[Elcatonin Reference Standard (Control 921) of National Institute of Health Sciences]

The raw material of elcatonin was examined for preparation of the "Elcatonin Reference Standard". The candidate material was evaluated by a domestic collaborative study in which five laboratories participated. The biological activity was determined to be 11.3 Unit/Amp. against the International Elcatonin Reference Standard (Code 84/614), based on one hour hypocalcaemia rat bioassay. In spite of the differences in rat strain, sex, administration method, dosage and assay method for serum calcium etc., the separately obtained biological activities for the candidate agreed closely with each other (95% confidence limits 11.08-11.53 Unit/Amp.). The physico-chemical evaluation of the candidate material was also performed, by using HPLC and amino acid chromatography. Based on the above results, this raw material was authorized to be the Elcatonin Reference Standard of the National Institute of Health Sciences.