Collaborative calibration to establish the 3rd National Standard for Un-fractionated Heparin
10.3969/j.issn.1005-1678.2017.04.005
- VernacularTitle:第3次肝素国家标准品协作标定
- Author:
Changhong MENG
;
Weifeng ZONG
;
Yihong LU
- Keywords:
heparin;
national standard;
collaborative study;
potency
- From:
Chinese Journal of Biochemical Pharmaceutics
2017;37(4):17-19
- CountryChina
- Language:Chinese
-
Abstract:
Objective To establish the 3rd 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 3rd 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 3rd national standard for un-fractionated Heparin with an assigned value of 2011IU per ampoule.
