UNIVERSITY OF MIYAZAKI;Fuso Pharmaceutical Industries, Ltd.
发明人:
申请号：
EP16191158.1
公开号：
EP3144325A1
申请日:
2011.09.13
申请国别(地区):
EP
年份:
2017
代理人:
摘要：
The present invention provides a heparin which does not substantially contain a nitrous acid degradation-resistant impurity, wherein, with respect to the peak total area value detected by refractive index (RI) which appears at the elution point of the heparin obtained when a reference heparin is analyzed by high performance liquid chromatography (HPLC), the peak total area value which appears at the elution point of the heparin which has been degraded with the above nitrous acid and analyzed by HPLC under the same conditions, is 5% or less,wherein the analysis is conducted by high performance liquid chromatography (HPLC) under the conditions disclosed in the "Molecular Weight" section in the "Parnaparin sodium" Standard Test Method described in The Japanese Pharmacopoeia, fifteenth edition.
