ISO/TS 21758:2026
(Main)Traditional Chinese medicine — General requirements of stick-type package for viscous extracts
Traditional Chinese medicine — General requirements of stick-type package for viscous extracts
This document specifies the general requirements for the safety and quality of stick-type single-dose package for viscous extracts. This document does not apply to solid dosage forms.
Titre manque
General Information
- Status
- Published
- Publication Date
- 25-Jan-2026
- Technical Committee
- ISO/TC 249 - Traditional Chinese medicine
- Drafting Committee
- ISO/TC 249 - Traditional Chinese medicine
- Current Stage
- 6060 - International Standard published
- Start Date
- 26-Jan-2026
- Due Date
- 09-Nov-2026
- Completion Date
- 26-Jan-2026
Overview
ISO/TS 21758:2025 provides general requirements for the design, safety, and quality of stick-type single-dose packages used for viscous extracts in Traditional Chinese Medicine (TCM). This technical specification applies exclusively to viscous extracts-dosage forms with a semi-liquid to semi-solid consistency-and explicitly excludes solid dosage forms. Developed by ISO Technical Committee ISO/TC 249, this standard aims to ensure consistent quality and safety in packaging materials and presentation to facilitate product integrity, patient safety, and regulatory compliance.
Key Topics
Scope and Applicability:
Focuses on single-dose, flexible stick-type packages intended for viscous extracts of medicinal herbs and compound formulas. Solid dosage forms are excluded.Terminology:
Definitions include viscous extracts, stick-type packages, heavy metals, and testing terms such as foaming test.Material and Appearance:
Packages must be free from contamination and physical damage. Uniform shape and secure adhesion of film layers are required. Correct and clear labeling in line with ISO 21371 ensures traceability and user information.Safety Testing:
- Heavy Metals Combustion Test: Ensures metal contaminants like lead are within safe limits.
- Extractable Substances Test: Includes foaming tests to detect surfactants, pH comparison with blank solutions, potassium permanganate reducing substances assessment, and residue on evaporation measurement to evaluate chemical safety and compatibility of packaging materials.
Test Methods:
Detailed procedures for external appearance inspection, combustion testing, and extractable substances analysis guarantee standardized evaluation of packaging safety and quality.
Applications
ISO/TS 21758 is crucial for manufacturers and quality control laboratories involved in the production and packaging of Traditional Chinese Medicine viscous extracts. Proper implementation ensures:
- Product Safety: Minimizes risks related to contamination by heavy metals or harmful extractable substances from packaging materials.
- Regulatory Compliance: Aligns with international practices enhancing market acceptance and export potential.
- Quality Assurance: Maintains packaging integrity during transportation and storage, preserving the efficacy and stability of medicinal extracts.
- Consumer Confidence: Clear labeling and hygienic packaging uphold patient trust and proper dosage administration.
This standard supports pharmaceutical companies, packaging manufacturers, and healthcare regulators in maintaining high standards in TCM product packaging.
Related Standards
- ISO 21371 – Traditional Chinese Medicine - Labelling requirements of products intended for oral or topical use: Dictates labeling criteria ensuring users receive correct and safe product information.
- WHO TRS 902 Annex 9 – Guidelines on packaging for pharmaceutical products: Provides general packaging guidelines for pharmaceutical safety that complement the specific requirements in ISO/TS 21758.
- Korean Pharmacopoeia (12th edition) and Japanese Pharmacopoeia (18th edition): These pharmacopoeias offer national pharmaceutical packaging test methods referred to in ISO/TS 21758, underpinning harmonized international practices.
By adhering to ISO/TS 21758, stakeholders in Traditional Chinese Medicine can enhance the quality and safety of stick-type packaging for viscous extracts, advancing consistent product standards worldwide. This ensures that traditional remedies are delivered with modern safety and quality assurance, meeting both consumer expectations and regulatory requirements.
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Frequently Asked Questions
ISO/TS 21758:2026 is a technical specification published by the International Organization for Standardization (ISO). Its full title is "Traditional Chinese medicine — General requirements of stick-type package for viscous extracts". This standard covers: This document specifies the general requirements for the safety and quality of stick-type single-dose package for viscous extracts. This document does not apply to solid dosage forms.
This document specifies the general requirements for the safety and quality of stick-type single-dose package for viscous extracts. This document does not apply to solid dosage forms.
ISO/TS 21758:2026 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/TS 21758:2026 is available in PDF format for immediate download after purchase. The document can be added to your cart and obtained through the secure checkout process. Digital delivery ensures instant access to the complete standard document.
Standards Content (Sample)
Technical
Specification
ISO/TS 21758
First edition
Traditional Chinese medicine —
2026-01
General requirements of stick-type
package for viscous extracts
Reference number
© ISO 2026
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 2
4.1 External appearance .2
4.2 Heavy metals in combustion test .2
4.3 Extractable substances test .2
4.3.1 Foaming test .2
4.3.2 pH .2
4.3.3 Potassium permanganate reducing substances.2
4.3.4 Residue on evaporation .2
5 Test methods . 2
5.1 External appearance .2
[2][3]
5.2 Combustion test .2
[2][3]
5.3 Extractable substances test .3
5.3.1 Test solution and blank solution Preparation .3
5.3.2 Foaming test .4
5.3.3 pH test .4
5.3.4 Potassium permanganate reducing substances test .4
5.3.5 Test for residue on evaporation .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
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 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
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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 medicine, Subcommittee SC 1,
Traditional Chinese medicine.
A list of all parts in the ISO TS 21758 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.
iv
Technical Specification ISO/TS 21758:2026(en)
Traditional Chinese medicine — General requirements of
stick-type package for viscous extracts
1 Scope
This document specifies the general requirements for the safety and quality of stick-type single-dose
package for viscous extracts. This document does not apply to solid dosage forms.
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 21371, Traditional Chinese medicine — Labelling requirements of products intended for oral or topi
...




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