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

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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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Authors and Affiliations

  1. Division of Medical and Biological Measurements, National Institute of Metrology, No. 18 Bei San Huan Dong Lu, Chaoyang District, Beijing, 100013, China

    Liqing Wu, Bin Yang & Jing Wang

  2. National Metrology Institute of Japan, National Institute of Advanced Industrial Science and Technology (AIST), 1-1-1 Umezono C3-9, Tsukuba, Ibaraki, 305-8563, Japan

    Akiko Takatsu & Tomoya Kinumi

  3. Korea Research Institute of Standards and Science (KRISS), Center of Bioanalysis, 1 Doryong-dong, Yusung-gu, Daejeon, 305-340, Republic of Korea

    Sang-Ryoul Park

  4. National Institutes for Food and Drug Control, No. 2, Tiantan Xili, Chongwen District, Beijing, 100050, China

    Huaxin Yang

  5. College of Science, Beijing University of Chemical Technology, Chao Yang District, Beijing, 100029, China

    Jiaming Bi & Yang Wang

Authors
  1. Liqing Wu
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  2. Akiko Takatsu
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  3. Sang-Ryoul Park
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  4. Bin Yang
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  5. Huaxin Yang
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  6. Tomoya Kinumi
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  7. Jing Wang
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  8. Jiaming Bi
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  9. Yang Wang
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Corresponding author

Correspondence to Liqing Wu.

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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

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