ISO 19609-4-2022 PDF

Full title and description

ISO 19609-4:2022 — Traditional Chinese medicine — Quality and safety of raw materials and finished products made with raw materials — Part 4: Testing for preservatives and unwanted compounds. This part of ISO 19609 sets out requirements and guidance for testing preservatives and other unwanted compounds in starting materials and finished products used in and as Traditional Chinese Medicine (TCM).

Abstract

This document specifies testing considerations within a quality-control framework for the detection, identification and reporting of preservatives and unwanted compounds in raw materials and finished TCM products. It addresses sample selection and preparation, selection or development of analytical methods, and quality‑assurance measures to ensure reliable, reproducible results for use by manufacturers, quality laboratories and regulatory authorities.

General information

• Status: Published
• Publication date: 2 December 2022 (Edition 1, 2022-12)
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.120.10 (Medicaments / Traditional Chinese medicine)
• Edition / version: Edition 1 (2022)
• Number of pages: 22

Scope

ISO 19609-4:2022 applies to the testing of preservatives and unwanted compounds in starting materials (raw botanical, animal or mineral materials and ingredients) and finished products intended for use in or as Traditional Chinese Medicine. The standard is intended to be used within a broader quality‑management framework (see ISO 19609-1 and related parts) and focuses on analytical testing practices, sample handling and documentation needed to detect and control preservative residues and other unwanted chemical substances that may compromise safety or quality.

Key topics and requirements

• Purpose and applicability: testing to identify and quantify preservatives and unwanted compounds in raw and finished TCM products.
• Sample selection and handling: guidance on representative sampling, sample size, storage and transport to preserve analyte integrity.
• Sample preparation: recommended approaches to extraction, clean-up and preparation tailored to TCM matrices.
• Analytical methods: selection and validation of appropriate techniques (for example chromatographic and mass-spectrometric methods) suited to target analytes and matrix complexity.
• Method validation and performance: criteria for accuracy, precision, sensitivity (limits of detection/quantification), specificity and robustness.
• Acceptance criteria and reporting: how results should be interpreted, reported and recorded within a quality-control system.
• Quality assurance and traceability: laboratory quality controls, use of reference materials, calibration and documentation to support reliable testing.
• Integration with broader TCM quality requirements: alignment with the general requirements and identity/contaminant testing in other parts of the ISO 19609 series.

Typical use and users

Primary users include herbal product and TCM manufacturers, contract and in‑house analytical laboratories, regulatory and conformity assessment bodies, quality assurance professionals, and standards developers. The standard is used to establish or harmonize testing protocols, to evaluate supplier raw-material quality, and to support regulatory compliance and product safety programs.

Related standards

ISO 19609 is a multipart series; closely related documents include ISO 19609-1 (General requirements), ISO 19609-2 (Identity testing of constituents of herbal origin) and ISO 19609-3 (Testing for contaminants). Users may also need to refer to relevant pharmacopeial monographs and ISO guidance on analytical method validation and laboratory quality management.

Keywords

Traditional Chinese Medicine, TCM, preservatives, unwanted compounds, quality control, analytical testing, sample preparation, HPLC, GC‑MS, LC‑MS, method validation, ISO 19609, ISO/TC 249, raw materials, finished products.

FAQ

Q: What is this standard?

A: ISO 19609-4:2022 is an international standard that specifies testing considerations for preservatives and unwanted compounds in raw materials and finished products used in Traditional Chinese Medicine.

Q: What does it cover?

A: It covers sample selection and handling, sample preparation, selection and validation of analytical methods, quality assurance, acceptance criteria and reporting practices for detecting preservatives and unwanted chemical compounds in TCM matrices.

Q: Who typically uses it?

A: Manufacturers of TCM products, analytical and contract laboratories, quality assurance teams, regulatory authorities and conformity assessment bodies use it to harmonize testing and ensure product safety and traceability.

Q: Is it current or superseded?

A: ISO 19609-4 was published in December 2022 (Edition 1). It is a current standard; there were no published amendments or official withdrawals affecting it as of 28 February 2026.

Q: Is it part of a series?

A: Yes — it is Part 4 of the ISO 19609 series on quality and safety of raw materials and finished products made with raw materials for Traditional Chinese Medicine. Other parts include general requirements and guidance on identity testing and contaminants (Parts 1–3).

Q: What are the key keywords?

A: Traditional Chinese Medicine, preservatives, unwanted compounds, analytical testing, sample preparation, method validation, quality control, ISO 19609, ISO/TC 249.