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