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资料来源:FDA MedWatch Safety Alert 发布日期:2009.12月FDA通知医务人员和患者有关美国药典对肝素的新版专著。根据新版专著,用于测定肝素效价的参考标准将被更改,以与WHO国际标准完全接轨。尽管参考标准改变,肝素剂量会继续沿用美国药典中表述的单位。对近来肝素污染问题的部分回复,新版专著中还新加了附加试验方法可检测肝素中潜在的不纯净物和污染物。
Source: FDA MedWatch Safety Alert Date of release: December 2009 FDA alerts healthcare professionals and patients about a new monograph on the United States Pharmacopoeia for heparin. According to the new monograph, the reference standard for the determination of heparin titer will be changed to fully comply with WHO international standards. Despite the change in reference standard, the heparin dose will continue to be in the units stated in the U.S. Pharmacopeia. Part of the response to the recent heparin contamination issue, the new monograph also added an additional test method to detect potential impurities in pure heparin and contaminants.