ISO/FDIS 23956

Traditional Chinese medicine -- Determination of benzopyrene in processed natural products

Médecine traditionnelle chinoise -- Dosage du benzopyrène dans les produits naturels transformés

General Information

• Status: Published
• ICS: 11.120.10 - Medicaments
• Technical Committee: ISO/TC 249 - Traditional Chinese medicine
• Drafting Committee: ISO/TC 249/WG 2 - Quality and safety of manufactured TCM products
• Current Stage: 5060 - Close of voting Proof returned by Secretariat
• Completion Date: 22-Dec-2021

Standards Content (sample)

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 23956
ISO/TC 249
Traditional Chinese medicine —
Secretariat: SAC
Determination of benzopyrene in
Voting begins on:
2021-10-27 processed natural products
Voting terminates on:
2021-12-22
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 23956:2021(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 23956:2021(E)
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© ISO 2021

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

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ISO/FDIS 23956:2021(E)
Contents Page

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

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

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

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

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

4 Test methods ............................................................................................................................................................................................................ 2

4.1 Reagents and apparatus ................................................................................................................................................................. 2

4.1.1 Reagents ..................................................................................................................................................................................... 2

4.1.2 Apparatus ................................................................................................................................................................................. 2

4.2 Sample preparation ............................................................................................................................................................................ 2

4.3 HPLC-FLD method ............................................................................................................................................................................... 3

4.3.1 Chromatographic condition ..................................................................................................................................... 3

4.3.2 Identification ......................................................................................................................................................................... 3

4.3.3 Construction of calibration curve ....................................................................................................................... 3

4.3.4 Quantification ....................................................................................................................................................................... 3

4.4 GC-MS method ......................................................................................................................................................................................... 4

4.4.1 Chromatographic conditions ................................................................................................................................... 4

4.4.2 Assay ............................................................................................................................................................................................. 4

Annex A (informative) Chemical information of benzopyrene ............................................................................................... 6

Annex B (informative) National regulations and limitations of benzopyrene .......................................................7

Annex C (informative) The example of HPLC pattern about benzopyrene(s) ..........................................................8

Annex D (informative) Determination of benzopyrene(s) in wood creosote ...........................................................9

Bibliography .............................................................................................................................................................................................................................10

iii
© ISO 2021 – All rights reserved
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ISO/FDIS 23956:2021(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

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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).

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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.
© ISO 2021 – All rights reserved
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ISO/FDIS 23956:2021(E)
Introduction

The International Agency for Research on Cancer (IARC) classified benzopyrene (C H ) as a carcinogen

20 12
[1]

(Group 1) in 2006. Benzopyrene is produced by the incomplete combustion of carbohydrates, proteins

and fats during high-temperature cooking and processing of raw materials. To prevent hazards induced

by benzopyrene, it is important to determine the benzopyrene content in processed natural products

used in traditional Chinese medicine (e.g. processed Rehmannia root, Cyperus rhizome and mume fruit),

which are processed by the application of high temperatures (200 °C to 600 °C).

Some national pharmacopeias have technical guidelines for the determination of benzopyrene

[2,3]

content . This document describes an analytical method, including the device specifications,

chemical reagents, operation procedures and formulae to determine benzopyrene content, considering

each national pharmacopeia, as well as giving references to other standardized testing methods,

maximum limits and risk assessment.
© ISO 2021 – All rights reserved
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 23956:2021(E)
Traditional Chinese medicine — Determination of
benzopyrene in processed natural products
1 Scope

This document specifies the method for the determination of benzopyrene content in processed natural

products.

It is applicable to processed natural products such as processed Rehmannia root, processed Cyperus

rhizome, processed ginseng and processed mume fruit. It is not applicable to the analysis of minerals

used in traditional Chinese medicine.
2 Normative references
There are no normative references in this document.
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
benzopyrene
C H
20 12
organic compound of pentacyclic hydrocarbons made of pyrene and phenylene group

Note 1 to entry: The chemical information of benzopyrene is described in Annex A. National regulations and

limitations of benzopyrene are given in Annex B.
3.2
polycyclic aromatic hydrocarbon
PAH

compound that contains two or more fused aromatic rings made of only carbon and hydrogen atoms

[SOURCE: ISO 11338-1:2003, 3.3]
3.3
high-performance liquid chromatography
HPLC

technique in analytical chemistry used to separate, identify and quantify each component in a mixture

Note 1 to entry: High-performance liquid chromatography relies on pumps to pass a pressurized liquid solvent

containing the sample mixture through a column filled with a solid adsorbent material. Each component

in the sample interacts differently with the adsorbent material, resulting in different flow rates for different

components, thereby leading to the separation of components as these flow out of the column.

© ISO 2021 – All rights reserved
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ISO/FDIS 23956:2021(E)
3.4
gas chromatography

analytical technique used to separate and determine the components of complex mixtures based on

partitioning between gas and stationary p
...