ISO 23965:2022 PDF

Name: ISO 23965:2022 — Traditional Chinese medicine — Bupleurum chinense, Bupleurum scorzonerifolium and Bupleurum falcatum root
SKU: ISO 23965:2022
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Traditional Chinese medicine — Bupleurum chinense, Bupleurum scorzonerifolium and Bupleurum falcatum root

Название (английский):

ISO 23965:2022

Traditional Chinese medicine — Bupleurum chinense, Bupleurum scorzonerifolium and Bupleurum falcatum root

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 20
Дата публикации:: 30 марта 2022 г.
Издание:: ISO IS 23965 edition 1 version 1
ICS:: 11.120.10

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Описание (английский):

This document specifies minimum requirements and test methods for Bupleurum chinense, Bupleurum scorzonerifolium and Bupleurum falcatum root. This document applies to Bupleurum chinense, Bupleurum scorzonerifolium and Bupleurum falcatum root that are sold and used as natural medicines in international trade, including Chinese materia medica (whole medicinal materials) and decoction pieces.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 23965:2022 - Traditional Chinese medicine - Bupleurum chinense, Bupleurum scorzonerifolium and Bupleurum falcatum root defines minimum quality requirements and test methods for Bupleuri Radix used as natural medicines and decoction pieces in international trade. The standard covers macroscopic description, sampling, laboratory testing and requirements for safety-relevant contaminants to support consistent, traceable quality of Bupleurum chinense, B. scorzonerifolium and B. falcatum root in global supply chains.

Key topics and technical requirements

Scope and description: Identification and morphological characteristics of the three Bupleurum species (root shape, size ranges, surface and fracture features).

Physical and chemical limits:

Moisture: mass fraction ≤ 10.0%
Total ash: mass fraction ≤ 9.0%
Acid‑insoluble ash: mass fraction ≤ 3.5%
Ethanol‑soluble extractives: mass fraction ≥ 11.0%

Chemical markers and identity testing:

TLC identification (thin‑layer chromatography) for marker compounds such as saikosaponin a (matching spot position and colour with reference).
Determination of marker compounds including saikosaponin a and d.

Contaminants and safety testing:

Heavy metals: arsenic, mercury, lead, cadmium (determination methods referenced).
Pesticide residues: e.g., benzene hexachloride (BHC), DDT, pentachloronitrobenzene.
Sulfur dioxide residues determination.
Identification of toxic adulterants (e.g., Bupleurum longiradiatum root fingerprinting).

Test methods and procedures: macroscopic ID, moisture, ash, ethanol‑soluble extractives, TLC, marker compound assay, heavy metals, pesticides, sulfur dioxide; plus sampling, test reporting, packaging, storage and labelling requirements.

Informative annexes: detailed guidance for test procedures and national/regional value variations.

Practical applications - who uses ISO 23965:2022

Manufacturers and processors of TCM materia medica and decoction pieces to ensure compliance and product consistency.

Quality control and analytical laboratories performing identity and contaminant testing.

Importers/exporters and traders in herbal products to meet international trade requirements and reduce risk of adulteration.

Regulators and pharmacopoeia committees aligning national requirements with an international baseline.

Clinical researchers and formulators needing validated reference methods and marker compound data for Bupleuri Radix.

Related standards

ISO 23965 cites several normative references for specific methods and requirements, including:

ISO 18664 (heavy metals in TCM),

ISO 21371 (labelling for oral/topical TCM products),

ISO 22258 (pesticide residues by GC),

ISO 22590 (sulfur dioxide determination),

ISO 23723 (general requirements for herbal raw material and materia medica).

Keywords: ISO 23965:2022, Bupleurum chinense, Bupleuri Radix, traditional Chinese medicine, TCM herb testing, saikosaponin, TLC identification, herbal quality control, heavy metals, pesticide residues.

ISO 23965:2022 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications - who uses ISO 23965:2022

Related standards

Технические детали

ISO 18664:2015

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

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 22590:2020

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

ISO 23723:2021

Traditional Chinese medicine — General requirements for herbal raw material and materia medica