ISO 4754-2022 PDF

Full title and description

ISO 4754:2022 — Traditional Chinese medicine — Fermented Cordyceps powder. An international standard that specifies quality requirements and test methods for fermented Cordyceps powder produced by liquid fermentation of extracted strains of Ophiocordyceps sinensis (Berk.).

Abstract

This document defines a set of requirements and analytical/test methods to control the quality, safety and identity of fermented Cordyceps powder. Key test items include identification, assay (potency/marker compounds), water content (loss on drying), residue on ignition (ash), microbial limits, and limits for heavy metals and other contaminants. The standard is intended to support consistent product specification, quality control and regulatory assessment of fermented Cordyceps powder used in traditional Chinese medicine (TCM) products.

General information

• Status: Published
• Publication date: November 2022 (ISO publication: 2022-11)
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.120.10 — Medicaments / Traditional Chinese medicine
• Edition / version: Edition 1 (2022)
• Number of pages: 16

Scope

ISO 4754:2022 applies to fermented Cordyceps powder produced by liquid fermentation using an extracted strain of Ophiocordyceps sinensis (Berk.). The standard establishes product definitions, essential quality attributes and methods for sampling and testing to determine identity, purity, content (assay), moisture, ash (residue on ignition), microbial contamination and heavy metal contaminants. It is not intended to cover unfermented raw materials, other Cordyceps formulations or finished multi-ingredient products unless explicitly referenced.

Key topics and requirements

• Definition and product description of fermented Cordyceps powder (source organism and fermentation process context).
• Identity testing requirements (organoleptic checks and defined chemical/analytical identification methods).
• Assay/marker-compound requirements to establish potency and compositional expectations.
• Limits for water content (loss on drying) and residue on ignition (ash).
• Microbiological quality criteria and recommended microbial limit tests.
• Limits and test methods for heavy metals and other chemical contaminants.
• Sampling procedures, test-method references and criteria for conformity.
• Requirements for labelling, packaging and traceability to support quality assurance.

Typical use and users

Primary users are manufacturers and processors of fermented Cordyceps powder, quality-control and analytical laboratories, regulatory agencies and import authorities assessing product safety and compliance, product purchasers and suppliers (for vendor qualification), and research and development teams benchmarking product quality. The standard helps define release criteria, supplier specifications and testing programs for commercial production and trade.

Related standards

ISO 4754:2022 is part of the ISO/TC 249 portfolio of standards for traditional Chinese medicine. Relevant related standards and documents include ISO traceability and labeling standards for Chinese materia medica, and standards or test-method references for moisture/loss-on-drying, residue on ignition (ash), microbial testing and heavy-metal analysis used in herbal and medicinal-product quality control. Implementers commonly reference other ISO and national pharmacopeial methods for specific analytical procedures and limits.

Keywords

fermented Cordyceps powder; Ophiocordyceps sinensis; traditional Chinese medicine; TCM; quality control; assay; identification; moisture content; residue on ignition; ash; microbial limits; heavy metals; ISO/TC 249.

FAQ

Q: What is this standard?

A: ISO 4754:2022 is an International Standard that specifies quality requirements and test methods for fermented Cordyceps powder used in traditional Chinese medicine.

Q: What does it cover?

A: It covers definition and description of the product, identity and assay tests, moisture and ash limits, microbial quality criteria, heavy-metal limits, sampling and test methods, and requirements supporting packaging and traceability for fermented Cordyceps powder produced by liquid fermentation of Ophiocordyceps sinensis extracts.

Q: Who typically uses it?

A: Manufacturers, contract and in‑house analytical laboratories, regulators and import authorities, suppliers and purchasers in the herbal/TCM supply chain, and R&D teams developing or benchmarking fermented Cordyceps products.

Q: Is it current or superseded?

A: ISO 4754:2022 is a current published International Standard (published November 2022). Users should check with the official standards publisher or their national standards body for any amendments or revisions after 2022.

Q: Is it part of a series?

A: It belongs to the ISO/TC 249 family of standards for traditional Chinese medicine and is used alongside other TCM standards (for raw materials, testing, traceability and product-specific requirements).

Q: What are the key keywords?

A: Fermented Cordyceps powder, Ophiocordyceps sinensis, TCM, quality control, assay, microbial limits, heavy metals, residue on ignition.