ISO 23962:2021

Overview

ISO 23962:2021 - Traditional Chinese medicine - Processed Aconitum carmichaelii lateral root (Fuzi) is an international standard that sets minimum requirements and test methods for processed lateral root of Aconitum carmichaelii used as natural medicines in international trade. The standard applies to Chinese materia medica and decoction pieces derived from this plant (salted, black slice, white slice, boiled slice), but does not prescribe processing methods.

Keywords: ISO 23962:2021, Aconitum carmichaelii, Fuzi, traditional Chinese medicine, quality control, processed Aconitum.

Key topics and technical requirements

ISO 23962:2021 organizes technical control around identification, safety and quality testing:

• Descriptions and morphological features for common commercial forms (salted, black slice, white slice, boiled slice).
• Analytical requirements including moisture content, total ash and thin-layer chromatogram (TLC) identification.
• Marker compounds: control of six aconite alkaloids commonly used for quality and safety monitoring - Aconitine (AC), Mesaconitine (MA), Hypaconitine (HA) (toxic diester alkaloids) and Benzoylaconine (BAC), Benzoylmesaconine (BMA), Benzoylhypaconine (BHA) (monoester alkaloids).
• Contaminant limits and tests: heavy metals and pesticide residues, with referenced ISO methods.
• Sampling, test methods and reporting: macroscopic ID, HPLC determination of selected alkaloids (ISO 23191 referenced), moisture and ash methods (ISO 1575 referenced), TLC identification, roots number per 1000 g, and standardized test reporting.
• Packaging, storage and labelling requirements to support safe transport and use.

Related normative standards referenced include ISO 23191 (HPLC for aconitum alkaloids), ISO 22258 (pesticide residues), ISO 18664 (heavy metals), ISO 1575 (total ash), ISO 21371 (labelling) and ISO 22217 (storage).

Applications and practical value

ISO 23962:2021 is designed to:

• Improve consumer safety by reducing risk of aconitum poisoning through defined testing and marker monitoring.
• Harmonize quality control for international trade in processed Aconitum carmichaelii lateral root and decoction pieces.
• Provide laboratory test protocols and acceptance criteria for quality assurance and regulatory compliance.
• Support pharmacopoeias, manufacturers, exporters/importers, testing laboratories and regulatory authorities in establishing consistent product specifications.

Practical uses:

• Quality control labs use the specified TLC, HPLC and contaminant tests to verify safety and authenticity.
• Regulatory agencies adopt the standard to set import/export and market surveillance requirements.
• TCM producers and distributors apply sampling, labelling and storage requirements to ensure compliance and market access.

Who should use this standard

• Herbal product manufacturers and processors (sourcing and QC)
• Analytical and testing laboratories (HPLC, TLC, heavy metals, pesticides)
• National regulators and customs authorities (trade and safety oversight)
• Pharmacopeial bodies and TCM clinical users needing harmonized quality criteria

Related standards

• ISO 23191 - Determination of selected Aconitum alkaloids (HPLC)
• ISO 22258 - Determination of pesticide residues
• ISO 18664 - Determination of heavy metals
• ISO 1575 - Total ash determination
• ISO 21371 and ISO 22217 - Labelling and storage for TCM products

ISO 23962:2021 provides a practical framework for safe, consistent and internationally harmonized quality control of processed Aconitum carmichaelii lateral root.