Standards Development

Scope

This document provides general requirements for the measurement methods with quantitative nuclear magnetic resonance (qNMR), using the nuclear species hydrogen (1H), applied to purity determination of organic compounds used for foods and food products.

This document is applicable to determine the purities of food-related substances such as food additives, pesticides, natural toxins, and functional compounds.

This document provides general requirements and performance criteria for making the measurement results to ensure to be SI traceable.

Purpose

Background of the proposal

1) Accurate quantification of food components is important to secure food safety and assurance. Presently, chromatography, such as GC and HPLC is used in majority of legal regulations associated with food. For accurate quantification, it is important to use good standards, such as Certified Reference Material (CRM), which are SI traceable with accurate purity. However, based on using the existing methods such as the mass balance method, the preparation of SI-traceable CRMs has lots of trouble that make us difficult to obtain them. Therefore, we focused on the establishment of qNMR as an accurate and rapid method to produce SI traceable reference materials and standardized it in Japan. The methods that can obtain SI-traceable values are called the primary methods, and include isotopic dilution mass spectrometry, coulometric analysis, gravimetric analysis, titrimetric method, freezing point depression method, etc. At present, our established qNMR has the qualification of the primary ratio method that is one of the primary methods.

2) In 2018, an international summit was held to discuss international standardization of the qNMR (qNMR summit 2018 in Tokyo). The qNMR summit was first held by the United States Pharmacopoeia (USP) in October 2016, followed by German NMI, Federal Institute for Materials Research and Testing (BAM) holding the second summit in March 2017. The qNMR summit 2018 in Tokyo was attended by many experts and practitioners of the qNMR worldwide, and lectures and discussions were held over two days. As a result, a consensus was obtained from all attendees, and it was concluded in Japan that international standardization of the qNMR is inevitable to improve the accuracy of food analysis in future.

Through such background, a new proposal was made for TC 34 in Japan.