ISO 23191-2020 PDF

Full title and description

ISO 23191:2020 — Traditional Chinese medicine — Determination of selected Aconitum alkaloids by high-performance liquid chromatography (HPLC). This International Standard specifies analytical methods using HPLC for the identification and quantification of selected Aconitum alkaloids in traditional Chinese medicine materials and preparations.

Abstract

ISO 23191:2020 defines procedures for sample preparation, chromatographic separation and instrumental conditions, calibration, and result reporting to determine selected Aconitum‑type alkaloids (including aconitine, mesaconitine, hypaconitine, benzoylaconine, benzoylmesaconine, benzoylhypaconine, yunaconitine, deacetyl‑yunaconitine and crassicauline A) by high‑performance liquid chromatography. The standard supports accurate, reproducible quantification for quality control and safety assessment of TCM products.

General information

• Status: Published.
• Publication date: July 2020 (published 29 July 2020 in many catalogs).
• Publisher: International Organization for Standardization (ISO), prepared by ISO/TC 249 (Traditional Chinese medicine).
• ICS / categories: 11.120.10 (Medicaments; Traditional Chinese medicine).
• Edition / version: Edition 1 (2020).
• Number of pages: 15 pages.

Scope

The standard applies to the determination of selected Aconitum alkaloids in materials and finished traditional Chinese medicine (TCM) products where these analytes are relevant for safety and quality control. It provides validated HPLC‑based procedures covering sample extraction/preparation, chromatographic separation, calibration and quantification, and recommendations for reporting results to support consistent laboratory practice.

Key topics and requirements

• Target analytes: aconitine, mesaconitine, hypaconitine, benzoylaconine, benzoylmesaconine, benzoylhypaconine, yunaconitine, deacetyl‑yunaconitine, crassicauline A.
• Sample preparation and extraction procedures suitable for TCM raw materials and preparations.
• HPLC method requirements: chromatographic separation, detection and conditions sufficient for identification and quantification of the specified alkaloids.
• Calibration, use of reference standards, calculation of results, and criteria for method performance (precision, accuracy, system suitability).
• Reporting format and interpretation guidance for QC and regulatory use (traceability of results, units, uncertainty considerations).

Typical use and users

Analytical and quality‑control laboratories, manufacturers of traditional Chinese medicine products, regulatory authorities, pharmacopoeial committees, and research organizations use this standard to ensure reliable measurement of toxic Aconitum alkaloids for product safety, batch release testing, and regulatory compliance.

Related standards

Related documents include other ISO/TC 249 standards on quality and safety of TCM materials and products, pharmacopoeial monographs addressing herbal safety and alkaloid testing, and general laboratory/testing standards such as ISO/IEC 17025 (competence of testing and calibration laboratories) for laboratories implementing the methods. Users should consult relevant national pharmacopoeias and ISO/TC 249 publications for complementary methods and requirements.

Keywords

Aconitum; aconitine; mesaconitine; hypaconitine; benzoylaconine; yunaconitine; HPLC; high‑performance liquid chromatography; Traditional Chinese medicine; TCM; alkaloids; quality control; analytical method.

FAQ

Q: What is this standard?

A: ISO 23191:2020 is an ISO technical standard that specifies HPLC methods for determining selected Aconitum alkaloids in traditional Chinese medicine materials and preparations.

Q: What does it cover?

A: It covers sample preparation, chromatographic separation, calibration, quantification and reporting for a defined list of Aconitum alkaloids, with method performance and system suitability guidance to support accurate and reproducible results.

Q: Who typically uses it?

A: QC and analytical laboratories, TCM product manufacturers, regulatory agencies and pharmacopoeial bodies use the standard to test products for safety and to support regulatory compliance and product release.

Q: Is it current or superseded?

A: ISO 23191:2020 was published in 2020 and is the first edition; ISO standards are subject to periodic review (typically every five years). Users should check with ISO or their national standards body for the most recent status before relying on the standard for regulatory purposes.

Q: Is it part of a series?

A: The standard is one of a set of ISO/TC 249 deliverables addressing quality, safety and testing of traditional Chinese medicine; it is not numbered as a multipart series but complements other TCM and analytical standards.

Q: What are the key keywords?

A: Key keywords are Aconitum, aconitine, alkaloids, HPLC, Traditional Chinese medicine, TCM, quality control, analytical method.