品    名 肝素鈉 批    號 GL130701
規(guī)    格 Injectable Grade 數(shù)    量    5200  mega
生產(chǎn)日期 2013.07.01 檢驗日期 2013.07.02
檢驗依據(jù) BP2007/USP32EPV 有 效 期 2015.07.01
檢驗項目 檢驗指標 檢驗結果
來源 Porcine intestinal mucosae Porcine intestinal mucosae
性狀n A white or almost white powder A white powder
鑒別 Reaction of sodium Reaction of sodium
比旋度 ≥+35.0° +51.1°
酸堿度 5.5-8.0 6.4
溶解性 Dissolved in 2.5 times of water Complies
澄清度 640nm≤0.018 0.003
顏色 Colourless Complies
吸光度 260nm≤0.100  280nm≤0.100
400nm≤0.020  420nm≤0.018
470nm≤0.015 260nm 0.059  280nm 0.042
400nm 0.020  420nm 0.013
470nm 0.007
氮含量 1.3%-2.5% 2.2%
鈉含量 9.5%-12.5% 12.5%
硫含量 ≥10.0% 15.5%
鈣含量 Without Without
蛋白質 Without Without
干燥失重 ≤5.0% 2.7%
重金屬 ≤20ppm Complies
熾灼殘渣 20.0%-40.0% 37.6%
xj內毒素 ≤0.05IU/ Heparin Unit Complies
xj ≤10CFU/g Complies
霉菌 Without Without
致病菌 Without Without
效價 ≥180IU/mg 190.7IU/mg
無水效價 / 196.0 IU/mg
殘留溶劑 ≤5000ppm 4309ppm
結論 Comply with the standard