Overview
ISO/TS 21758:2026, Traditional Chinese medicine - General requirements of stick-type package for viscous extracts, sets forth internationally recognized guidelines for the safety and quality of stick-type single-dose packaging designed for viscous extracts commonly used in Traditional Chinese Medicine (TCM). This technical specification focuses on critical requirements that ensure packaging integrity, minimize contamination risks, and maintain the quality of the contained viscous extracts throughout handling, storage, and use. Notably, the standard does not apply to solid dosage forms, concentrating solely on semi-liquid and semi-solid extracts.
Key Topics
ISO/TS 21758:2026 addresses several key areas relevant to manufacturers, quality assurance professionals, and regulatory authorities:
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External Appearance: Packaging must be free from contamination, physical damage, and ensure uniform shape and adhesion without film separation. Accurate and clear labeling is mandatory, aligning with ISO 21371.
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Heavy Metals in Combustion Test: Guarantees that heavy metal residues (as measured by the presence of lead) in the packaging materials do not exceed acceptable levels, protecting consumers from toxicity.
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Extractable Substances Testing:
- Foaming Test: Detects the presence of surfactants that may compromise product quality.
- pH Stability: Ensures the packaging does not alter the extract’s pH beyond specified limits.
- Potassium Permanganate Reducing Substances: Measures potential oxidizable substances leached from packaging, indicating cleanliness and chemical inertness.
- Residue on Evaporation: Confirms that minimal non-volatile contaminants are present after extraction.
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Test Methods: Provides standardized procedures for assessing compliance with the above requirements, ensuring reproducibility and accuracy across manufacturing and quality control environments.
Applications
ISO/TS 21758:2026 is widely applicable across the Traditional Chinese Medicine sector and other herbal extract industries:
- Manufacturers of Viscous Extracts: Ensures that stick-type, single-dose packages meet international safety and quality benchmarks, supporting global trade and acceptance.
- Quality Assurance & Regulatory Compliance: Facilitates easier validation during inspection, reducing non-compliance risk.
- Product Development: Offers guidelines for material selection and packaging design for single-use viscous herbal extracts such as ginseng, compound herbal pastes, and other semi-liquid TCM products.
- Consumer Safety: Minimizes contamination, ensuring the consistent delivery of potent and safe herbal medicine.
By adhering to this standard, organizations can demonstrate commitment to product safety and support regulatory submissions in various global markets.
Related Standards
Stakeholders interested in ISO/TS 21758:2026 may find these related standards useful for further guidance:
- ISO 21371:2018 - Traditional Chinese medicine - Labelling requirements of products intended for oral or topical use: Sets out comprehensive labeling criteria critical for packaged herbal products.
- World Health Organization TRS 902 - Annex 9: Offers packaging guidelines for pharmaceutical products, referenced for broader context.
- Korean Pharmacopoeia (12th edition) & Japanese Pharmacopoeia (18th edition): Provide foundational requirements for the assessment of plastics and other packaging materials in medicinal contexts.
Organizations already implementing these standards can integrate ISO/TS 21758:2026 to strengthen quality systems specific to stick-type packages for viscous herbal extracts.
By following ISO/TS 21758:2026, manufacturers and quality teams can ensure the structural integrity and chemical safety of TCM stick-pack packaging, ultimately protecting both product efficacy and consumer health. This standard is critical for advancing global trade and harmonization in the fast-evolving field of Traditional Chinese Medicine packaging.