ISO 23190-2021 PDF

Full title and description

ISO 23190:2021 — Traditional Chinese medicine — Determination of aristolochic acids in natural products by high-performance liquid chromatography (HPLC). This International Standard specifies an HPLC-based analytical method for detecting aristolochic acid I in raw herbal materials and finished herbal products used in traditional Chinese medicine (TCM), including sample preparation, chromatographic conditions, system suitability and guidance on result evaluation and confirmation.

Abstract

This document provides a standardized procedure for the qualitative and semi‑quantitative determination of aristolochic acid I in natural products using high‑performance liquid chromatography (HPLC), with recommendations for sample extraction, chromatographic parameters, system suitability criteria and validation/confirmation (including LC‑MS confirmation where appropriate). The method is intended to help laboratories identify a known nephrotoxic and carcinogenic compound in TCM materials.

General information

• Status: Published (International Standard).
• Publication date: June 2021 (publication recorded 9 June 2021).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.120.10 (Medicaments / Traditional Chinese medicine).
• Edition / version: Edition 1 (2021).
• Number of pages: 11 pages.

Metadata and publication details from the ISO catalogue and standards summaries.

Scope

Specifies an HPLC method for the detection of aristolochic acid I in natural products used in Traditional Chinese medicine. The scope covers sample preparation for raw herb powders and extracts/solid formulations, chromatographic separation and detection, system suitability checks, criteria for acceptance of results and recommendations for confirmation (for example by LC‑MS) and method validation (limits of detection, repeatability, recovery, etc.). The standard is intended for use in quality control and safety testing laboratories analysing TCM materials.

Key topics and requirements

• Target analyte: aristolochic acid I (primary analyte addressed).
• Analytical technique: high‑performance liquid chromatography (HPLC) with UV/DAD detection (typical detection at ~254 nm) and recommended system configuration (pump, degasser, autosampler, column compartment, diode array detector).
• Chromatographic recommendations: reversed‑phase C18 (octadecyl) columns or equivalent; mobile phases and gradient conditions given in annexes (example mobile phases include acetonitrile and aqueous acidified phase such as 0.05% phosphoric acid).
• Sample preparation: procedures for extracting powdered raw material and extracts/solid formulations (solvent extraction, ultrasonication, filtration, concentration/reconstitution where applicable).
• System suitability and acceptance criteria: retention time reproducibility, relative standard deviation limits and chromatographic resolution requirements.
• Validation and performance: guidance on limit of detection (LOD), repeatability, recovery (typical recovery expectations noted in method guidance), stability and expression of results.
• Confirmation: recommendation to confirm positive/ambiguous results by a confirmatory technique such as LC‑MS (described in an annex).

Technical details and typical parameter examples are described in the standard and supporting summaries.

Typical use and users

Used by analytical and quality control laboratories, regulatory agencies, manufacturers of herbal products and research institutions concerned with the safety and quality of Traditional Chinese medicine. Typical applications include routine screening of raw materials and finished products, safety compliance testing, and reference testing where aristolochic acid risk must be assessed.

Related standards

ISO 23190:2021 is part of ISO/TC 249 work on Traditional Chinese medicine. Related ISO standards include ISO 23191:2020 (Determination of selected Aconitum alkaloids by HPLC) and other TCM method standards and test methods developed under ISO/TC 249/SC 1. National and regional pharmacopeial methods for aristolochic acids and related compound testing may also be relevant when implementing laboratory procedures.

Keywords

aristolochic acid, aristolochic acid I, HPLC, high‑performance liquid chromatography, Traditional Chinese medicine, TCM, method validation, sample preparation, LC‑MS confirmation, ISO 23190:2021.

FAQ

Q: What is this standard?

A: ISO 23190:2021 is an International Standard that specifies an HPLC method for the determination of aristolochic acid I in natural products used in Traditional Chinese medicine.

Q: What does it cover?

A: It covers sample preparation, chromatographic conditions, system suitability criteria, validation guidance (LOD, repeatability, recovery), expression of results and recommendations for confirmation (for example by LC‑MS). The method is intended for detection and semi‑quantitative assessment of aristolochic acid I in raw materials and finished TCM products.

Q: Who typically uses it?

A: Analytical/quality control laboratories, regulatory bodies, manufacturers of herbal products and researchers working on TCM safety and quality use this standard to screen for and assess the presence of aristolochic acid I.

Q: Is it current or superseded?

A: ISO 23190:2021 was published in June 2021 and is the first edition (Edition 1, 2021). As of publication it is the current ISO standard for this method; users should check the ISO catalogue or national standards body for any subsequent amendments or withdrawals.

Q: Is it part of a series?

A: It forms part of the portfolio of ISO standards developed by ISO/TC 249 (Traditional Chinese medicine) and sits alongside related HPLC method standards such as ISO 23191:2020. The committee maintains multiple method standards for different toxic or active constituents in TCM.

Q: What are the key keywords?

A: Aristolochic acid, HPLC, Traditional Chinese medicine, TCM, chromatographic method, method validation, LC‑MS (confirmation).