检测项目Test Item标准规定Specification检测结果Result性状Appearance白色或类白色粉末，有吸湿性，水中易溶White or almost white powder,HygroscopicFreely soluble in water白色或类白色粉末，有吸湿性，水中易溶White or almost white powder,HygroscopicFreely soluble in water鉴别Identification13C NMR Spectrum应符合规定Should complied符合规定compliedHPLC应符合规定Should complied符合规定complied分子量分布Molecular distribution Mw=7200~13500D 11200D效价potency Anti-FⅩa:≥180IU/mg  205IU/mg 核苷酸 NucleotidicA260≤0.20A280≤0.15A260≤0.18A280≤0.12酸碱度pH5.0~7.56.34蛋白质 Protein≤2.0%≤1.0%重金属Heavy MetalsNMT 30ppm符合规定complied干燥失重Loss on dryingNMT 5.0%2.7%细菌内毒素Bacterial endotoxins0.03USP U符合规定complied

检测项目Test Iterm标准规定Specification检测结果Results性状Appearance白色或类白色粉末，有吸湿性，水中易溶White or almost white powder,HygroscopicFreely soluble in water符合规定Complied1,6-脱水结构1,6-anhydro derivative15-25%18.9%鉴别Identification13C NMR Spectrum应符合规定Should complied符合规定complied分子量分布Molecular WeightMw=3800~5000D4430DM³8000 <18%11.6%M2000~8000=68.0~82.0%70.5%M£2000=12.0~20.0%17.9%Anti-FⅩa/ Anti-FⅡa3.3~5.34.14效价PotencyAnti-FⅩa:90~125IU/mg115.2 IU/mg Anti-FⅡa:20~35IU/mg27.8 IU/mg溶剂残留Residual solventsDMFNMT 880 ppm未检出Not Detected乙醇NMT 5000 ppm750 ppmH2O2残留Residual H2O2 in 10% of Aqueous solution< 0.5 ppm符合规定compliedSO42-/COO-NLT 1.82.1游离硫Free Sulfate ContentNMT0.5%0.2%氮 Nitrogen1.8%~2.5%2.1%钠 Sodium11.3%~13.5%12.2%pH (10% Aqueous solution)6.2~7.76.9

检测项目Test Iterm标准规定Specification检测结果Results性状Appearance白色或类白色粉末，有吸湿性，水中易溶White or almost white powder,HygroscopicFreely soluble in water类白色粉末，有吸湿性，水中易溶White or almost white powder,HygroscopicFreely soluble in water鉴别Identification1C NMR Spectrum应符合规定Should complied符合规定compliedHPLC应符合规定Should complied符合规定complied平均分子量Average Molecular WeightMW=8000~15000D12450D Anti-FⅩa/ Anti-FⅡa0.9~1.11.0效价potencyAnti-F Xa: ≥ 180 IU/mg190 IU/mg核苷酸 NucleotidicA260≤0.20A280≤0.15A260= 0.18A280= 0.12氮含量 Nitrogen content1.3~2.5%2.0%酸碱度pH5.0~7.56.5蛋白质 Protein≤2.0%0.8%重金属 Heavy MetalsNMT 30ppm符合规定complied干燥失重 Loss on dryingNMT 5.0%2.4%细菌内毒素Bacterial endotoxins0.03USP U符合规定complied

木聚硫钠  ，戊糖多硫酸钠 Pentosan Polysulfate SodiumItemsSpecificationsResultsAppearanceWhite or off white powderOff white powderIdentification1H- NMR spectrumCompliedAverage MW4000-7000 Daltons        5530Content of LMW componentNMT 12.0 %     8.6%Ph 4.5 to 6.55.5Sulphur content  13.0 to 20.0 wt%15.3%D-Glucuronic acid content（半乳糖醛酸）7.0 to 12.0 wt%9.3%Heavy metalsNMT 30 ppmPassedSolubilitySoluble in water, sparingly soluble in 0.1 N NaOH solution and practivally insoluble in methanolResultsThe product conforms to the above specifications