ISO 4754:2022 PDF

Name: ISO 4754:2022 — Traditional Chinese medicine — Fermented Cordyceps powder
SKU: ISO 4754:2022
Price: 25 EUR
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Traditional Chinese medicine — Fermented Cordyceps powder

Название (английский):

ISO 4754:2022

Traditional Chinese medicine — Fermented Cordyceps powder

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 16
Дата публикации:: 18 ноября 2022 г.
Издание:: ISO IS 4754 edition 1 version 1
ICS:: 11.120.10

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Описание (английский):

This document specifies a set of requirements and a test method to control the quality of fermented Cordyceps powder, including test items such as identification, assay, water content, residue on ignition, microbial limit and heavy metals. It is applicable to fermented Cordyceps powder which is produced by liquid fermentation with extracted strain of Ophiocordyceps sinensis (Berk.).

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 4754:2022 - Traditional Chinese medicine - Fermented Cordyceps powder specifies requirements and test methods to control the quality of fermented Cordyceps powder produced by liquid fermentation of an extracted strain of Ophiocordyceps sinensis (Berk.). The standard defines identification tests, quantitative assays, safety limits and reporting requirements to ensure consistent quality and safety of this Traditional Chinese Medicine (TCM) ingredient.

Key topics and technical requirements

Scope and applicability: Applies to dried mycelium powder obtained by liquid fermentation of Ophiocordyceps sinensis.

Identification methods:

Thin-layer chromatography (TLC) - Annex A
High-performance liquid chromatography (HPLC) - Annex B
DNA sequencing (normative) for strain confirmation - Annex C
Amino acid analyser profiles for key amino acids

Chemical and content requirements:

Total amino acids: not less than 30.0%
Mannitol: not less than 7.0%
Adenosine: not less than 0.08%
HPLC retention-time matching for adenosine and uridine; concordant peak patterns

Physical and compositional limits:

Loss on drying: ≤ 6.0%
Residue on ignition (ash): ≤ 7.0%

Safety and contaminant testing:

Heavy metals: determine arsenic, lead, cadmium, mercury (testing per ISO 18664)
Microbial limits: TAMC, TYMC and Escherichia coli (per ISO 22467)
Aflatoxins: determine AFB1 and total aflatoxins (per ISO 22283)

Test methods and reporting: Detailed procedures referenced or provided in annexes, with a required test report that cites ISO 4754:2022 and lists methods and calculated results.

Practical applications and users

Manufacturers of fermented Cordyceps powder and finished TCM products use ISO 4754:2022 to define product specifications and QC release criteria.

Analytical and contract testing laboratories implement the standard’s TLC, HPLC, DNA sequencing and chemical assays to verify identity, potency and purity.

Regulators and import authorities reference this standard when assessing product safety, heavy metal limits, microbial quality and aflatoxin compliance.

R&D teams and product formulators use the standard to benchmark fermented Cordyceps quality (adenosine, mannitol, amino acids) and to ensure reproducible fermentation outcomes.

Suppliers and buyers adopt the standard to support traceability and vendor qualification in the supply chain.

Related standards (referenced)

ISO 1762 - residue (ash) on ignition

ISO 6673 - loss on drying

ISO 13903 - amino acid determination

ISO 18664 - heavy metals in TCM

ISO 22283 - aflatoxins by LC-FLD

ISO 22467 - microorganisms in natural products

Keywords: ISO 4754:2022, fermented Cordyceps powder standard, Traditional Chinese Medicine quality control, HPLC, TLC, adenosine, mannitol, heavy metals, aflatoxins, microbial limits.

ISO 4754:2022 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications and users

Related standards (referenced)

Технические детали

ISO 18664:2015

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

ISO 22467:2021

Traditional Chinese medicine — Determination of microorganisms in natural products

ISO 22283:2020

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

SIST ISO 1762:2023

Paper, board, pulps and cellulose nanomaterials - Determination of residue (ash content) on ignition at 525 °C

SIST ISO 6673:2011

Green coffee -- Determination of loss in mass at 105 degrees C

SIST EN ISO 13903:2005

Animal feeding stuffs - Determination of amino acids content (ISO 13903:2005)