title: Development and co-validation of porcine insulin certified reference material by high-performance liquid chromatography-isotope dilution mass spectrometry.
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.
authors.affiliation: Division of Medical and Biological Measurements, National Institute of Metrology, No. 18 Bei San Huan Dong Lu, Chaoyang District, Beijing, 100013, China, wulq@nim.ac.cn.
authors.forename: Liqing
authors.initials: L
authors.lastname: Wu
authors.forename: Akiko
authors.initials: A
authors.lastname: Takatsu
authors.forename: Sang-Ryoul
authors.initials: SR
authors.lastname: Park
authors.forename: Bin
authors.initials: B
authors.lastname: Yang
authors.forename: Huaxin
authors.initials: H
authors.lastname: Yang
authors.forename: Tomoya
authors.initials: T
authors.lastname: Kinumi
authors.forename: Jing
authors.initials: J
authors.lastname: Wang
authors.forename: Jiaming
authors.initials: J
authors.lastname: Bi
authors.forename: Yang
authors.initials: Y
authors.lastname: Wang
mesh_terms: D002138:Calibration; D002681:China; D002851:Chromatography, High Pressure Liquid / Q000379:methods / Q000592:standards*; D006868:Hydrolysis; D061389:Insulin, Regular, Pork / Q000032:analysis / Q000592:standards*; D008970:Molecular Weight; D011865:Radioisotope Dilution Technique / Q000592:standards*; D012015:Reference Standards; D015203:Reproducibility of Results
chemical_list: D061389:Insulin, Regular, Pork