State Administration for Market Regulation: Establish a batch of national standard substances in the field of life and health
2024-11-07
Recently, the State Administration for Market Regulation approved the establishment of a batch of national standard substances in the field of life and health, involving drug research and development, disease diagnosis, food safety, and other aspects. Among them, there are 39 national first level standard substances and 539 national second level standard substances. In terms of drug development, newly approved standards have been established for the purity of chiral amino acids such as D-isoleucine and D-aspartic acid, as well as standards for nano silver particle size. Taking D-isoleucine standard substance as an example, this standard substance can provide important guarantees for the quality control of chiral drug preparation, antibacterial, anti-tumor, and new broad-spectrum antibiotic drug synthesis. The newly approved nano silver particle size standard substance can provide a precise measurement material basis for the full chain research of related materials and products, provide a basis for the performance evaluation and risk assessment of nano pharmaceutical products, and promote the transformation and safe application of nano biomedical technology products. In terms of disease diagnosis, newly approved genetic testing standard substances such as monkeypox virus pseudovirus nucleic acid, adenovirus genomic DNA, and human papillomavirus deoxyribonucleic acid provide a "biological ruler" for medical diagnosis results, thereby providing technical support for effectively reducing the probability of "false negatives" in disease diagnosis. At the same time, these standard substances are widely used as measurement standards in the development and performance evaluation of virus detection kits, and can also provide traceability support for the export of domestic biological detection kits. In terms of food safety, new approval has been granted to establish standard substances for pesticide solutions such as thiamethoxam in acetonitrile, carbofuran in methanol, chlorpyrifos in methanol poisoning, and herbicide ether in n-hexane, as well as a matrix standard substance for chloramphenicol residue analysis in chicken powder. This will help improve the detection capability of pesticide and veterinary drug residues in food, ensure accurate, comparable, and traceable measurement results, and guarantee the safety of food for the general public. (New Society)
Edit:Chen Jie Responsible editor:Li Ling
Source:GuangMing Daily
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