ArticleAnalytical and bioanalytical chemistry2022
Development of a human insulin certified reference material with SI-traceable purity.
Article in Analytical and bioanalytical chemistry, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 6 papers.
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Who cites it
6 citing papers in PubMed.
- Development of a certified reference material for D-phenylalanine with evaluation of enantiomeric purity.Analytical and bioanalytical chemistry · 2024Article
- Development of an SI-traceable N-terminal pro-B-type natriuretic peptide certified reference material using structure-based impurity-corrected isotope dilution mass spectrometry approaches.Analytical and bioanalytical chemistry · 2024Article
- Development of cancer biomarker heat shock protein 90α certified reference material using two different isotope dilution mass spectrometry techniques.Analytical and bioanalytical chemistry · 2024Article
- A potential primary method for peptide purity analysis by gas chromatography-isotope dilution infrared spectrometry.Analytical and bioanalytical chemistry · 2023Article
- Production and Characterization of a SARS-CoV-2 Nucleocapsid Protein Reference Material.ACS measurement science au · 2022Article
- Measurement comparability of insulin assays using conventional immunoassay kits.Journal of clinical laboratory analysis · 2022Article
Corrections and comments
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Authors and funding
7 authors.
Funding
No grant is acknowledged in the PubMed record.
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 °C, and for 7 days when stored at 4, 25, or 40 °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.
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