ISO 6904:2024 PDF

Name: ISO 6904:2024 — Traditional Chinese Medicine — General requirements for the ultrafine powder of herbs
SKU: ISO 6904:2024
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Traditional Chinese Medicine — General requirements for the ultrafine powder of herbs

Название (английский):

ISO 6904:2024

Traditional Chinese Medicine — General requirements for the ultrafine powder of herbs

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 6
Дата публикации:: 22 апреля 2024 г.
Издание:: ISO IS 6904 edition 1 version 1
ICS:: 11.120.10

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Описание (английский):

This document specifies general requirements for ultrafine powder of herbs to ensure their quality and safety. This document applies to ultrafine powder of herbs that are sold and used as natural medicines in international trade, including finished products derived from this powder.

Abstract

Overview

Key Topics

Scope and Applicability Applies to herbal powders with a particle size distribution (D90) not exceeding 45 µm, processed using modern pulverization techniques. These powders must originate from traditionally used decoction pieces verified through scientific research.
Identification and Assay Chemical components specific to each herb are defined and tested for authenticity using chromatographic methods like thin-layer chromatography (TLC), DNA molecular identification, and microscopic techniques.
Quality Control Parameters The standard sets detailed quality requirements including:
- Assay limits for active constituents to ensure consistent potency
- Determination of extractives (water, ethanol, and/or ether-based) for chemical profiling
- Moisture content limits aligned with regional or national pharmacopoeia requirements
- Uniform appearance to avoid discoloration and ensure product consistency
Safety Testing Extensive safety parameters cover:
- Pesticide residues
- Heavy metals content as per ISO/TC 249 guidelines
- Sulfur dioxide residues
- Mycotoxins and microbial contamination tests
- Specific toxic substances such as aristolochic acids and aconitum alkaloids
Particle Size Distribution Measurement of particle size distribution via dynamic light scattering (DLS) confirms the fine pulverization essential for effective and safe medicine absorption.
Packaging and Labeling Requirements ensure that finished products and powders are properly labeled, facilitating traceability and compliance with regulatory authorities.

Applications

ISO 6904:2024 has practical applications across various sectors that manufacture, regulate, or distribute TCM herbal products:

Traditional Chinese Medicine Manufacturers Producers can apply this standard to enhance powder product formulations, ensuring consistent quality and safety for international markets.
Quality Assurance and Regulatory Bodies Testing laboratories and regulators use ISO 6904 to establish uniform testing protocols and acceptance criteria for herbal powders imported or manufactured domestically.
International Trade and Export Harmonizing quality standards encourages global trade of ultrafine herbal powders by reducing trade barriers linked to quality and safety concerns.
Healthcare Providers and Consumers The standard promotes safer consumption by certifying that ultrafine powders meet identified chemical profiles and are free from hazardous contaminants.

Related Standards

ISO 6904:2024 references and complements several other ISO standards pertinent to Traditional Chinese Medicine and herbal product quality control:

ISO 18664 - Determination of heavy metals in herbal medicines
ISO 19609-2 - Identity testing of herbal constituents
ISO 21371 - Labelling requirements for oral and topical products
ISO 22258 - Determination of pesticide residues via gas chromatography
ISO 22283 - Determination of aflatoxins in natural products
ISO 22467 - Microorganism determination methods for natural products
ISO 22590 - Determination of sulfur dioxide residues
ISO 23190 - Determination of aristolochic acids by HPLC
ISO 23191 - Determination of selected Aconitum alkaloids by HPLC
ISO 23723 - General requirements for herbal raw material and materia medica

Together, these standards provide a comprehensive framework to ensure the quality, safety, and efficacy of traditional Chinese medicinal products in the form of ultrafine powders.

Keywords: ISO 6904:2024, Traditional Chinese Medicine, ultrafine powder of herbs, quality and safety standards, herbal powder particle size, pesticide residue testing, heavy metals in herbal medicine, mycotoxin analysis, herbal medicine packaging, TCM quality assurance, international herbal trade standards.

Технические детали

Технический комитет: ISO/TC 249 - Traditional Chinese medicine
SKU: ISO 6904:2024

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ISO 6904:2024 PDF

Abstract

Overview

Похожие стандарты

Key Topics

Applications

Related Standards

Технические детали

ISO 18664:2015

Traditional Chinese Medicine — Determination of heavy metals in herbal medicines used in Traditional Chinese…

ISO 19609-2:2021

Traditional Chinese medicine — Quality and safety of raw materials and finished products made with raw materi…

ISO 2137:1972

Petroleum products — Lubricating grease — Determination of cone penetration

ISO 22258:2020

Traditional Chinese medicine — Determination of pesticide residues in natural products by gas chromatography

ISO 22283:2020

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

ISO 22467:2021

Traditional Chinese medicine — Determination of microorganisms in natural products

ISO 22590:2020

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