Establishment of the proposed 1st national standard reference for human urinary follicle stimulating hormone, urofollitropin, by bioassay
WU Yan-lin
ZHANG Yuan
WAN Long-yan
WANG Pei-hua
TANG Li-ming
WANG Qiao-xu
YU De-zhi
YI Xue-tao
GAO Hua
Abstract：Objective:To establish the 1st national standard for human urinary follicle stimulating hormone,urofollitropin,by bioassay.Methods:The biological potency of the 1st national standard candidate for human urofollitropin was collaboratively calibrated by 4 laboratories by the method in 1216 in ChP (Volume Ⅳ,2015 edition),taking the 1 st international standard for urofollitropin (IS 92/5 t2) as reference,which was provided by National Institute for Biological Standard and Control (NIBSC).The concentration of the candidate was determined by HPLC.Results:Relative to the 1 st international standard,the biological potency of the proposed 1st national standard candidate was 213 IU per ampoule,which the purity is 100％.Conclusion:The candidate was established as the 1st national standard for urofollitropin,which can be used for the bioassay of potency of urofollitropin and related products.
Keywords：urofollitropinfollicle stimulating hormonehuman menopausal gonadotropinbioassaynational standard
Publication Date：2017-01-01
Online Publishing Date：2026-08-14(First online date of this platform, not the publication date of the document)
Pages：4( 2376-2379 )