ISO 23191:2020

Overview

ISO 23191:2020 - Traditional Chinese medicine - Determination of selected Aconitum alkaloids by high-performance liquid chromatography (HPLC) - defines validated laboratory procedures for measuring key toxic and marker alkaloids in Aconitum herbs and products. The standard covers the simultaneous determination of nine Aconitum alkaloids (aconitine, mesaconitine, hypaconitine, benzoylaconine, benzoylmesaconine, benzoylhypaconine, yunaconitine, 8‑deacetyl‑yunaconitine and crassicauline A) using HPLC with either mass spectrometric (HPLC‑MS) or diode‑array UV detection (HPLC‑DAD).

Key topics and requirements

• Analytes in scope: AC, MA, HA, BAC, BMA, BHA, YAC, DYA and CCA (named in the document).
• Analytical principle: Reverse‑phase HPLC on C18 (octadecylsilane) columns with a mobile phase system (0.1% formic acid / acetonitrile) and detection by ESI‑MS or UV DAD.
• Preferred method: HPLC‑MS is the primary method and is recommended for sensitive analytes (DYA, YAC, CCA); HPLC‑DAD is allowed as an optional method when validated and consistent with MS results.
• Reagents and apparatus: Specifies analytical‑grade solvents, sample prep reagents and typical instrumentation (e.g., 2.1 × 100 mm, 1.7 µm C18 column, ultrasonic bath, 0.22 µm filters).
• Sampling and sample size: Sampling follows WHO “Quality control methods for herbal materials” guidelines; pooled samples not less than 250 g with quartering to obtain representative test portions.
• Test procedures and reporting: Detailed procedures for reference solutions, test solutions, chromatographic and MS/DAD conditions, determination and test reporting are included. Annexes provide typical HPLC conditions, example chromatograms, common Aconitum herbs and national reference values (informative).

Applications and users

ISO 23191:2020 is designed for practical use in:

• Quality control laboratories in the herbal medicine and TCM supply chain
• Regulatory agencies and public health laboratories monitoring Aconitum toxicity
• Manufacturers of traditional Chinese medicine formulations performing release testing
• Academic and research labs validating HPLC methods for Aconitum alkaloids
• Pharmacopeial and standards organizations harmonizing test methods and limits

Practical benefits include standardized, internationally recognized procedures for accurate quantification of toxic alkaloids, enhanced consumer safety, and improved comparability of results across laboratories and jurisdictions.

Related standards and references

• ISO 3696 - Water for analytical laboratory use (specified grade of water)
• World Health Organization - Quality control methods for herbal materials (sampling guidance)
• AOAC Official Method references (methodologies for aconitine group detection)

Keywords: ISO 23191:2020, Aconitum alkaloids, HPLC, HPLC‑MS, HPLC‑DAD, traditional Chinese medicine, quality control, herbal safety, aconitine.