肝素钠
中文通用名 | ：肝素钠 |
用途类型 | ：抗凝血药 |
规格 | ：USP |
HS Code | ：3001.9010.00 |
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结构式 | ： |
CAS | ：9041-08-1 |
分子式 | ：(12H16NS2Na3)20 |
用途 | ：肝素钠是从猪小肠粘膜中提取的粘多糖类生化药品具有较强的抗凝活性。Mclcan 在研究凝血机制时从狗的肝脏组织中发现了这种股性粘多糖物质肝素。具有抗凝血活性， 在肝素第次作为临床应用的抗凝血剂之后， 受到了世界各国的重视，肝素具有较强的抗凝作用，是防治深层静脉血栓形成等血栓疾病的首选药物。 |
| Items | Standard |
|---|---|
Identification | A. H-NMR Spectrum: Comply with the USP35 specification of heparin about H-NMR requirements B. Chromatographic identity: The retention time of the major peak from the Sample solution corresponds to that from the Standard solution C. Anti-Factorxa to Anti-factor IIa Ratio:0.9~1.1 D. Sodium: It meets the requirements of the flame test for sodium |
Residue on ignition | 28.0%~41.0% |
Nitrogen(calculated on the dried basis) | 1.3%~2.5% |
Heavy metals | ≤30ppm |
Limit of galactosamine in total hexosamine | ≤1% |
Nucleotidic impurities | Absorbance at 260nm:≤0.20 |
Absence of oversulfated chondroitin dulfate | A. Proceed as directed in identification test A. No featurcs associated with oversulfated chondroitin sulfate are found between 2.12 and 3.00ppm B.Proceed as dired in identification test B.No peaks corresponding to oversulfated chondroiton sulfate shoud be detected eluting after the heparin peak. |
PH | 5.0~7.5 |
Loss on drying | ≤5.0% |
Protein impurities | ≤1.0% |
Bacterial endotoxins test | Not more than 0.03 USPEU/USPU of Heparin |
Potency (calculated on the dried basis) | ≥180USP U/mg |
Residual solvents | Ethanol: Not more than 5000 ppm |
Microbial contamination | A: Total viable aerobic count: max.10CFU/g B:Molds/yeasts. max USP3 |
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