Abstract
This article concerns the development and co-validation of a porcine insulin (pINS) certified reference material (CRM) produced by the National Institute of Metrology, People’s Republic of China. Each CRM unit contained about 15 mg of purified solid pINS. The moisture content, amount of ignition residue, molecular mass, and purity of the pINS were measured. Both high-performance liquid chromatography–isotope dilution mass spectrometry and a purity deduction method were used to determine the mass fraction of the pINS. Fifteen units were selected to study the between-bottle homogeneity, and no inhomogeneity was observed. A stability study concluded that the CRM was stable for at least 12 months at -20 °C. The certified value of the CRM was (0.892 ± 0.036) g/g. A co-validation of the CRM was performed among Chinese, Japanese, and Korean laboratories under the framework of the Asian Collaboration on Reference Materials. The co-validation results agreed well with the certified value of the CRM. Consequently, the pINS CRM may be used as a calibration material or as a validation standard for pharmaceutical purposes to improve the quality of pharmaceutical products.
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Abbreviations
- CRM:
-
Certified reference material
- GC:
-
Gas chromatography
- HPLC:
-
High-performance liquid chromatography
- IDMS:
-
Isotope dilution mass spectrometry
- KRISS:
-
Korea Research Institute of Standards and Science
- LC:
-
Liquid chromatography
- l-Phe:
-
l-Phenylalanine
- l-Val:
-
l-Valine
- MS:
-
Mass spectrometry
- NIM:
-
National Institute of Metrology
- NIST:
-
National Institute of Standards and Technology
- NMIJ:
-
National Metrology Institute of Japan
- pINS:
-
Porcine insulin
- Pro:
-
Proline
- RSD:
-
Relative standard deviation
- TFA:
-
Trifluoroacetic acid
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Acknowledgement
This work was supported by the National Science & Technology Pillar Program of the Eleventh Five-Year Plan Period (2006DFB41610 and 2006BAK04A02).
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Published in the topical collection Reference Materials for Chemical Analysis with guest editors Hendrik Emons and Stephen A. Wise.
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Wu, L., Takatsu, A., Park, SR. et al. Development and co-validation of porcine insulin certified reference material by high-performance liquid chromatography–isotope dilution mass spectrometry. Anal Bioanal Chem 407, 3125–3135 (2015). https://doi.org/10.1007/s00216-014-8385-4
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DOI: https://doi.org/10.1007/s00216-014-8385-4