| Title: | Development of a human insulin certified reference material with SI-traceable purity |
| Author(s): | Wang X; Wu L; Huang Y; Su P; Yang Y; Yang B; Zhang N; |
| Address: | "Beijing University of Chemical Technology, No. 15 North Third Ring Road, Chaoyang District, Beijing, 100029, China. National Institute of Metrology, No. 18 North Third Ring Road, Chaoyang District, Beijing, 100029, China. South China National Centre of Metrology/Guangdong Institute of Metrology, No. 30, Songbai East Street, Baiyun District, Guangzhou, 510405, Guangdong, China. Beijing University of Chemical Technology, No. 15 North Third Ring Road, Chaoyang District, Beijing, 100029, China. suping@mail.buct.edu.cn. Beijing University of Chemical Technology, No. 15 North Third Ring Road, Chaoyang District, Beijing, 100029, China. yangyi@mail.buct.edu.cn" |
| DOI: | 10.1007/s00216-022-03965-0 |
| ISSN/ISBN: | 1618-2650 (Electronic) 1618-2642 (Linking) |
| Abstract: | "A human insulin (hINS) certified reference material (CRM) was developed by the National Institute of Metrology (NIM). Three milligrams of purified solid hINS was packed into a brown sealed tube. The candidate material was identified by de novo sequence using mass spectrometry and Edman degradation methods. The content of insulin-related impurities, aggregation, moisture, volatile organic compounds (VOCs), anions, and ignition residues was also determined. Both mass balance (MB) and amino acid analysis-based isotope dilution mass spectrometry (AAA-IDMS) were used for the certified value assessment, which was determined to be (0.857 +/- 0.024) g/g. The certified value was validated by liquid chromatography-circular dichroism spectroscopy (LC-CD) and quantitative nuclear magnetic resonance (qNMR) methods, which were in good agreement. No inhomogeneity was observed during a homogeneity examination. A stability examination showed that the CRM was stable for at least 12 months when stored at - 70 degrees C, and for 7 days when stored at 4, 25, or 40 degrees C. The CRM is expected to be used as a primary calibrator for matrix insulin CRM development and for quality control in biopharmaceutical production and clinical diagnostics" |
| Keywords: | "*Amino Acids/analysis Chromatography, Liquid/methods Humans *Insulin Mass Spectrometry/methods Reference Standards Human insulin certified reference material Isotope dilution mass spectrometry Liquid chromatography-circular dichroism Mass balance;" |
| Notes: | "MedlineWang, Xianxia Wu, Liqing Huang, Yanjie Su, Ping Yang, Yi Yang, Bin Zhang, Ning eng Germany 2022/02/25 Anal Bioanal Chem. 2022 May; 414(11):3443-3457. doi: 10.1007/s00216-022-03965-0. Epub 2022 Feb 24" |
