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Analytical and Bioanalytical Chemistry

, Volume 407, Issue 11, pp 3125–3135 | Cite as

Development and co-validation of porcine insulin certified reference material by high-performance liquid chromatography–isotope dilution mass spectrometry

  • Liqing WuEmail author
  • Akiko Takatsu
  • Sang-Ryoul Park
  • Bin Yang
  • Huaxin Yang
  • Tomoya Kinumi
  • Jing Wang
  • Jiaming Bi
  • Yang Wang
Research Paper
Part of the following topical collections:
  1. Reference Materials for Chemical Analysis

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.

Keywords

Porcine insulin Certified reference material Liquid chromatography–isotope dilution mass spectrometry Co-validation 

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

Notes

Acknowledgement

This work was supported by the National Science & Technology Pillar Program of the Eleventh Five-Year Plan Period (2006DFB41610 and 2006BAK04A02).

Supplementary material

216_2014_8385_MOESM1_ESM.pdf (104 kb)
ESM 1 (PDF 103 kb)

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Copyright information

© Springer-Verlag Berlin Heidelberg 2014

Authors and Affiliations

  • Liqing Wu
    • 1
    Email author
  • Akiko Takatsu
    • 2
  • Sang-Ryoul Park
    • 3
  • Bin Yang
    • 1
  • Huaxin Yang
    • 4
  • Tomoya Kinumi
    • 2
  • Jing Wang
    • 1
  • Jiaming Bi
    • 5
  • Yang Wang
    • 5
  1. 1.Division of Medical and Biological MeasurementsNational Institute of MetrologyBeijingChina
  2. 2.National Metrology Institute of JapanNational Institute of Advanced Industrial Science and Technology (AIST)TsukubaJapan
  3. 3.Korea Research Institute of Standards and Science (KRISS)Center of BioanalysisDaejeonRepublic of Korea
  4. 4.National Institutes for Food and Drug ControlBeijingChina
  5. 5.College of ScienceBeijing University of Chemical TechnologyBeijingChina

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