{"title":"[The Human Insulin Reference Standard (Control 921) of the National Institute of Health Sciences].","authors":"C Yomota, M Ema, Y Ogawa, S Okada","doi":"","DOIUrl":null,"url":null,"abstract":"<p><p>Raw human insulin material was examined for preparation of the \"Human Insulin Reference Standard\". The candidate material was evaluated by a domestic collaborative study in which four laboratories participated. The biological activity was determined to be 26.0 Unit/mg against the International Human Insulin Reference Standard (Code 83/500), based on the rabbit blood-glucose method specified in the JP XII (1991). Because of the possibility of application as a chemical reference standard for assay by the HPLC method, a physico-chemical evaluation of the candidate material was also performed. The total desamide form, dimer and oligomer impurities were estimated to be about 1% by HPLC. Based on the above findings, this raw material was authorized as the Human Insulin Reference Standard of the National Institute of Health Sciences.</p>","PeriodicalId":11656,"journal":{"name":"Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences","volume":" 112","pages":"155-60"},"PeriodicalIF":0.0000,"publicationDate":"1994-01-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Eisei Shikenjo hokoku. Bulletin of National Institute of Hygienic Sciences","FirstCategoryId":"1085","ListUrlMain":"","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0
Abstract
Raw human insulin material was examined for preparation of the "Human Insulin Reference Standard". The candidate material was evaluated by a domestic collaborative study in which four laboratories participated. The biological activity was determined to be 26.0 Unit/mg against the International Human Insulin Reference Standard (Code 83/500), based on the rabbit blood-glucose method specified in the JP XII (1991). Because of the possibility of application as a chemical reference standard for assay by the HPLC method, a physico-chemical evaluation of the candidate material was also performed. The total desamide form, dimer and oligomer impurities were estimated to be about 1% by HPLC. Based on the above findings, this raw material was authorized as the Human Insulin Reference Standard of the National Institute of Health Sciences.