiber officinale rhizome sold and used as food or

spices.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 1003, Spices — Ginger (Zingiber officinale Roscoe) — Specification

ISO 6571, Spices, condiments and herbs — Determination of volatile oil content (hydrodistillation method)

ISO 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in

Traditional Chinese Medicine

ISO/TS 21310, Traditional Chinese medicine — Microscopic examination on medicinal herbs

ISO 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topical

use

ISO 22258, Traditional Chinese medicine — Determination of pesticide residues in natural products by gas

chromatography
ISO 22590, Traditional
...