Traditional Chinese medicine - Determination of sulfur dioxide in natural products by titration

This document specifies the determination method of sulfur dioxide in natural products used in traditional Chinese medicine, which includes the requirements of the device, chemicals, operational procedures and formula. It is applicable to natural products of traditional Chinese medicine, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from plants or animals. It is not applicable to minerals used in traditional Chinese medicine.

Médecine traditionnelle chinoise — Dosage du dioxyde de soufre dans les produits naturels par titrage

General Information

Status
Published
Publication Date
02-Nov-2020
Current Stage
9020 - International Standard under periodical review
Start Date
15-Oct-2025
Completion Date
15-Oct-2025
Ref Project

Relations

Overview

ISO 22590:2020 - Traditional Chinese medicine - Determination of sulfur dioxide in natural products by titration - defines a standardized titration-based method to quantify sulfur dioxide (SO2) residues in natural products used in traditional Chinese medicine (TCM). The standard covers required apparatus, reagents, sampling and preservation, the test procedure, and the calculation for reporting results (mg/kg). It applies to plant- and animal-derived Chinese materia medica and decoction pieces, but not to mineral materials.

Key topics and technical requirements

  • Scope and purpose: Measurement of sulfur dioxide residue in TCM natural products for quality control and safety assessment.
  • Apparatus: Typical lab glassware including a three‑neck round‑bottom flask, separatory funnel, condenser, test tube and an electronic balance (minimum 0.1 mg).
  • Reagents: Analytical grade/distilled water; indicators and chemicals such as bromophenol blue, hydrochloric acid, hydrogen peroxide (3 %), and 0.10 mol/L sodium hydroxide (standard titrant).
  • Sampling & sample prep: Requirements for sample labelling, drying, powdering and short‑term storage (cool, dry, avoid sunlight). Timely pre‑treatment and refrigerated storage when immediate analysis is not possible.
  • Test procedure (summary): CO2 purge of apparatus, addition of H2O2 and indicator, acidification of the sample to release SO2, boiling/distillation under CO2 stream, collection and acid‑base titration with NaOH, and blank titration.
  • Calculation: Reported as mg/kg. The standard provides the calculation formula: Sulfur dioxide (mg/kg) = 32 030 × (V1 − V2) × (n / m) where V1 = titrant volume (test), V2 = titrant volume (blank), n = molarity of NaOH, m = sample mass (g).
  • Informative annexes: Annex A lists national/regional limits and risk‑based calculations (WHO/USEPA references); Annex B describes a validated gas‑chromatography alternative; Annex C compares acid‑base titration practices internationally.

Applications

  • Routine quality control testing of Chinese materia medica and decoction pieces to detect sulfur dioxide residues.
  • Regulatory compliance monitoring against national MRLs and WHO/FAO guidance.
  • Safety and exposure assessment using ADI and target hazard quotient approaches cited in Annex A.
  • Method validation and comparison with gas chromatography for laboratories seeking higher sensitivity or confirmatory analysis.

Who should use this standard

  • TCM manufacturers and raw material suppliers
  • Independent analytical and pharmaceutical testing laboratories
  • Regulatory agencies and public health bodies overseeing herbal product safety
  • Quality assurance/quality control (QA/QC) teams and researchers working on herbal pharmacopoeia standards

Related standards and references

  • Annex B (ISO 22590) - gas chromatography method for SO2 (informative alternative)
  • Annex C (ISO 22590) - international comparison of acid‑base titration practices
  • ISO/TC 249 (Traditional Chinese medicine) developed the document; national guidance (WHO, USEPA) and pharmacopoeial references are cited for risk assessment and MRL context.
Standard
ISO 22590:2020 - Traditional Chinese medicine — Determination of sulfur dioxide in natural products by titration Released:11/3/2020
English language
13 pages
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Standards Content (Sample)


INTERNATIONAL ISO
STANDARD 22590
First edition
2020-11
Traditional Chinese medicine —
Determination of sulfur dioxide in
natural products by titration
Médecine traditionnelle chinoise — Dosage du dioxyde de soufre dans
les produits naturels par titrage
Reference number
©
ISO 2020
© ISO 2020
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 the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address
below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved

Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Apparatus . 2
5 Reagents . 2
6 Sampling and preservation of samples . 2
6.1 Sampling . 2
6.1.1 Laboratory samples . 2
6.1.2 Sample identification . 2
6.2 Sample preparation and preservation . 3
6.2.1 Sample preparation . 3
6.2.2 Sample preservation . 3
7 Test method . 3
7.1 T est procedure . 3
7.2 Calculation . 4
Annex A (informative) Reference of national, regional and organizational limits of
sulfur dioxide in food and natural products of traditional Chinese medicine and
calculated limits using target hazard quotients based on USEPA and WHO .6
Annex B (informative) Gas chromatography — Determination of sulfur dioxide in natural
traditional Chinese medicine materials . 9
Annex C (informative) Analysis of the similarities and differences of acid-base titration
in different countries .10
Bibliography .13
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.
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 2020 – All rights reserved

INTERNATIONAL STANDARD ISO 22590:2020(E)
Traditional Chinese medicine — Determination of sulfur
dioxide in natural products by titration
1 Scope
This document specifies the determination method of sulfur dioxide in natural products used in
traditional Chinese medicine, which includes the requirements of the device, chemicals, operational
procedures and formula.
It is applicable to natural products of traditional Chinese medicine, including Chinese materia medica
(whole medicinal materials) and decoction pieces derived from plants or animals.
It is not applicable to 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 terminological databases for use in standardization at the following addresses:
— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
sulfur dioxide
toxic gas with a pungent, irritating odour, the chemical compound with the formula SO
3.2
sulfur dioxide residue
sulfur dioxide that remains in or on a natural product
Note 1 to entry: Sulfur dioxide residue is expressed as mg/kg.
3.3
maximum residue limit
MRL
highest level of sulfur dioxide that is permitted in or on a natural product
Note 1 to entry: Maximum residue limit is expressed as mg/kg.
3.4
acceptable daily intake
ADI
estimate of the amount of sulfur dioxide in natural products that can be safely consumed daily over a
lifetime without adverse health effects
Note 1 to entry: ADI is expressed in milligrams of the sulfur dioxide, as it appears in the natural products, per
kilograms of body mass per day (mg/kg/day).
3.5
acid-base titration
determination of the concentration of an acid or base by exactly neutralizing the acid or base with a
base or acid of known concentration
4 Apparatus
4.1 Glass sample, cleaned thoroughly before use.
4.2 Electronic balance, with a minimum reading of 0,1 mg.
4.3 Separatory funnel, with a capacity of 50 ml or 100 ml.
4.4 Round-bottom flask, with a capacity of 500 ml or 1 000 ml.
5 Reagents
All reagents shall be of recognized chromatographic grade or analytical purity. Distilled water or water
of equivalent purity or above, recently boiled, shall be used.
5.1 Distilled water.
5.2 Bromophenol blue, 1 g/l solution of bromophenol blue in ethanol (20 % volume fraction).
5.3 Hydrochloric acid, 6 mol/l solution of diluted hydrochloric acid. Dilute one volume of concentrated
hydrochloric acid.
5.4 Hydrogen peroxide, 3 % volume fraction solution of diluted hydrogen peroxide, free from
sulfate ions.
5.5 Sodium hydroxide, 0,1 mol/l solution of sodium hydroxide (standard volumetric solution).
6 Sampling and preservation of samples
6.1 Sampling
6.1.1 Laboratory samples
Raw material samples received by the laboratory shall be accompanied with complete information such
as the source and time of collection of the samples. The samples for testing can include Chinese materia
medica (whole medicinal materials) and decoction pieces derived from plants or animals.
6.1.2 Sample identification
When a sample is received, it shall be immediately assigned a unique label which will accompany it
through all stages of the analysis to the reporting of the results. Samples shall be subject to the
appropriate disposal review system and all records shall be accurately kept.
2 © ISO 2020 – All rights reserved

6.2 Sample preparation and preservation
6.2.1 Sample preparation
Before testing, the sample shall be dried and powdered. Samples shall be pre-treated as soon as possible
and stored in a cool and dry place – if possible, in a refrigerator.
6.2.2 Sample preservation
If samples cannot be analysed immediately, they shall be stored in a cool and dry place, away from the
direct sunlight, and analysed within a few days.
7 Test method
7.1 Test procedure
a) Introduce 150 ml of water into the flask (see Figure 1, key 1), open the condenser pipe (key 3) and
pass carbon dioxide through the whole system for 15 min at a rate of 100 ± 5 ml/min. To 10 ml of
diluted hydrogen peroxide solution add 0,15 ml of a 1 g/l solution of bromophenol blue in ethanol
(20 % volume fraction).
b) Add 0,1 M sodium hydroxide until a violet-blue colour is obtained, without exceeding the end point.
c) Place the solution in the test tube (key 4). Without interrupting the stream of carbon dioxide,
remove the funnel (key 2) and introduce through the opening into the flask 25,0 g of the prepared
sample, with the aid of 100 ml of water.
d) Replace the funnel.
e) Close the tap of the funnel
...

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Frequently Asked Questions

ISO 22590:2020 is a standard published by the International Organization for Standardization (ISO). Its full title is "Traditional Chinese medicine - Determination of sulfur dioxide in natural products by titration". This standard covers: This document specifies the determination method of sulfur dioxide in natural products used in traditional Chinese medicine, which includes the requirements of the device, chemicals, operational procedures and formula. It is applicable to natural products of traditional Chinese medicine, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from plants or animals. It is not applicable to minerals used in traditional Chinese medicine.

This document specifies the determination method of sulfur dioxide in natural products used in traditional Chinese medicine, which includes the requirements of the device, chemicals, operational procedures and formula. It is applicable to natural products of traditional Chinese medicine, including Chinese materia medica (whole medicinal materials) and decoction pieces derived from plants or animals. It is not applicable to minerals used in traditional Chinese medicine.

ISO 22590:2020 is classified under the following ICS (International Classification for Standards) categories: 11.120.10 - Medicaments. The ICS classification helps identify the subject area and facilitates finding related standards.

ISO 22590:2020 has the following relationships with other standards: It is inter standard links to ISO 21606:2022. Understanding these relationships helps ensure you are using the most current and applicable version of the standard.

You can purchase ISO 22590:2020 directly from iTeh Standards. The document is available in PDF format and is delivered instantly after payment. Add the standard to your cart and complete the secure checkout process. iTeh Standards is an authorized distributor of ISO standards.

기사 제목: ISO 22590:2020 - 중국 전통 의약품에서 황산화 아황산물 결정 방법 기사 내용: 이 문서는 중국 전통 의약품에 사용되는 천연 제품에서 황산화 아황산물을 결정하는 방법을 명시한다. 이는 기기, 화학물질, 작업 절차 및 공식의 요구 사항을 포함한다. 이 방법은 중국 전통 의약품인 한약재(약재의 전체)와 식물 또는 동물로부터 유래된 토액 조각 등의 천연 제품에 적용된다. 그러나 중국 전통 의약품에 사용되는 광물에는 적용되지 않는다.

ISO 22590:2020 is a standard that outlines the method for determining the amount of sulfur dioxide in natural products used in traditional Chinese medicine. The document includes requirements for equipment, chemicals, procedures, and formulas. This method applies to natural products of traditional Chinese medicine, such as medicinal materials and plant or animal-based decoction pieces. However, it does not apply to minerals used in traditional Chinese medicine.

記事のタイトル:ISO 22590:2020 - 伝統的中国医学における天然製品中の二酸化硫黄の定量方法 記事内容:このドキュメントは、伝統的中国医学で使用される天然製品における二酸化硫黄の定量方法を規定しています。装置、化学薬品、操作手順、および計算式に関する要件が含まれています。この方法は、漢方薬(薬材全体)や植物または動物由来の煎じ薬など、伝統的中国医学の天然製品に適用されます。ただし、伝統的中国医学で使用される鉱物には適用されません。