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,Hygroscopic Freely soluble in water | 白色或类白色粉末,有吸湿性,水中易溶 White or almost white powder,Hygroscopic Freely soluble in water | |
鉴别 Identification | 13C NMR Spectrum | 应符合规定 Should complied | 符合规定 complied |
HPLC | 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 Nucleotidic | A260≤0.20 A280≤0.15 | A260≤0.18 A280≤0.12 | |
酸碱度pH | 5.0~7.5 | 6.34 | |
蛋白质 Protein | ≤2.0% | ≤1.0% | |
重金属Heavy Metals | NMT 30ppm | 符合规定 complied | |
干燥失重Loss on drying | NMT 5.0% | 2.7% | |
细菌内毒素Bacterial endotoxins | 0.03USP U | 符合规定 complied |