Traditional Chinese medicine — Quality and safety of raw materials and finished products made with raw materials — Part 3: Testing for contaminants

This document specifies the sample preparation methods for the determination of contamination of natural products by heavy metals, pesticides, aflatoxins and microorganisms. It is applicable to raw materials and finished products used in traditional Chinese medicine.

Médecine traditionnelle chinoise — Qualité et sécurité des matières premières et des produits finis fabriqués à partir de matières premières — Partie 3: Essais pour la recherche de contaminants

General Information

Status
Published
Publication Date
14-Nov-2022
Current Stage
6060 - International Standard published
Due Date
16-Jul-2022
Completion Date
15-Nov-2022
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INTERNATIONAL ISO
STANDARD 19609-3
First edition
2022-11
Traditional Chinese medicine —
Quality and safety of raw materials
and finished products made with raw
materials —
Part 3:
Testing for contaminants
Médecine traditionnelle chinoise — Qualité et sécurité des matières
premières et des produits finis fabriqués à partir de matières
premières —
Partie 3: Essais pour la recherche de contaminants
Reference number
ISO 19609-3:2022(E)
© ISO 2022
---------------------- Page: 1 ----------------------
ISO 19609-3:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on

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or ISO’s member body in the country of the requester.
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Website: www.iso.org
Published in Switzerland
© ISO 2022 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 19609-3:2022(E)
Contents Page

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

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

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

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

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

4 Testing of contaminants .............................................................................................................................................................................. 2

4.1 Determination of heavy metals in herbal medicines and products used in and as

traditional Chinese medicine ........................................................................................................................................... .......... 2

4.1.1 General ........................................................................................................................................................................................ 2

4.1.2 Sample preparation ......................................................................................................................................................... 2

4.1.3 Liberation or release of heavy metals with microwave digestion ......................................... 3

4.1.4 Sample solution ................................................................................................................................................................... 4

4.1.5 Measurement of heavy metals ............................................................................................................................... 4

4.1.6 Method validity and reporting .............................................................................................................................. 5

4.2 Determination of pesticides in herbal medicines and products used in and as

traditional Chinese medicine ........................................................................................................................................... .......... 5

4.2.1 General ........................................................................................................................................................................................ 5

4.2.2 Sample preparation ......................................................................................................................................................... 5

4.2.3 Extraction of pesticides ............................................................................................................................................... 5

4.2.4 Extraction method ............................................................................................................................................................ 6

4.2.5 Sample solution ................................................................................................................................................................... 6

4.2.6 Measurement of pesticides........................................................................................................................................ 6

4.2.7 Method validity and reporting .............................................................................................................................. 6

4.3 Determination of aflatoxins in herbal medicines and products used in and as

traditional Chinese medicine ........................................................................................................................................... .......... 6

4.3.1 General ........................................................................................................................................................................................ 6

4 . 3 . 2 S a mple pr ep a r at ion ......................................................................................................................................................... 7

4.3.3 Extraction of aflatoxins ........................................................................................................................................... ..... 7

4.3.4 Sample solution ................................................................................................................................................................... 8

4.3.5 Measurement of aflatoxins ........................................................................................................................................ 8

4.3.6 Method validity and reporting .............................................................................................................................. 8

4.4 Determination of microbial contamination in herbal medicines and products used

in and as traditional Chinese medicine ............................................................................................................................ 8

4.4.1 General ........................................................................................................................................................................................ 8

4.4.2 Sample preparation ......................................................................................................................................................... 8

4.4.3 Sample solution ................................................................................................................................................................... 9

4.4.4 Reagents and buffer solution ................................................................................................................................... 9

4.4.5 Measurement of the content of microorganisms ................................................................................ 10

4.4.6 Method validity and reporting ........................................................................................................................... 10

Bibliography .............................................................................................................................................................................................................................11

iii
© ISO 2022 – All rights reserved
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ISO 19609-3:2022(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 non-governmental, 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.

A list of all parts in the ISO 19609 series can be found on the ISO website.

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.
© ISO 2022 – All rights reserved
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ISO 19609-3:2022(E)
Introduction

The ISO 19609 series consists of four parts with different content, as shown in Figure 1.

Figure 1 — Overview of the ISO 19609 series

To ensure the safety of herbal medicinal products, all raw materials and products must be analysed

for possible contamination. In this field four main types of contaminants are controlled so that their

absence or presence is lower than the relevant limit values defined by different target markets or

nations.

Specific documents for heavy metals, pesticides, aflatoxins and microorganisms have been developed

within the framework of ISO/TC 249.
© ISO 2022 – All rights reserved
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INTERNATIONAL STANDARD ISO 19609-3:2022(E)
Traditional Chinese medicine — Quality and safety of
raw materials and finished products made with raw
materials —
Part 3:
Testing for contaminants
1 Scope

This document specifies the sample preparation methods for the determination of contamination of

natural products by heavy metals, pesticides, aflatoxins and microorganisms. It is applicable to raw

materials and finished products used in traditional Chinese medicine.
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 18664, Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in

Traditional Chinese Medicine

ISO 19609-1:2021, Traditional Chinese medicine — Quality and safety of raw materials and finished

products made with raw materials — Part 1: General requirements

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

chromatography

ISO 22283, Traditional Chinese medicine — Determination of aflatoxins in natural products by LC-FLD

ISO 22467, Traditional Chinese medicine — Determination of microorganisms in natural products

3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminology databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at https:// www .electropedia .org/
3.1
aflatoxin

naturally occurring poisonous, carcinogenic and mutagenic mycotoxin, produced by certain fungi

(mainly Aspergillus species), commonly found on agricultural crops
3.2
compactate

irregular-shaped agglomerate obtained directly from the dried extract-by-compaction

[SOURCE: ISO 23419: 2021, 3.4, modified — Note to entry removed.]
© ISO 2022 – All rights reserved
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ISO 19609-3:2022(E)
3.3
heavy metal

metal with relatively high density as a natural constituent of the environment, commonly detected in

air, water and soil
3.4
microbial contamination
presence of unintended bacteria, fungi, protozoa or viruses
Note 1 to entry: This can include extrinsic and/or intrinsic contamination.
[SOURCE: ISO 18362:2016, 3.17]
3.5
microorganism
entity of microscopic size, encompassing bacteria, fungi, protozoa and viruses
[SOURCE: ISO 11139:2018, 3.176]
3.6
pesticide

substance or mixture of substances intended to prevent, destroy, repel or mitigate any pest or weed

Note 1 to entry: Pesticides (plant protection products) approved for use in one country will not necessarily be

approved in another country.
[SOURCE: ISO 18889:2019, 3.7, modified — Note to entry revised.]
4 Testing of contaminants

4.1 Determination of heavy metals in herbal medicines and products used in and as

traditional Chinese medicine
4.1.1 General
The determination of heavy metals shall be done in accordance with ISO 18664.
4.1.2 Sample preparation
4.1.2.1 General

The quality and reliability of analytical results depend on both the analytical method and the sample

preparation of the test sample. If a sample preparation is not appropriate, the analytical results can

be slightly incorrect or completely wrong. Sample preparation methods depend on the constitution

of the testing material. Typical established sample preparation techniques are listed in the following

subclauses.
4.1.2.2 Sample size for the determination of heavy metals
Based on experiences with pharmaceuticals worldwide, and especially herbal-based

phytopharmaceuticals, a typical amount of testing material is required. An appropriate sample size

should be 250 mg of dry or dried material or equivalent.
4.1.2.3 Solid samples

The preparation of test samples shall be carried out in accordance with ISO 19609-1:2021, 6.2.

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ISO 19609-3:2022(E)

The typical size of test material should be under 1 mm in diameter. Different starting test materials can

include the following:
a) crude materials (sliced or uncut, fresh or dried);
b) tablets, pills, dragees, capsules;
c) granules, compactates and powders;
d) other solid samples.

Crude materials, tablets, dragees and capsules shall be ground and sieved in accordance with

ISO 19609-1.

Granules, compactates and powders, as well as other solid samples, shall be ground only if necessary

and sieved in accordance with ISO 19609-1.
4.1.2.4 Semi-solid samples

Semi-solids are often emulsions of fatty constituents with waterish extracts or gelatinous gels based on

polysugars such as alginates.

Creams, ointments, lotions and other semi-solid samples shall be homogenized in an appropriate way.

The dry mass as a percentage of sample material shall be estimated.
4.1.2.5 Liquid samples

Extracts, tinctures, juices and other liquid samples shall be homogenized in an appropriate way.

The dry mass as a percentage of sample material shall be estimated.
4.1.3 Liberation or release of heavy metals with microwave digestion
4.1.3.1 General

A typical internationally recognized method for the release of heavy metals is microwave digestion.

4.1.3.2 Reagents
4.1.3.2.1 Distilled water (for trace analysis).
4.1.3.2.2 HNO (conc.) (for trace analysis).
4.1.3.2.3 H O (30 %) (for trace analysis).
2 2
4.1.3.3 Preparation method (microwave digestion) and materials
High-pressure PTFE vessels (microwave s
...

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