ISO 23191:2020

Overview

ISO 23191:2020 provides a comprehensive framework for the determination of selected Aconitum alkaloids in traditional Chinese medicine using high-performance liquid chromatography (HPLC). This standard is essential for ensuring the quality and safety of herbal products containing Aconitum species, which are known for their potent pharmacological effects. The standard outlines the methodology for the extraction, separation, and quantification of these alkaloids, facilitating compliance with regulatory requirements.

Key Requirements

The standard specifies a series of critical requirements that must be adhered to when conducting analyses of Aconitum alkaloids. These include:

• Sample Preparation: Detailed procedures for the extraction of alkaloids from herbal samples to ensure accurate results.
• Chromatographic Conditions: Specifications for HPLC settings, including column type, mobile phase composition, and flow rates.
• Calibration and Validation: Guidelines for the calibration of instruments and validation of methods to ensure reliability and reproducibility of results.
• Reporting Results: Standardised formats for reporting findings, including quantification limits and uncertainty assessments.

Implementation Benefits

Adopting ISO 23191:2020 offers numerous benefits for organisations involved in the production and analysis of traditional Chinese medicine. Key advantages include:

• Enhanced Quality Control: Implementing this standard improves the quality assurance processes, ensuring that products are safe for consumer use.
• Regulatory Compliance: Compliance with ISO 23191:2020 helps organisations meet national and international regulatory requirements, reducing the risk of non-compliance penalties.
• Improved Analytical Accuracy: The standardised methodology enhances the accuracy and reliability of analytical results, promoting confidence in product quality.
• Market Competitiveness: Adhering to recognised standards can improve marketability and consumer trust in herbal products.

Compliance Value

ISO 23191:2020 serves as a vital tool for compliance professionals in the health care technology sector. By following this standard, organisations can ensure that their products meet the necessary safety and efficacy criteria. The implications of non-compliance can be severe, including legal repercussions and damage to reputation. Therefore, integrating ISO 23191:2020 into quality management systems is not only advisable but essential for maintaining operational integrity and consumer safety.

In conclusion, ISO 23191:2020 is a critical standard for the determination of Aconitum alkaloids in traditional Chinese medicine. Its implementation supports quality assurance, regulatory compliance, and analytical precision, ultimately contributing to the safety and efficacy of herbal products.