Collaborative calibration to establish the 3rd National Standard for Un-fractionated Heparin / 中国生化药物杂志

ABSTRACT

Objective To establish the 3rd national standard for un-fractionated heparin for National Institutes for Food and Drug Control(NIFDC).MethodsFour candidate heparin samples(code ampoule 1,2,3,4)were assayed against the International Standard(07/328)and National Standard(150509-200912).Jiangsu Institute for Food and Drug Control(JSIFDC)determined the potency of anti-FXa and anti-FIIa by chromogenic substrate methods and the potency of anticoagulation by whole rabbit blood of Chinese Pharmacopoeia(2015).Results All of the data from our institute were adopted to calculate the 3rd national standard for un-fractionated Heparin.NIFDC analyzed the data from 13 laboratories.The geometric coefficient of variation of inter-laboratory and intra-laboratory were both below 10％.Conclusion Approved by the national drug standards material Committee,the candidate(140817-201501)was recommended to be the 3rd national standard for un-fractionated Heparin with an assigned value of 2011IU per ampoule.